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Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609776
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE May 24, 2016
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]
    The Dose Limiting Toxicity (DLT) is based on drug related adverse events and includes unacceptable hematologic toxicity, non-hematologic toxicity of Grade 3 or higher, or elevations in hepatic enzymes suggestive of drug-induced liver injury.
  • Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (30 [+7] days after the last dose) ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Part 2: Overall Response Rate (ORR) [ Time Frame: Up to End of Treatment Follow (EOT) Up Period (30 [+7] days after the last dose) ]
    Overall response rate (ORR) is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). CR: disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size (< 10 mm short axis) and normalisation of tumour marker levels; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and Persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
  • Part 2: Duration of Response (DOR) [ Time Frame: Up to EOT Follow Up Period (30 [+7] days after the last dose) ]
    DOR will be calculated as time from initial response of CR (disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size ([<] 10 [mm] short axis) and normalisation of tumour marker levels) or PR (at least a 30 [%] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits or durable stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits) to progressive disease (PD) or death due to underlying disease, whichever comes first, only for participants who achieve CR or PR.
  • Part 2: Percentage of Participants With Clinical Benefit [ Time Frame: Up to EOT Follow Up Period (30 [+7] days after the last dose) ]
    Clinical benefit rate is defined as the percentage of participants achieving complete response (CR): disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size (less than [<] 10 millimeter [mm] short axis) and normalisation of tumour marker levels or partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits or durable stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
  • Trough Serum Concentration (Ctrough) of JNJ-61186372 [ Time Frame: Up to EOT (30 days after last dose) ]
    Ctrough is the observed serum concentration immediately prior to the next administration.
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-61186372 [ Time Frame: Up to EOT (30 days after last dose) ]
    The AUCtau is the area under the serum concentration-time curve during a dose interval time period (tau)
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]
    The Dose Limiting Toxicity (DLT) is based on drug related adverse events and includes unacceptable hematologic toxicity, non-hematologic toxicity of Grade 3 or higher, or elevations in hepatic enzymes suggestive of drug-induced liver injury.
  • Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
  • Maximum Serum Concentration (Cmax) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through end of infusion (EOT) or Follow Up (approximately 16 months) (each cycle is of 28 days) ]
    The Cmax is the maximum observed serum concentration of JNJ-61186372.
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    The Tmax is defined as time to reach maximum observed serum concentration of JNJ-61186372.
  • Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    The AUC(t1-t2) is the area under the serum JNJ-61186372 concentration-time curve from time t1 to t2.
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    The AUCtau is the area under the serum concentration-time curve during a dose interval time period (tau)
  • Trough Serum Concentration (Ctrough) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    The Ctrough is the observed serum concentration immediately prior to the next administration.
  • Maximum Serum Concentration (Cmax) of Lzertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
    Cmax is the maximum observed serum concentration of lazertinib.
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of Lazertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
    Tmax is defined as time to reach maximum observed serum concentration of lazertinib.
  • Trough Serum Concentration (Ctrough) of Lazertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
    Ctrough is the observed serum concentration immediately prior to the next administration.
  • Accumulation ratio (R) of JNJ-61186372 [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    The R is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.
  • Number of Participants With Anti-Drug Antibodies (ADA) [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
    Serum levels of antibodies to JNJ-61186372 for evaluation of potential immunogenicity.
  • Progression-Free Survival (PFS) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
    PFS is defined as the time from first infusion of study drug to PD or death due to any cause.
  • Time to Treatment Failure (TTF) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
    TTF is defined as the time from the first infusion of the study drug to discontinuation of treatment for any reason, including disease progression, treatment toxicity, death, and will be utilized to capture clinical benefit for patients continuing treatment beyond RECIST v1.1 defined disease progression.
  • Overall Survival (OS) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
    OS is defined as the time from first infusion of study drug to death due to any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Maximum Serum Concentration (Cmax) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The Cmax is the maximum observed serum concentration of JNJ-61186372.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The Tmax is defined as actual sampling time to reach maximum observed concentration of JNJ-61186372.
  • Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The AUC(t1-t2) is the area under the serum JNJ-61186372 concentration-time curve from time t1 to t2.
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.
  • Trough Plasma Concentration (Ctrough) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
  • Accumulation ratio (R) of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    The R is obtained by dividing AUC at two different time points.
  • Immunogenicity of JNJ-61186372 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    Plasma levels of antibodies to JNJ-61186372 for evaluation of potential immunogenicity.
  • Number of Participants With Objective Response Rate [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    Objective Response Rate (ORR) is defined based on Response Criteria in Solid Tumors (RECIST) v1.1.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer
Brief Summary The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of JNJ-61186372 as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (JNJ-61186372 in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).
Detailed Description This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consists of 2 parts. Part 1 is a JNJ-61186372 Monotherapy and Combination Dose Escalations and Part 2 JNJ-61186372 Monotherapy and Combination Dose Expansions. In Part 1, participants with evaluable NSCLC will be enrolled into cohorts at increasing dose levels of JNJ-61186372 monotherapy, the RP2CD of the JNJ-61186372 and lazertinib combination which will be administered in 28 day treatment cycles, and RP2q3W of JNJ-61186372 in combination with standard of care carboplatin and pemetrexed (chemotherapy combination) which will be administered in 21 day treatment cycles. The dose will be escalated until the maximum tolerated dose (MTD, or maximum administered dose [MAD], if no MTD is found) is reached. Part 1 will follow a traditional 3+3 design. At each dose level, 3 participants will complete Cycle 1. If no dose limiting toxicity (DLT) occurs in these 3 participants, then escalation will continue in a new cohort of 3 participants. Data from Part 1 will be used to determine one or more RP2D regimen(s). In Part 2, participants with documented epidermal growth factor receptor (EGFR) mutations and measurable disease, whose disease has progressed after previous treatment will be enrolled and receive JNJ-61186372 at the RP2D determined in Part 1 as a monotherapy at the RP2D regimen(s), or in combination with lazertinib at the RP2CD regimen. For both parts, the study consists of following periods: an optional pre-Screening period; a Screening period (up to 28 days prior to the first dose of study drug); a Treatment period (first dose of study drug until 30(+7) days after the last dose of study drug or prior to starting any subsequent anti-cancer treatment, whichever comes first); and a Follow Up period (approximately 6 months). All participants will be followed for survival in the post-treatment follow-up period until the end of study and safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE
  • Drug: JNJ-61186372
    The first cohort of participants will receive IV infusions of JNJ-61186372 140 mg as monotherapy. Each subsequent cohort will receive IV infusions of JNJ-61186372 at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive lazertinib and JNJ-61186372 at predefined dose levels, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days. In Chemotherapy Combination Cohort, participants will receive JNJ-61186372, administered on a 21-day cycle, in combination with the administration of standard of care carboplatin and pemetrexed.
  • Drug: JNJ-61186372
    Participants will receive IV infusion of JNJ-61186372 as monotherapy at RP2D regimen or in combination lazertinib at RP2CD regimen as determined in Part 1.
  • Drug: Lazertinib
    Lazertinib will be administered in combination with JNJ-61186372 at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily on the 28-day JNJ-61186372 treatment cycle.
  • Drug: Carboplatin
    Participants will receive carboplatin in combination with pemetrexed and JNJ-61186372 as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.
  • Drug: Pemetrexed
    Participants will receive pemetrexed in combination with carboplatin and JNJ- 61186372 as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.
Study Arms  ICMJE
  • Experimental: Part 1:JNJ-61186372 Monotherapy+Combination Dose Escalations
    The first cohort of participants will receive intravenous (IV) infusions of JNJ-61186372 140 milligram (mg) as monotherapy. Each subsequent cohort will receive IV infusions of JNJ-61186372 at increased dose level. Dose escalation will continue until maximum tolerated dose is reached or all planned doses are administered. Participants will receive IV infusion of JNJ-61186372 once weekly during cycle 1 and once every 2 weeks during subsequent cycles (duration of each treatment cycle is 28 days). Participants will receive lazertinib and JNJ-61186372 on Cycle 1 Day 1 (C1D1) prior to initiation of JNJ-61186372 (C1D1) at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily thereafter, on 28-day JNJ-61186372 treatment cycle. In Chemotherapy Combination Cohort, participants will receive JNJ-61186372, administered on a 21-day cycle, in combination with standard of care carboplatin and pemetrexed.
    Interventions:
    • Drug: JNJ-61186372
    • Drug: Lazertinib
    • Drug: Carboplatin
    • Drug: Pemetrexed
  • Experimental: Part 2:JNJ-61186372 Monotherapy+Combination Dose Expansion
    Participants will receive IV infusion of JNJ-61186372 as monotherapy at Phase 2 dose (RP2D) regimen or in combination lazertinib at the recommended Phase 2 combination dose (RP2CD) regimen as determined in Part 1. The purpose of dose expansion is to further evaluate safety, tolerability, pharmacokinetic, and to assess preliminary efficacy in monotherapy and combination therapy cohorts.
    Interventions:
    • Drug: JNJ-61186372
    • Drug: Lazertinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
460
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2015)
50
Estimated Study Completion Date  ICMJE July 20, 2022
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is metastatic or unresectable. Participants must have either progressed after prior standard of care therapy (Cohort C and hepatocyte growth factor receptor gene [MET]-1: epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]; Cohort D and MET-2: platinum-based chemotherapy) for metastatic disease, or be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records. For Part 1 Chemotherapy Combination Cohort only: Participants must have histologically or cytologically confirmed NSCLC that is metastatic or unresectable and be eligible for treatment with combination carboplatin and pemetrexed, in accordance with standard of care, and be willing to receive additional investigational therapy with JNJ-61186372
  • For Part 1 Combination Dose Escalation with lazertinib only: Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and (a) be treatment naïve for metastatic disease, without access to third generation TKI in the front-line setting, or (b) have progressed after front-line treatment with first (erlotinib or gefitinib) or second generation (afatinib) TKI and are ineligible for Cohort MET-1, or (c) have been treated with a third generation TKI (eg, osimertinib) in either the front line or second-line setting, and are not eligible for enrollment in either Cohort C or MET-1. For Part 1 Chemotherapy Combination Cohort: Participants may be diagnosed with EGFR mutated or EGFR wild type NSCLC. For Part 2 only: Participants must also have disease with a previously diagnosed activating epidermal growth factor receptor (EGFR) mutation (includes both inhibitor sensitive primary mutations such as Exon 19 deletion and L858R (Cohort C, E, and MET-1), as well as marketed TKI-resistant mutations such as Exon 20 insertion (Cohort C, D and MET-1) or activating cMet Exon 14 skipping mutation (Cohort MET-2). Documentation of primary activating EGFR or cMet mutation eligibility by CLIA-certified laboratory (or equivalent) testing is required
  • For Part 1: Participant must have evaluable disease. For Part 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
  • For Part 2: Cohorts A and B: Participants EGFR mutated disease must have most recently progressed following treatment with a marketed EGFR inhibitor. Exception: In participants diagnosed with mutations associated with de novo EGFR inhibitor resistance (for example, Exon 20 insertions), only previous treatment with combination platinum-based chemotherapy is required. Cohort C: Participants with primary EGFR mutated disease, with a documented EGFR alteration (example, C797S) mediating resistance to previous treatment with a third generation EGFR TKI (for example, osimertinib), in participants with primary Exon 20ins disease, the documented EGFR alteration may arise following treatment with a TKI with known activity against Exon 20ins disease (for example, poziotinib). Cohort D: participants must have been previously diagnosed with an EGFR Exon 20 insertion and have not been previously treated with a TKI with known activity against Exon 20ins disease (exampe, poziotinib). Cohort MET-1: Participants with documented primary EGFR mutated disease and documented MET amplification or MET mutation after progression on any EGFR TKI. Participants with disease characterized by both MET amplification and EGFR resistance mutations to prior third generation EGFR TKI will be preferentially enrolled into Cohort C. Participants may have received or have been intolerant to prior platinum-based chemotherapy. Cohort MET-2: Participants with documented primary MET Exon 14 skipping mutation non-small cell lung cancer (NSCLC). Cohort E (combination JNJ-61186372 and lazertinib): Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation, and have progressed after first or second-line treatment with a third generation TKI (eg, osimertinib)
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension, or diabetes, ongoing or active infection, (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded. For Part 1 Chemotherapy Combination Cohort only: additionally, participants with active bleeding diathesis
  • Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer, before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anti-cancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2 hypothyroidism stable on hormone replacement). For Part 1 Combination Dose Escalation: Any previous treatment with systemic anti cancer immunotherapy, including but not limited to anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents. For Part 1 Chemotherapy Combination Cohort only: Any previous treatment with systemic anti cancer immunotherapy in the past 3 months or localized radiotherapy to lung within the past 6 months. For Part 2 only: Cohorts A and B: Prior treatment with chemotherapy for metastatic disease is not allowed unless the tumor mutation carries de-novo resistance to EGFR TKI (example, Exon 20 insertions). Cohort C and MET-1: Prior treatment with more than 2 lines of cytotoxic chemotherapy for metastatic disease (maintenance therapy is not included). Cohort D: Previous treatment with an EGFR TKI with activity against EGFR Exon 20 insertions (such as poziotinib). Cohort E (combination JNJ-61186372 and lazertinib): Any previous treatment in the metastatic setting with other than a first, second, or third generation EGFR TKI
  • Participants with untreated brain metastases. Participants with definitively, locally-treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (<=10 mg prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible. Exception: participants with asymptomatic, untreated brain metastases, each less than 1 cm in diameter, may be eligible for JNJ 61186372 and lazertinib combination therapy in the Part 1 Combination Dose Escalation or Part 2 Combination Expansion Cohort E
  • Participant has a history of malignancy other than the disease under study within 3 years before Screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with or minimal risk of recurrence within a year from Screening)
  • Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 6 months after the last dose of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Australia,   Canada,   China,   France,   Italy,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609776
Other Study ID Numbers  ICMJE CR108064
61186372EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
2018-003908-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP