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GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

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: NCT04601402
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Merck KGaA, Darmstadt, Germany
Pfizer
Information provided by (Responsible Party):
Genome & Company

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date October 23, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Dose Escalation: Incidence of Adverse Events [ Time Frame: 1 years ]
    Assessed as per CTCAE v5.0
  • Dose Escalation: Incidence of Laboratory abnormalities [ Time Frame: 1 years ]
    Assessed as per CTCAE v5.0
  • Dose Escalation: Incidence of dose-limiting toxicity (DLT) [ Time Frame: 1 Cycle (one cycle = 28 days) ]
    To evaluate the safety and tolerability of GEN-001 in combination with avelumab
  • Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab. [ Time Frame: 2 years ]
    Confirmed OR per RECIST v1.1 by the Investigator
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Objective Response (OR) [ Time Frame: 1 years ]
    Assessed according to RECIST v1.1
  • Duration of response (DoR) [ Time Frame: up to 2 years ]
    Assessed according to RECIST v1.1
  • Progression-free survival (PFS) [ Time Frame: up to 2 years ]
    Assessed according to RECIST v1.1
  • Overall Survival (OS) [ Time Frame: up to 2 years ]
  • Incidence of Adverse Events [ Time Frame: up to 2 years ]
    Assessed as per CTCAE v5.0
  • Incidence of Laboratory Abnormalities [ Time Frame: up to 2 years ]
    Assessed as per CTCAE v5.0
  • irOR (Immune-related Objective Response) [ Time Frame: up to 2 years ]
    Assessed according to irRECIST
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 19, 2020)
  • Ctrough [ Time Frame: up to 2 years ]
    Ctrough for PK parameter
  • ADA [ Time Frame: up to 2 years ]
    Anti-Drug Antibodies(ADA) for Immunogenicity
  • Microbiota [ Time Frame: up to 2 years ]
    fecal samples will be collected for analysis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
Official Title  ICMJE A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy
Brief Summary This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
Dose Escalation: Seqeuntial Group Assignment, Dose Expansion: Parallel Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Urothelial Carcinoma
Intervention  ICMJE
  • Drug: GEN-001
    The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10^11 colony-forming units (CFU)
  • Drug: Avelumab
    800 mg given by intravenous (IV) infusion once every 2 weeks
    Other Name: Bavencio
Study Arms  ICMJE Experimental: GEN-001 with avelumab

Dose Escalation Cohort includes patients with advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels.

Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)will be enrolled.

Interventions:
  • Drug: GEN-001
  • Drug: Avelumab
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: October 19, 2020)
93
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have adequate organ functions as defined in the protocol
  • Negative childbearing potential
  • Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities
  • Patients with diseases for which no curative therapies are available, and who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)
  • Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
  • Patients who have completely recovered from any clinically significant AEs that occurred during prior immunotherapy
  • Estimated life expectancy of at least 3 months
  • Objective evidence of disease progression at baseline (Dose Escalation)
  • Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic NSCLC, SCCHN, and UC (Dose Expansion)
  • Measurable disease as per RECIST v1.1 defined as at least 1 lesion (Dose Expansion)

Exclusion Criteria:

  • Have experienced primary resistance to anti-PD-(L)1 based therapy
  • Has experienced a toxicity that led to permanent discontinuation of prior anti-PD-(L)1 based therapy or other immunotherapies
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Current use of immunosuppressive medication at time of study entry
  • Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within the previous 4 weeks of starting study treatment
  • Has received a live vaccine within 4 weeks of starting of study treatment
  • Known history of, or any evidence of active, non-infectious pneumonitis
  • Prior solid organ or allogeneic stem cell transplantation
  • Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks of starting study treatment
  • Has received proton pump inhibitors (PPIs) within 2 weeks prior to dosing study treatments
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has clinically significant (i.e., active) cardiovascular disease
  • Has known history of uncontrolled intercurrent illness
  • Has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.
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: Clinical Development +82316280150 GNC_Clinical@genomecom.co.kr
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04601402
Other Study ID Numbers  ICMJE [GNC] GEN001-101
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party Genome & Company
Study Sponsor  ICMJE Genome & Company
Collaborators  ICMJE
  • Merck KGaA, Darmstadt, Germany
  • Pfizer
Investigators  ICMJE
Principal Investigator: Shivaani Kummar, MD Oregon Health and Science University
PRS Account Genome & Company
Verification Date October 2020

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