Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COM701 in Subjects With Advanced Solid Tumors

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: NCT03667716
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Compugen Ltd

Tracking Information
First Submitted Date  ICMJE September 10, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE September 6, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs). [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]
    To evaluate the safety profile of COM701 monotherapy and in combination with a PD-1 inhibitor.
  • Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with a PD-1 inhibitor). [ Time Frame: Approximately 2 year. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs) [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]
    To evaluate the safety profile of COM701 monotherapy and in combination with a PD-1 inhibitor.
  • Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with a PD-1 inhibitor). [ Time Frame: Approximately 1 year. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Incidence of subjects with Anti-COM701 antibody. [ Time Frame: Approximately 2 years. ]
    Immunogenicity of COM701 monotherapy and in combination with a PD-1 inhibitor.
  • Overall Response Rate as per RECIST v1.1 [ Time Frame: Approximately 2 years. ]
    Preliminary antitumor activity of COM701 in combination with a PD-1 inhibitor.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Incidence of subjects with Anti-COM701 antibody. [ Time Frame: Approximately 2 years. ]
    Immunogenicity of COM701 monotherapy and in combination with a PD-1 inhibitor.
  • Objective Response Rate as per RECIST v1.1 [ Time Frame: Approximately 2 years. ]
    Preliminary antitumor activity of COM701 in combination with a PD-1 inhibitor
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COM701 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors
Brief Summary This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with a programmed cell death protein 1 (PD-1) inhibitor.
Detailed Description This Phase 1 study evaluates the safety, tolerability, Pharmacokinetics (PK) and preliminary clinical activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) as monotherapy and in combination with a PD-1 inhibitor in subjects with advanced solid tumors. Cohort expansion will be explored evaluating COM701 monotherapy and in combination with a PD-1 inhibitor in subjects with the following select tumor types (Non-Small cell lung cancer (NSCLC), Ovarian, Breast (including Triple negative breast cancer (TNBC) and endometrial cancer. Other tumor types such as CRC-MSS, CRC-KRAS mutant will be enrolled based on emerging clinical activity data.
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
  • Advanced Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Lung Cancer
  • Endometrial Cancer
  • Ovarian Neoplasm
  • Triple Negative Breast Cancer
  • Lung Neoplasm
  • Neoplasm Malignant
  • Colo-rectal Cancer
Intervention  ICMJE
  • Drug: COM701
    COM701 monotherapy.
  • Drug: COM701 with Opdivo (Nivolumab).
    COM701 in combination with Opdivo (Nivolumab).
Study Arms  ICMJE
  • Experimental: P1a Arm A (Monotherapy Dose Escalation).
    COM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
    Intervention: Drug: COM701
  • Experimental: P1a Arm B (Combination Dose Escalation).
    COM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks.
    Interventions:
    • Drug: COM701
    • Drug: COM701 with Opdivo (Nivolumab).
  • Experimental: P1a Arm A (Monotherapy Expansion).
    COM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer).
    Intervention: Drug: COM701
  • Experimental: P1b (Combination Cohort Dose Expansion).
    COM701 administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial cancer and Colorectal cancer).
    Interventions:
    • Drug: COM701
    • Drug: COM701 with Opdivo (Nivolumab).
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: September 11, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Subjects who received prior immune-stimulatory antitumor agents, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, OX-40, CD137, etc. are eligible.
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all the available standard therapy or is not a candidate for the available standard therapy.

Select Tumor Types (COM701 monotherapy cohort expansion; COM701 in combination with a PD-1 inhibitor):

  • Breast cancer (TNBC): Histologically confirmed incurable, advanced estrogen receptor-, progesterone receptor-, and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) adenocarcinoma of the breast, as defined by the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines. Disease recurrence or progression during or after at least one systemic treatment that included an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting. Subjects must have progressed after a poly ADP-ribose polymerase (PARP) inhibitor for patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutated metastatic breast cancer.
  • Endometrial cancer: Subjects with locally advanced or metastatic endometrial cancer, Disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy.
  • Ovarian cancer: Disease recurrence or progression during or after prior therapy that included: surgical resection, platinum agent, PARP inhibitor (for subjects with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer or as a maintenance therapy for subjects who have had complete or partial response to platinum-based therapy).
  • NSCLC: Documented stage IIIB or IV or recurrent NSCLC, Disease recurrence or progression during or after prior treatment that included: platinum agent, targeted therapy such as a TKI (if with biopsy-confirmed cytogenetic mutation eg EGFR, ROS, BRAF).
  • CRC (microsatellite stable, KRAS mutation)
  • For Phase 1a monotherapy expansion and Phase 1b only: subject has at least one measurable lesion that could be followed during the study according to RECIST v1.1.

Key Exclusion Criteria:

  • Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
  • Symptomatic interstitial lung disease or inflammatory pneumonitis.
  • History of immune-related events that lead to immunotherapy treatment discontinuation.
  • Untreated or symptomatic central nervous system (CNS) metastases.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following: a) Unstable angina pectoris ≤ 6 months prior to first scheduled dose of COM701; b) Acute myocardial infarction ≤ 6 months prior to first scheduled dose of COM701.
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: Lead COM701 ClinInfo 415-770-0922 COM701-001@cgen.com
Contact: Backup COM701 ClinInfo 415-770-0922 COM701-001@cgen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667716
Other Study ID Numbers  ICMJE CPG-01-001
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 Compugen Ltd
Study Sponsor  ICMJE Compugen Ltd
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: COM701 Study Director Compugen USA, Inc.
PRS Account Compugen Ltd
Verification Date June 2020

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