Clinical Trial - NCT03667716

COM701 in Subjects With Advanced Solid Tumors

Recruiting

Sponsor: Compugen Ltd

Collaborators: Bristol-Myers Squibb

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03667716

Protocol Info

Short Description: Phase 1a/1B COM701 +/- Anti-PD-1 Antibody in Subjects with Advanced Solid Tumors
Long Description: A Phase 1a/1b Study of COM701 as Monotherapy and In Combination with an Anti-PD-1 Antibody in Subjects with Advanced Solid Tumors
MGH Status: Open
Sponsor: Compugen Ltd.
Disease Program: Phase I

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Advanced Cancer Ovarian Cancer Breast Cancer Lung Cancer Endometrial Cancer Ovarian Neoplasm Triple Negative Breast Cancer Lung Neoplasm Neoplasm Malignant COM701 COM701 with Opdivo (Nivolumab). Phase 1
Study Type Interventional
Official Title A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors

Primary Outcome Measures

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).] [Designated as safety issue: ]

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.] [Designated as safety issue: ]


Secondary Outcome Measures

Incidence of subjects with Anti-COM701 antibody. [Time Frame: Approximately 2 years.] [Designated as safety issue: ]

Overall Response Rate as per RECIST v1.1 [Time Frame: Approximately 2 years.] [Designated as safety issue: ]

Estimated Enrollment: 140
Study Start Date: September 2018
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: January 2020
Arms Assigned Interventions

Experimental:P1a Arm A (Monotherapy Dose Escalation).

COM701 monotherapy sequential dose escalation administered IV every 3 weeks. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
Drug:COM701
COM701 monotherapy.

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.
Drug:COM701 with Opdivo (Nivolumab).
COM701 in combination with Opdivo (Nivolumab).

Experimental:P1a Arm A (Monotherapy Expansion).

COM701 monotherapy administered IV every 3 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian and Endometrial cancer).

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 and Endometrial cancer).

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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).
  • 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03667716

Locations

  • United States, California
    • University of California Los Angeles (UCLA). Los Angeles, California, United States, 90095
  • United States, Illinois
    • University of Chicago Medical Center Chicago, Illinois, United States, 60637
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • START Midwest. Grand Rapids, Michigan, United States, 49503
  • United States, New York
    • Columbia University New York, New York, United States, 10032
  • United States, Ohio
    • Cleveland Clinic. Cleveland, Ohio, United States, 44195
  • United States, Tennessee
    • The University of Tennessee WEST Cancer Center. Memphis, Tennessee, United States, 38138
    • Sarah Cannon Research Institute. Nashville, Tennessee, United States, 37203
  • United States, Texas
    • M D Anderson Cancer Center. Houston, Texas, United States, 77030
    • The START Center for Cancer Care. San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Compugen Ltd

Bristol-Myers Squibb

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03667716
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Compugen Ltd:

PVRIG

advanced cancer

checkpoint inhibitor

DNAM (DNAX Accessory molecule 1)

PD-1 inhibitor

CD112

CD 112R

Poliovirus receptor-related immunoglobulin

PVRL2

Nivolumab

opdivo

Additional relevant MeSH terms:

Breast Neoplasms

Neoplasms

Endometrial Neoplasms

Triple Negative Breast Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Nivolumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019