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COM701 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03667716
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Compugen Ltd

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Ovarian Cancer Breast Cancer Lung Cancer Endometrial Cancer Ovarian Neoplasm Triple Negative Breast Cancer Lung Neoplasm Neoplasm Malignant Drug: COM701 Drug: COM701 with Opdivo (Nivolumab). Phase 1

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 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) evaluating COM701 monotherapy and in combination with a PD-1 inhibitor will be explored.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
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
COM701 monotherapy.

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).
Drug: COM701
COM701 monotherapy.

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).
Drug: COM701
COM701 monotherapy.

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




Primary Outcome Measures :
  1. 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.

  2. 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. ]

Secondary Outcome Measures :
  1. Incidence of subjects with Anti-COM701 antibody. [ Time Frame: Approximately 2 years. ]
    Immunogenicity of COM701 monotherapy and in combination with a PD-1 inhibitor.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667716


Contacts
Contact: Lead COM701 ClinInfo 415-770-0922 COM701-001@cgen.com
Contact: Backup COM701 ClinInfo 415-770-0922 COM701-001@cgen.com

Locations
United States, Tennessee
The University of Tennessee WEST Cancer Center. Recruiting
Memphis, Tennessee, United States, 38138
Contact: COM701 Study Director    415-770-0922    COM701-001@cgen.com   
Sarah Cannon Cancer Institute. Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: COM701 Study Director    415-770-0922    COM701-001@cgen.com   
United States, Texas
The START Center for Cancer Care. Recruiting
San Antonio, Texas, United States, 78229
Contact: COM701 Study Director    415-770-0922    COM701-001@cgen.com   
Sponsors and Collaborators
Compugen Ltd
Investigators
Study Director: COM701 Study Director Compugen USA, Inc.

Responsible Party: Compugen Ltd
ClinicalTrials.gov Identifier: NCT03667716     History of Changes
Other Study ID Numbers: CPG-01-001
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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:
Ovarian Neoplasms
Breast Neoplasms
Neoplasms
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs