COM701 (an Inhibitor of PVRIG) 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03667716|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2018
Last Update Posted : February 6, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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 Colo-rectal Cancer||Drug: COM701 Drug: COM701 with Opdivo (Nivolumab).||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||December 2023|
|Estimated Study Completion Date :||December 2023|
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.
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.
Drug: COM701 with Opdivo (Nivolumab).
COM701 in combination 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).
Experimental: P1b (Combination Cohort Dose Expansion).
COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer).
Drug: COM701 with Opdivo (Nivolumab).
COM701 in combination with Opdivo (Nivolumab).
- 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 or 28 days). ]To evaluate the safety profile of COM701 monotherapy and in combination with nivolumab.
- Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with nivolumab). [ Time Frame: Approximately 2 year. ]
- Incidence of subjects with Anti-COM701 antibody. [ Time Frame: Approximately 2 years. ]Immunogenicity of COM701 monotherapy and in combination with nivolumab.
- Overall Response Rate as per RECIST v1.1 [ Time Frame: Approximately 2 years. ]Preliminary antitumor activity of COM701 in combination with nivolumab.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy 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 nivolumab):
- 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. P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
- Endometrial cancer: Subjects with locally advanced or metastatic endometrial cancer, disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy. P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
- 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). P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
- 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). COM701 monotherapy expansion cohort.
- CRC (microsatellite stable, KRAS mutation) - P1b COM701 + nivolumab expansion cohort, COM701 monotherapy expansion cohort.
- 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.
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
|United States, California|
|University of California Los Angeles (UCLA).|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|Florida Cancer Specialists|
|Sarasota, Florida, United States, 34230|
|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|
|Grand Rapids, Michigan, United States, 49503|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Ohio|
|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|
|Study Director:||COM701 Study Director||Compugen USA, Inc.|
|Responsible Party:||Compugen Ltd|
|Other Study ID Numbers:||
|First Posted:||September 12, 2018 Key Record Dates|
|Last Update Posted:||February 6, 2023|
|Last Verified:||February 2023|
|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|
DNAM (DNAX Accessory molecule 1)
Poliovirus receptor-related immunoglobulin
Triple Negative Breast Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Respiratory Tract Neoplasms
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action