Brief Title
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
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.
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 nivolumab.
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 nivolumab in subjects with advanced
solid tumors. Cohort expansion will be explored evaluating COM701 monotherapy and in
combination with nivolumab 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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs).
Secondary Outcome
Incidence of subjects with Anti-COM701 antibody.
Condition
Advanced Cancer
Intervention
COM701
Study Arms / Comparison Groups
P1a Arm A (Monotherapy Dose Escalation).
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
140
Start Date
September 6, 2018
Completion Date
December 2021
Primary Completion Date
June 2021
Eligibility 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
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
COM701 Study Director, 415-770-0922, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03667716
Organization ID
CPG-01-001
Responsible Party
Sponsor
Study Sponsor
Compugen Ltd
Collaborators
Bristol-Myers Squibb
Study Sponsor
COM701 Study Director, Study Director, Compugen USA, Inc.
Verification Date
March 2021