CLINICAL TRIAL / NCT03667716
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
- Interventional
- Recruiting
- NCT03667716
Contact Information
A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors.
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.
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.
Gender
All
Age Group
18 Years and up
Accepting 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.