A Phase 1 Study of the Safety and Tolerability of COM902 in Subjects with Advanced Malignancies
A Phase 1 Study of the Safety and Tolerability of COM902 in Subjects with Advanced Malignancies
NCT #
NCT04354246
Condition(s)
Ovarian
Molecular Target(s)
TIGIT& PVRIG
Drug Classification(s)
Monoclonal Antibody
Agents(s)
TIGIT& PVRIG
Phase(s)
I
Mechanism of Action
COM701 is a monoclonal antibody against the poliovirus receptor-related immunoglobulin (PVRIG; PVR Related Immunoglobulin Domain Containing Protein; CD112R), a regulatory signal molecule expressed on cytotoxic T lymphocytes and NK cells. Blockade of PVRIG can prevent PVRIG-induced inhibition of T-lymphocyte and NK-cell activation. This sequence could enhance anti-tumor responses and immune-mediated tumor cell killing.
Purpose
- How much of study agent 1 can be given alone and in combination with study agent 2 and Pembrolizumab with an acceptable level of side effects
- The effects of the study agents (good and bad)
- How much of the study agents are absorbed into the blood and how fast they are removed
- If research tests can be used in the future to predict who will benefit from the study agent 1 and/or study agent 2
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- For Triplet combination MSS-CRC:
- Histologically confirmed adenocarcinoma of the colon/rectum
- Stage IV disease
- MSS-CRC status by an FDA approved test
- Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin
- For Triplet combination ovarian cancer:
- Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Platinum resistant ovarian cancer (PROC) defined as disease recurrence < 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
- Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
- Subjects who have received PARP inhibitor therapy are eligible
- Prior treatment with a TIGIT inhibitor.
- Prior treatment with an inhibitor of PVRIG
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment discontinuation
No more than 3 prior LOT including fluroropyrimidines, irinotecan, and oxaliplatin
No prior treatment with anti-PD-1 or anti-PD-L1-directed therapy
Location
MCD
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