Clinical trial · Interventional
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies
NCT04354246CI-TRIAL-00121626completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 in subjects with advanced malignancies.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Microsatellite Stable Colorectal Carcinoma | Microsatellite Stable Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| MSS-CRC | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort expansion: COM902 in combination with COM701 (both at the RDFE). | Drug | — | UNRESOLVED |
| Cohort expansion: COM902 (RDFE) monotherapy. | Drug | — | UNRESOLVED |
| Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab. | Combination Product | — | UNRESOLVED |
| Dose escalation: COM902 monotherapy. | Drug | — | UNRESOLVED |
| Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- COM902 monotherapy dose escalation.
- description
- Monotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified.
- interventionNames
- Drug: Dose escalation: COM902 monotherapy.
- type
- EXPERIMENTAL
- label
- Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).
- description
- COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
- interventionNames
- Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
References
Publications (0)
Data not yet available
No reference posted for this study.