Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AB154
Domvanalimab · 5 trials · 7 indications
ORR as assessed by RECIST v1.1
Number of Participants Treated with domvanalimab or domvanalimab in Combination with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice) | EXPERIMENTAL | Participants in this arm will receive Domvanalimab and zimberelimab doses once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX (oxaliplatin, leucovorin, fluorouracil) once every 2 weeks (Q2W) or Domvanalimab and zimberelimab once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX (capecitabine and oxaliplatin) Q3W. |
| Nivolumab + FOLFOX/CAPOX (PI Choice) | ACTIVE_COMPARATOR | Participants in this arm will receive Nivolumab Q2W and FOLFOX Q2W or Nivolumab Q3W + CAPOX Q3W. |
| A1: First Line - Treatment Naïve Participants | EXPERIMENTAL | Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W) |
| A2: First Line - Treatment Naïve Participants | EXPERIMENTAL | Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W |
| A3 First Line - Treatment Naïve Participants | EXPERIMENTAL | Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W. After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W |
| A4 First Line - Treatment Naïve Participants | EXPERIMENTAL | Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W |
| B1: Second Line or greater Checkpoint Inhibitor Naïve Participants | EXPERIMENTAL | Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion |
| B2: Second Line or greater Checkpoint Inhibitor Naïve Participants | EXPERIMENTAL | Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion |
| Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants | EXPERIMENTAL | Domvanalimab and zimberelimab Q3W administered by IV infusion |
| Arm A - Study Part 1 (Platinum-based Chemotherapy) | ACTIVE_COMPARATOR | Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion. |
| Arm B - Study Part 1 (Zimberelimab Monotherapy) | EXPERIMENTAL | Participants will receive zimberelimab monotherapy by IV infusion. |
| Arm C - Study Part 1 (Domvanalimab + Zimberelimab Combination Therapy) | EXPERIMENTAL | Participants will receive zimberelimab in combination with AB154 by IV infusion. |
| Arm D - Study Part 2 (Domvanalimab + Zimberelimab Combination Therapy) | EXPERIMENTAL | Participants will receive domvanalimab in combination with zimberelimab by IV infusion. |
| Arm E - Study Part 2 (Pembrolizumab) | ACTIVE_COMPARATOR | Participants will receive pembrolizumab by IV infusion. |
| Arm 1 (zimberelimab monotherapy) | EXPERIMENTAL | Participants will receive zimberelimab as an intravenous (IV) infusion. |
| Arm 2 (domvanalimab and zimberelimab combination therapy) | EXPERIMENTAL | Participants will receive domvanalimab IV in combination with zimberelimab IV infusion. |
| Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion |
| Domvanalimab Monotherapy | EXPERIMENTAL | Varying Doses of domvanalimab Monotherapy |
| Domvanalimab + zimberelimab Q2W Combination Therapy | EXPERIMENTAL | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab + zimberelimab Q3W Combination Therapy | EXPERIMENTAL | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab + zimberelimab Q4W Combination Therapy | EXPERIMENTAL | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Domvanalimab and Zimberelimab Q6W combination therapy | EXPERIMENTAL | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W | EXPERIMENTAL | Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab |
| Name | Type | Description |
|---|---|---|
| Domvanalimab | DRUG | Intravenous (IV) Aqueous Solution |
| Zimberelimab | DRUG | IV Aqueous Solution |
| Capecitabine | DRUG | Oral Tablets |
| Fluorouracil | DRUG | IV Aqueous Solution |
| Leucovorin | DRUG | IV Aqueous Solution |
| Oxaliplatin | DRUG | IV Aqueous Solution |
| Nivolumab | DRUG | IV Aqueous Solution |
| Quemliclustat | DRUG | Administered as specified in the treatment arm |
| Carboplatin | DRUG | Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. |
| Paclitaxel | DRUG | Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. |
| Pemetrexed | DRUG | Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve. |
| Pembrolizumab | DRUG | Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor |
| Etrumadenant | DRUG | Etrumadenant is an A2aR and A2bR antagonist |
Key Inclusion Criteria: * Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol. * Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophagea...
Domvanalimab is an investigational monoclonal antibody developed by Arcus Biosciences, Inc. for oncology indications. It is being studied in advanced upper gastrointestinal tract adenocarcinoma, gastrointestinal tract malignancies, non small cell lung cancer, and solid tumors in adults. It is designed as a TIGIT inhibitor and is most often evaluated in combination with other immunotherapies and chemotherapy.
Domvanalimab targets TIGIT, an immune checkpoint receptor. It is classified as a TIGIT inhibitor, meaning it is designed to block TIGIT signaling. Blocking this checkpoint is intended to support anti-tumor immune responses, and domvanalimab is studied in combination regimens rather than as a single agent in its late-stage program.
Domvanalimab is being developed by Arcus Biosciences, Inc., which trades under the ticker RCUS. The company sponsors the clinical program, including a Phase 3 trial in advanced upper gastrointestinal tract adenocarcinoma and Phase 2 studies in gastrointestinal malignancies and non small cell lung cancer.
Domvanalimab is in Phase 3 development. Its lead program is a Phase 3 trial in advanced upper gastrointestinal tract adenocarcinoma that has been completed. Additional Phase 2 studies in gastrointestinal tract malignancies and non small cell lung cancer have also been conducted. Domvanalimab remains investigational and is not described as an approved therapy.
Domvanalimab has been studied in several registered trials. NCT05568095 is a completed Phase 3 trial combining domvanalimab and zimberelimab plus chemotherapy in advanced upper gastrointestinal tract adenocarcinoma. NCT05329766 is an active Phase 2 study in advanced upper gastrointestinal tract malignancies, and NCT04736173 and NCT04262856 are completed Phase 2 studies in non small cell lung cancer.
Domvanalimab is administered as part of combination regimens in its clinical trials. The Phase 3 NCT05568095 study evaluated domvanalimab together with zimberelimab and chemotherapy in advanced upper gastrointestinal tract adenocarcinoma. Other studies tested combination immunotherapies with and without chemotherapy in gastrointestinal malignancies and non small cell lung cancer.