Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...