Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04104672 | A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 196 | — | — | Nov 6, 2019 | May 1, 2027 | Jun 2, 2026 | 13 | United States |
Safety will be assessed by monitoring adverse events and clinically relevant changes in 12 lead Electrocardiogram (ECG) and Physical examination findings
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The dose expansion dose level will be determined in this part with escalating doses of AB680 in combination with zimberelimab at the recommended phase 2 dose (RP2D) and the standard nab-paclitaxel and gemcitabine chemotherapy regimen in participants with advanced pancreatic cancer. |
| Dose Expansion (AB680+zimberelimab+ NP/Gem): Cohort A (front-line/1L) | EXPERIMENTAL | Participants with advanced pancreatic cancer, naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and the standard nab-paclitaxel (NP) and gemcitabine (Gem) (NP/Gem) chemotherapy regimen |
| Dose Expansion (AB680+zimberelimab+NP/Gem):Cohort A1 (front-line/1L) | EXPERIMENTAL | Participants with advanced pancreatic cancer, naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and the standard nab-paclitaxel (NP) and gemcitabine (Gem) (NP/Gem) chemotherapy regimen |
| Dose Expansion (AB680 + NP/Gem): Cohort A2 (front-line/1L) | EXPERIMENTAL | Participants with advanced pancreatic cancer who are naïve to any prior treatment will receive AB680 (at the RP2D identified during dose escalation) and the standard NP/Gem chemotherapy regimen. |
| Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort B (second-line/2L) | EXPERIMENTAL | Participants with advance pancreatic cancer who have received 1 prior line of treatment will receive AB680 (at the RP2D identified during dose escalation) combined with zimberelimab and NP-Gem chemotherapy regimen. |
| Dose Expansion (AB680 + zimberelimab + NP/Gem): Cohort C (front-line/1L) | EXPERIMENTAL | Participants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with zimberelimab and NP-Gem chemotherapy regimen. |
| Dose Expansion (AB680 + NP/Gem): Cohort D (front-line/1L) | EXPERIMENTAL | Participants with advanced pancreatic cancer naïve to any prior treatment will receive AB680 combined with NP-Gem chemotherapy regimen. |
| Name | Type | Description |
|---|---|---|
| AB680 | DRUG | AB680 is a Cluster of Differentiation (CD)73 Inhibitor. |
| Zimberelimab | DRUG | Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells. |
| Gemcitabine | DRUG | Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells. |
Key Inclusion Criteria: * Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma * Naïve to any prior treatment, including chemotherapy, biological therapy, or targeted therapy for metastatic disease * Prior adjuvant therapy (including chemotherapy and/or radiotherapy) fo...