Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AB680 · 4 trials · 3 indications
PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator
ORR according to RECIST v1.1, as assessed by the Investigator
Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis
Safety will be assessed by monitoring adverse events and clinically relevant changes in 12 lead Electrocardiogram (ECG) and Physical examination findings
Number of Participants with TEAEs as Assessed by CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion. |
| mFOLFOX-6 +/- Bevacizumab | ACTIVE_COMPARATOR | Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion. |
| Regorafenib | ACTIVE_COMPARATOR | Participants will receive oral regorafenib |
| AB680 + Etrumadenant + Zimberelimab | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion. |
| Active: Dose Escalation | ACTIVE_COMPARATOR | Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random. |
| Placebo: Dose Escalation | PLACEBO_COMPARATOR | Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random. |
| 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 differentiated CD73 Inhibitor |
| Etrumadenant | DRUG | Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist |
| Zimberelimab | DRUG | Zimberelimab is a fully human anti-PD-1 monoclonal antibody |
| Bevacizumab | DRUG | Bevacizumab is administered as part of standard chemotherapy regimen |
| m-FOLFOX-6 regimen | DRUG | mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen |
| Regorafenib | DRUG | Regorafenib is administered as part of standard chemotherapy regimen |
| Placebo | OTHER | Matching Placebo |
| 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. |
Inclusion Criteria: * Male and female participants ≥ 18 years of age * Histologically confirmed metastatic colorectal adenocarcinoma * Must have at least 1 measurable lesion per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy at least 3 months ...
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AB680 is an investigational small molecule developed by Arcus Biosciences, Inc. (ticker RCUS) as a CD73 inhibitor. It is being studied in oncology, including advanced pancreatic cancer and metastatic colorectal cancer, and has also been evaluated in healthy volunteers. It remains in Phase 1 clinical development.
AB680 targets CD73, a protein enzyme. By inhibiting CD73, the drug is designed to act on the adenosine pathway within the tumor microenvironment. This CD73-directed mechanism is the basis for its study in oncology indications such as advanced pancreatic cancer and metastatic colorectal cancer.
AB680 is developed by Arcus Biosciences, Inc., which trades under the ticker RCUS. The company is the sponsor of the clinical studies evaluating AB680 in oncology and in healthy volunteer populations.
AB680 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The completed Phase 1 studies have evaluated the drug in participants with gastrointestinal malignancies and healthy volunteers.
AB680 has been studied in Phase 1 trials including NCT04104672 in participants with gastrointestinal malignancies such as advanced pancreatic cancer, NCT04575311 and NCT03677973 in healthy volunteers, and NCT04660812, which evaluated etrumadenant (AB928) based treatment combinations in metastatic colorectal cancer.
No. AB680 and AB928 are different compounds. AB928 is also known as etrumadenant, and it was evaluated in a metastatic colorectal cancer study, NCT04660812. AB680 is a separate CD73-targeted small molecule developed by Arcus Biosciences.