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 being studied for use in healthy volunteers and in oncology indications including metastatic colorectal cancer and advanced pancreatic cancer. It is being developed by Arcus Biosciences, Inc. (RCUS) and is currently in Phase 1 clinical development.
AB680 targets CD73, a protein involved in the production of adenosine in the tumor microenvironment. By inhibiting CD73, AB680 is designed to modulate the immune response against tumors. This mechanism is being evaluated in early-stage clinical trials for gastrointestinal malignancies.
AB680 is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the NYSE under the ticker RCUS. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of AB680 in healthy volunteers and in patients with certain cancers.
AB680 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety, tolerability, and pharmacokinetic profile in healthy volunteers and in patients with gastrointestinal malignancies.
AB680 has been studied in several Phase 1 trials. NCT03677973 and NCT04575311 evaluated safety and pharmacokinetics in healthy volunteers in Australia. NCT04104672 assessed safety and tolerability in advanced pancreatic cancer in the United States. NCT04660812 evaluated AB680 in combination with etrumadenant in metastatic colorectal cancer across multiple countries.
No, AB680 is not the same as etrumadenant. AB680 is a CD73 inhibitor, while etrumadenant (AB928) is a separate investigational drug. In clinical trial NCT04660812, AB680 was studied in combination with etrumadenant for the treatment of metastatic colorectal cancer.