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Also known as Quemliclustat, CD73 Inhibitor AB680
AB680 · 4 trials · 4 indications
Biochemical recurrence is defined as a 0.2 ng/ml increase in PSA above the post-SBRT PSA nadir. Patient will be followed until biochemical recurrence, death, or end of study, whichever comes first. Patients who are alive and biochemical recurrence free will be censored at the last PSA measurement date.
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
Safety will be assessed by monitoring adverse events and clinically relevant changes in 12 lead Electrocardiogram (ECG) and Physical examination findings
| Arm | Type | Description |
|---|---|---|
| Arm A (Experimental Arm) | EXPERIMENTAL | Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion |
| Arm B (Comparator Arm) | PLACEBO_COMPARATOR | Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion |
| Treatment with quemliclustatm, etrumadenant, zimberelimab and SBRT | EXPERIMENTAL | Subjects with metastatic prostate cancer will receive quemliclustat and etrumadenant for 4 weeks prior to metastasis-directed SBRT (Stereotactic Body Radiation Therapy). Within one week of completing SBRT, subjects will also start zimberelimab. |
| 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. |
| 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 |
|---|---|---|
| Quemliclustat | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Administered as specified in the treatment arm |
| Nab-paclitaxel | DRUG | Administered as specified in the treatment arm |
| Gemcitabine | DRUG | Administered as specified in the treatment arm |
| Etrumadenant | DRUG | 150 mg orally (PO) once a day (QD) |
| Zimberelimab | DRUG | 240 mg IV once every two weeks starting within 1 week of completing metastasis-directed SBRT |
| Stereotactic Body Radiation Therapy | RADIATION | Standard of care metastasis-directed hypofractionated radiotherapy treatment starting 4 weeks (+/- 1 week) of starting Etrumadenant and Quemliclustat |
| AB680 | DRUG | AB680 is a cluster of differentiated CD73 Inhibitor |
| 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 |
Inclusion Criteria: * Have histologically or cytologically confirmed PDAC that is metastatic. * Have not been previously treated for PDAC in the metastatic setting. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. 2. Prior...
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AB680 is an investigational small molecule developed by Arcus Biosciences, Inc. (ticker RCUS). It is being studied in oncology for advanced pancreatic cancer and metastatic colorectal cancer. AB680 is in Phase 1 clinical development and has not been approved by the FDA.
AB680 targets CD73, a protein. By inhibiting CD73, AB680 is designed to modulate adenosine signaling in the tumor microenvironment. This mechanism is being explored in advanced pancreatic cancer and metastatic colorectal cancer.
AB680 is being developed by Arcus Biosciences, Inc., which trades under the ticker RCUS. The company is responsible for the clinical development of AB680 in advanced pancreatic cancer and metastatic colorectal cancer.
AB680 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program includes completed trials in advanced pancreatic cancer and metastatic colorectal cancer.
AB680 has been evaluated in two completed Phase 1 trials. NCT04104672 studied AB680 in participants with gastrointestinal malignancies, including advanced pancreatic cancer, in the United States. NCT04660812 studied AB680-based treatment combinations in metastatic colorectal cancer across the United States, France, Italy, South Korea, Spain, and the United Kingdom.