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Also known as AB680
Quemliclustat · 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...
Quemliclustat is an investigational small molecule being studied in oncology, specifically for metastatic pancreatic ductal adenocarcinoma and oligometastatic prostate cancer. It is not yet approved for any indication and remains in clinical development under Arcus Biosciences.
Quemliclustat targets CD73, an enzyme that generates adenosine in the tumor microenvironment. By inhibiting CD73, the drug aims to reduce adenosine-mediated immune suppression and support antitumor immune responses. It belongs to the -stat class of enzyme inhibitors.
Quemliclustat is being developed by Arcus Biosciences, Inc., which trades on the New York Stock Exchange under the ticker RCUS. The company is the sponsor of the clinical trials evaluating the drug in pancreatic and prostate cancers.
Quemliclustat is in Phase 3 clinical development. The Phase 3 trial is evaluating the drug in metastatic pancreatic ductal adenocarcinoma, while a Phase 2 trial is studying it in oligometastatic prostate cancer. It is investigational and has not been approved by the FDA.
Quemliclustat is being evaluated in two registered trials. NCT06608927 is a Phase 3, randomized, double-blind, placebo-controlled study in metastatic pancreatic ductal adenocarcinoma with 610 patients. NCT05915442 is a Phase 2 recruiting study in oligometastatic prostate cancer with 23 patients.
No, quemliclustat is not FDA approved. It is an investigational drug still in clinical development, currently in Phase 3 testing for metastatic pancreatic ductal adenocarcinoma and Phase 2 testing for oligometastatic prostate cancer.