Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quemliclustat · 3 trials · 3 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.
| 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. |
| Quemliclustat | EXPERIMENTAL | Participants will receive a single dose of \[14C\]-quemliclustat through IV infusion. |
| 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 |
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...