Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06015659 | ZN-c3 + Gemcitabine in Pancreatic Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 12 | — | — | Nov 16, 2023 | Jun 1, 2027 | May 4, 2026 | 1 | United States |
6-month PFS rate is the proportion of participants remaining alive and progression free at 6 months. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
| Arm | Type | Description |
|---|---|---|
| ZN-c3 + Gemcitabine | EXPERIMENTAL | Study procedures will be conducted as follows: * Cycle 1 - End of Treatment * Days 1 - 5 of 21-day cycle: Predetermined dose of ZN-c3 1x daily. * Days 8 - 12 of 21-day cycle: Predetermined dose of ZN-c3 1x daily. * Days 15 - 19 of 21-day cycle: Predetermined dose of ZN-c3 1x daily. * Day 1 and 8 of 21-day cycle: Predetermined dose of Gemcitabine 1x daily. * On-treatment tumor biopsy will be collected on either Cycle 1 Day 9 - 10 or Cycle 2 Day 9 - 10. * Tumor assessment by Computerized Tomography (CT) or Magnetic Resonance Imaging scan every 8 weeks while on treatment. * End of treatment visit with tumor assessment by CT or MRI and optional tumor biopsy. * Follow up visit every 2 months after treatment has ended. |
| Name | Type | Description |
|---|---|---|
| Zentalis | DRUG | Small molecule inhibitor of the WEE1 tyrosine kinase, tablet taken orally per protocol. |
| Gemzar | DRUG | Nucleoside metabolic inhibitor, per standard care via intravenous infusion. |
Inclusion Criteria: * Participants must have a pathologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches based on the judgement of the treating investigator. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible. * ...