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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07318805 | A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 260 | — | — | Dec 23, 2025 | Apr 14, 2030 | May 8, 2026 | 9 | United States |
Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.
Number of participants with laboratory test abnormalities.
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation Cohort 1A | EXPERIMENTAL | PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug |
| Part 1 Dose Escalation Cohort 1B | EXPERIMENTAL | Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug |
| Part 1 Dose Escalation Cohort 1C | EXPERIMENTAL | Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
| Part 1 Dose Escalation Cohort 1D | EXPERIMENTAL | Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
| Part 2 Dose Expansion Cohort 2A | EXPERIMENTAL | Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug |
| Part 2 Dose Expansion Cohort 2B | EXPERIMENTAL | PF-08032562 monotherapy or combination (PF-08032562 + cetuximab) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
| Part 2 Dose Expansion Cohort 2C | EXPERIMENTAL | Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug |
| Name | Type | Description |
|---|---|---|
| PF-08032562 | DRUG | Taken by mouth (PO) |
| Fulvestrant | DRUG | Selective Estrogen Receptor Degrader (SERD) |
| Cetuximab | DRUG | Monoclonal antibody (EGFR inhibitor) |
| Fluorouracil | DRUG | Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog) |
| Oxaliplatin | DRUG | Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent) |
| Leucovorin | DRUG | Part of FOLFOX chemotherapy regimen (folic acid analog) |
| Bevacizumab | DRUG | Monoclonal antibody (VEG-F inhibitor) |
Inclusion Criteria: * 18 years of age or older * Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1...