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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06447662 | A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation. | PHASE1 | RECRUITING | 330 | — | — | Jun 27, 2024 | Jan 18, 2029 | Apr 20, 2026 | 28 | United States, China +1 |
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. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.
Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).
Any of the prespecified AEs 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
Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for overall response rate (ORR), progression free survival (PFS), and overall survivor (OS) assessed by the Investigator.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles |
| Part 2a Cohort A1 | EXPERIMENTAL | Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
| Part 2a Cohort B1 | EXPERIMENTAL | Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
| Part 2a Cohort C1 | EXPERIMENTAL | Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles |
| Part 2a Cohort D1 | EXPERIMENTAL | Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles |
| Part 2b Cohort A2 | EXPERIMENTAL | Combination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles |
| Part 2b Cohort B2 | EXPERIMENTAL | Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles |
| Part 2b Cohort B3 | EXPERIMENTAL | Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles |
| Part 2b Cohort B4 | EXPERIMENTAL | Combination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles |
| Part 2b Cohort C2 | EXPERIMENTAL | Combination (PF-07934040 + Pembro or Sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day cycles (for pembro) or 28-day cycles (for sasanlimab) |
| Part 2b Cohort C3 | EXPERIMENTAL | Combination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles |
| Name | Type | Description |
|---|---|---|
| PF-07934040 | DRUG | panKRAS inhibitor |
| Gemcitabine | COMBINATION_PRODUCT | Chemotherapy (antimetabolite) |
| Nab-paclitaxel | COMBINATION_PRODUCT | Taxane-type Chemotherapy |
| Cetuximab | COMBINATION_PRODUCT | Monoclonal Antibody (EGFR Inhibitor) |
| Fluorouracil | COMBINATION_PRODUCT | Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog) |
| Oxaliplatin | COMBINATION_PRODUCT | Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent) |
| Leucovorin | COMBINATION_PRODUCT | Part of FOLFOX chemotherapy regimen Folic Acid Analog |
| Bevacizumab | COMBINATION_PRODUCT | VEG-F inhibitor |
| Pembrolizumab | COMBINATION_PRODUCT | immune checkpoint inhibitor (PD-1 inhibitor) |
| pemetrexed | COMBINATION_PRODUCT | Can be used in Platinum-based Chemotherapy regimen Antimetabolite |
| Cisplatin | COMBINATION_PRODUCT | Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent) |
| Paclitaxel | COMBINATION_PRODUCT | Can be used in Platinum-based chemotherapy regimen Taxane |
| Carboplatin | COMBINATION_PRODUCT | Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent) |
| Sasanlimab | COMBINATION_PRODUCT | immune checkpoint inhibitor (PD-1 inhibitor) |
Inclusion Criteria: * Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor. ECOG PS 0 or 1 * Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been previously irradiated. * Documentation of mutated KR...