Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PF-4040
PF-07934040 · 1 trial · 3 indications
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...
PF-07934040 is an investigational small molecule being developed by Pfizer for the treatment of advanced solid tumors, including pancreatic ductal carcinoma. It is a targeted cancer therapy that is being studied in patients whose tumors have a specific genetic mutation. It is not yet approved for any indication.
PF-07934040 is being studied for use in patients with advanced solid tumors, including pancreatic ductal carcinoma, that harbor a genetic mutation. It is an investigational therapy and has not been approved for the treatment of pancreatic ductal carcinoma or any other cancer.
PF-07934040 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical trial evaluating this agent in advanced solid tumors with a genetic mutation.
PF-07934040 is in Phase 1 clinical development. The single ongoing trial is a Phase 1 study that is currently active but not recruiting participants. As a Phase 1 investigational agent, PF-07934040 has not received FDA approval for any indication.
PF-07934040 is being evaluated in one clinical trial, NCT06447662, titled 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. The trial is active but not recruiting, with an estimated enrollment of 64 participants.
The Phase 1 trial of PF-07934040, NCT06447662, is being conducted in the United States and Puerto Rico. It enrolls adults 18 years of age and older of all sexes and does not accept healthy volunteers. The study is controlled and biomarker-selected.