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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-07985045 is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1 Dose Escalation
PF-07985045 monotherapy Dose Escalation at prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 1 Cohort A1
PF-07985045 monotherapy dose expansion in 2-3L PDAC at prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 1 Cohort B1
PF-07985045 monotherapy dose expansion in 2-3L CRC at prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 1 Cohort C1
PF-07985045 monotherapy dose expansion in 2-3L NSCLC at prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 1 Cohort D1
PF-07985045 monotherapy dose expansion in other tumor types at prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort A2
Combination (PF-07985045 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort B2
Combination (PF-07985045 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort B3
Combination (PF-07985045 + FOLFOX + Bevacizumab) dose escalation/ expansion in 1L CRC Prescribed dose and frequency in 28-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort C2
Combination (PF-07985045 + Pembro or sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day (pembro) or 28-day (sasanlimab) cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort C3
Combination (PF-07985045 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles
DRUG: PF-07985045
KRAS inhibitor
EXPERIMENTAL: Part 2 Cohort X
Combination (PF-07985045 + SHP2) dose escalation/expansion Prescribed dose and frequency in 21-day cycles
DRUG: PF-07985045
KRAS inhibitor
Part 1 & 2: Incidence of Adverse Events (AEs)
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.
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
PART 1 & 2: Number of participants with laboratory abnormalities
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).
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 1 & Part 2 (Dose Escalation Only): Number of participants with Dose-limiting toxicities (DLT)
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
Baseline up to 28 days
Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)
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) assessed by the Investigator.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)
Evaluate the single and multiple dose PK ofPF-07985045 as monotherapy, or in combination with other anti-tumor agents.
baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 which are 21 days)
Part 1& 2: Time to Reach Maximum Observed Serum Concentration (Tmax)
Evaluate the single and multiple dose PK of PF-07985045 as monotherapy, or in combination with other anti-tumor agents.
Baseline through end of Cycle 1 (All cycles are 28 days except part 2 Cohort C2/C3 which are 21 days)
Part 1 & 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Evaluate the single and multiple dose PK of PF-07985045 as monotherapy, or in combination with other anti-tumor agents.
Baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 which are 21 days)
Part 1 & 2: Changes in pERK levels
Evaluates the intended mechanism of action (MoA) modulation of KRAS inhibition and target engagement effect of PF-07985045 in peripheral blood of participants with advanced solid tumor malignancies.
Baseline through end of Cycle 1 (All cycles are 28 days except Part 2 Cohort C2/C3 which are 21 days)
Objective Response - Number of Participants With Objective Response
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) assessed by the Investigator including overall response rate (ORR) (Part 1 only), progression free survival (PFS), and duration of response (DOR).
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
Part 1: Effect of Food on Cmax
Evaluate the effect of food on Cmax of PF-07985045 as monotherapy.
Baseline through end of Cycle 1 (All cycles are 28 days)
Part 1: Effect of Food on Tmax
Evaluate the effect of food on Tmax of PF-07985045 as monotherapy.
Baseline through end of Cycle 1 (All cycles are 28 days)
Part 1: Effect of Food on AUClast
Evaluate the effect of food on AUClast of PF-07985045 as monotherapy.
Baseline through end of Cycle 1 (All cycles are 28 days)
190
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: