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Study of PF-07934040 for Advanced Solid Tumors with KRAS Mutation

This study is looking into the safety and effects of a medicine called PF-07934040, either alone or combined with other cancer treatments like Gemcitabine, Nab-paclitaxel, Cetuximab, or Fluorouracil. It's for people with advanced (cancer that doesn't disappear or stay away with treatment) solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that have a specific change in their DNA called a KRAS gene mutation. This includes certain types of pancreatic, colorectal, and non-small cell lung cancer. The main goal is to find out how safe these treatments are and to determine the best dose. Researchers will be looking at side effects and changes in lab tests.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 64 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor side effects and lab abnormalities from the start of treatment up to 30 days after the last dose or the start of new anticancer therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~64 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:PF-07934040GemcitabineNab-paclitaxelCetuximabFluorouracilOxaliplatin

At a glance

Recruiting sites
0 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 & 2: Incidence of Adverse Events (AEs)
Measured over Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
+3 more outcomes measured

Conditions

Carcinoma, Pancreatic Ductal
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

27 sites across 11 states
Missouri7
Colorado4
Arkansas3
Ohio3
California2
North Carolina2
Rhode Island2
District of Columbia1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.
Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been previously irradiated.
Documentation of mutated KRAS gene
Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for which no additional, effective therapy is available.
Part 2b:

Exclusion

Active or history of pneumonitis/ILD or pulmonary fibrosis requiring treatment with systemic steroid therapy.
Diagnosis of immunodeficiency or an active autoimmune disease that require systemic treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy in the past 2 years.
Sensory peripheral neuropathy ≥Grade 2
Active or history of clinically significant gastrointestinal (GI) disease (including but not limited to inflammatory GI disease \[eg, ulcerative colitis, Crohn's disease, inflammatory bowel disease\], immune-mediated colitis, peptic ulcer disease, GI bleeding, chronic diarrhea) and other conditions that are unresolved and/or may increase the risk associated with study participation or study treatment administration.
Active bleeding disorder, including GI bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months.
Major surgery or completion of radiation therapy ≤4 weeks prior to enrollment/randomization or radiation therapy that included \>30% of the bone marrow.
Known sensitivity or contraindication to any component of study intervention (PF 07934040, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s), cyclin-dependent kinase (CDK) inhibitor(s), antibody drug conjugates (ADCs) or EGFR inhibitor(s)).
Hematologic abnormalities.
Renal impairment.
Hepatic abnormalities.

What this trial measures

  • Part 1 & 2: Incidence of Adverse Events (AEs)Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

    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.

  • PART 1 & 2: Number of participants with laboratory abnormalitiesFrom start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

    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).

  • Part 1: Number of participants with Dose-limiting toxicities (DLT)Baseline up to 28 days

    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

  • Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

    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.