New pill takes on KRAS-Mutant cancers in early trial

NCT ID NCT06447662

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 23, 2026 · Updated 4 times

Summary

This early-stage study tests a new experimental drug called PF-07934040, taken as a pill, for people with advanced solid tumors that have a KRAS gene mutation. The trial includes patients with non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Researchers will give the drug alone or combined with other cancer treatments to find the safest dose and see if it helps control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: PF-07934040 (a pan-KRAS inhibitor pill)
What this could lead to: If successful, this could lead to a new treatment option for people with advanced cancers driven by KRAS mutations, including lung, colorectal, and pancreatic cancers.
What could go wrong: This is an early Phase 1 trial focused on safety and dosing, not yet proven to work. Side effects are unknown, and the drug may not shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 KRAS gene 1. PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant 2. NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. If driver mutation, must have failed precision medicine therapy \[eg, inhibitors of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), and others\]. * Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for which no additional, effective therapy is available. 1. PDAC (2-3L): Participants must have received and radiologically progressed on prior lines of systemic therapy for metastatic pancreatic adenocarcinoma. If participants received prior neoadjuvant or adjuvant chemotherapy and progressed within 6 months of the last dose, then this should be considered as a prior line of systemic therapy. 2. NSCLC (2-3L): Participants must have received prior lines of anti-cancer treatment and progressed on at least a platinum-containing chemotherapy regimen or ICI. Participants may have had only one or two prior lines of therapy in the advanced/metastatic setting. For participants with EGFR, ALK, or other genomic tumor alterations, participants must have progressed on approved therapy for these alterations. 3. CRC (2-3L): Participants must have had one or two prior lines of therapy for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, and/or irinotecan for one prior treatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional; 4. Other tumors: Participants, in the judgment of the investigator, must have progressed or become intolerant to all available standard therapies, or have refused such therapy. * Part 2b: 1. PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy for metastatic disease. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant treatment or neoadjuvant therapy, the participant would be considered 2L, and not 1L. 2. CRC (2-3L) Cohort B2: Participants must have had one or two prior systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; for one prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional. 3. CRC (1L) Cohort B3/B4: Participants must not have received prior therapy for metastatic disease and not be a candidate for other targeted therapy or immunotherapy. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant or neoadjuvant therapy, then the participant would be considered 2L, and not 1L. 4. NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting. 5. NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior systemic treatment setting. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm lung neoplasm neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung Carcinoma, pancreatic ductal Colorectal neoplasms

Contacts and locations

Locations

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States
City of Hope Investigational Drug Service (IDS)

Duarte, California, 91010, United States
Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Duke University Medical Center, lnvestigational Chemotherapy Service

Durham, North Carolina, 27710, United States
Highlands Oncology Group

Springdale, Arkansas, 72762, United States
Highlands Oncology Group, PA

Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA

Rogers, Arkansas, 72758, United States
Miriam Hospital

Providence, Rhode Island, 02906, United States
Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
START Midwest

Grand Rapids, Michigan, 49546, United States
Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States
Siteman Cancer Center

St Louis, Missouri, 63108, United States
Siteman Cancer Center - North County

Florissant, Missouri, 63031, United States
Siteman Cancer Center - South County

St Louis, Missouri, 63129, United States
Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States
University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States
University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045, United States
University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Chester Hospital

West Chester, Ohio, 45069, United States

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