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. (NCT06447662)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose. This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that: * are advanced (cancer that doesn't disappear or stay away with treatment) and * have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers). This includes (but limited to) the following cancer types: Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control. Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels. All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles. Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle. Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (16 items) and avoid the listed exclusions (11 items).
Location: Highlands Oncology Group, PA — Fayetteville, Arkansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (27 Sites)
- Highlands Oncology Group, PA — Fayetteville, Arkansas
- Highlands Oncology Group, PA — Rogers, Arkansas
- Highlands Oncology Group — Springdale, Arkansas
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California
- City of Hope Investigational Drug Service (IDS) — Duarte, California
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado
- University of Colorado Hospital - Anschutz Outpatient Pavilion — Aurora, Colorado
- University of Colorado Hospital- Anschutz Cancer Pavilion (ACP) — Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- START Midwest — Grand Rapids, Michigan
- Siteman Cancer Center - St Peters — City of Saint Peters, Missouri
- Siteman Cancer Center - West County — Creve Coeur, Missouri
- Siteman Cancer Center - North County — Florissant, Missouri
- Siteman Cancer Center — St Louis, Missouri
- Barnes-Jewish Hospital — St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center - South County — St Louis, Missouri
- Duke University Medical Center, lnvestigational Chemotherapy Service — Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina
- University of Cincinnati Medical Center — Cincinnati, Ohio
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio
- West Chester Hospital — West Chester, Ohio
- Rhode Island Hospital — Providence, Rhode Island
- Miriam Hospital — Providence, Rhode Island
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.