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NCT06447662 | RECRUITING | Carcinoma, Pancreatic Ductal

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.
Sponsor:

Pfizer

Brief Summary:

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.

Condition or disease

Carcinoma, Pancreatic Ductal

Colorectal Neoplasms

Carcinoma, Non-Small-Cell Lung

Intervention/treatment

PF-07934040

Gemcitabine

Nab-paclitaxel

Cetuximab

Fluorouracil

Oxaliplatin

Leucovorin

Bevacizumab

Pembrolizumab

pemetrexed

Cisplatin

Paclitaxel

Carboplatin

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 330 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene
Actual Study Start Date : 2024-06-27
Estimated Primary Completion Date : 2027-09-24
Estimated Study Completion Date : 2028-09-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 and checkpoint inhibitor therapy; 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 systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, 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, as long as relapse did not occur within 6 months of completing these forms of adjuvant treatment. If so, the relapse within 6 months would be considered a line of 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: Participants must not have had prior chemotherapy for advanced or metastatic disease. Participant could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy, as long as relapse did not occur within 6 months of complete of adjuvant therapy. If so, the relapse within 6 months would be considered a line of therapy; 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, pulmonary fibrosis requiring treatment with systemic steroid therapy, including evidence to suggest pneumonitis/ILD on baseline assessments including imaging.
    • * 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.
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.

Location Details

NCT06447662

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arkansa

Highlands Oncology Group, PA

Fayetteville, Arkansa, United States, 72703

RECRUITING

United States, Arkansa

Highlands Oncology Group, PA

Rogers, Arkansa, United States, 72758

RECRUITING

United States, Arkansa

Highlands Oncology Group

Springdale, Arkansa, United States, 72762

RECRUITING

United States, California

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States, 91010

RECRUITING

United States, California

City of Hope Investigational Drug Service (IDS)

Duarte, California, United States, 91010

RECRUITING

United States, Colorado

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States, 80045

RECRUITING

United States, Colorado

University of Colorado Hospital - Anschutz Outpatient Pavilion

Aurora, Colorado, United States, 80045

RECRUITING

United States, Colorado

University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States, 80045

RECRUITING

United States, Colorado

University of Colorado Hospital

Aurora, Colorado, United States, 80045

RECRUITING

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, Missouri

Siteman Cancer Center - West County

Shrimp, Missouri, United States, 63141

RECRUITING

United States, Missouri

Siteman Cancer Center - North County

Florissant, Missouri, United States, 63031

RECRUITING

United States, Missouri

Siteman Cancer Center

Saint Louis, Missouri, United States, 63108

RECRUITING

United States, Missouri

Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Missouri

Siteman Cancer Center - South County

Saint Louis, Missouri, United States, 63129

RECRUITING

United States, Missouri

Siteman Cancer Center - St Peters

Saint Peters, Missouri, United States, 63376

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

RECRUITING

United States, Ohio

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

West Chester Hospital

West Chester, Ohio, United States, 45069

RECRUITING

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

RECRUITING

United States, Rhode Island

Miriam Hospital

Providence, Rhode Island, United States, 02906

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

Puerto Rico,

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico, 00935