Phase
Condition
Carcinoma
Neoplasms
Treatment
Gemcitabine
Nab-paclitaxel
Fluorouracil
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histological or cytological diagnosis of advanced, unresectable, and/or metastaticor relapsed/refractory solid tumor.
ECOG PS 0 or 1
Presence of at least 1 measurable lesion based on RECIST version 1.1 that has notbeen previously irradiated.
Documentation of mutated KRAS gene
PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. Ifdriver mutation, must have failed precision medicine therapy [eg, inhibitors ofepidermal 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) forwhich no additional, effective therapy is available.
PDAC (2-3L): Participants must have received and radiologically progressed onprior lines of systemic therapy for metastatic pancreatic adenocarcinoma. Ifparticipants received prior neoadjuvant or adjuvant chemotherapy and progressedwithin 6 months of the last dose, then this should be considered as a priorline of systemic therapy.
NSCLC (2-3L): Participants must have received prior lines of anti-cancertreatment and progressed on at least a platinum-containing chemotherapy regimenand checkpoint inhibitor therapy; for participants with EGFR, ALK, or othergenomic tumor alterations, participants must have progressed on approvedtherapy for these alterations.
CRC (2-3L): Participants must have had one or two prior systemic treatmentregimens for mCRC. For either one or two prior treatments, these regimens musthave included a fluoropyrimidine, oxaliplatin, or irinotecan; for one priortreatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional;
Other tumors: Participants, in the judgment of the investigator, must haveprogressed or become intolerant to all available standard therapies, or haverefused such therapy.
- Part 2b:
PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy formetastatic disease. Participant could have received neoadjuvant therapy,adjuvant therapy, or adjuvant chemo-radiotherapy, as long as relapse did notoccur within 6 months of completing these forms of adjuvant treatment. If so,the relapse within 6 months would be considered a line of therapy; theparticipant would be considered 2L, and not 1L.
CRC (2-3L) Cohort B2: Participants must have had one or two prior systemictreatment regimens for mCRC. For either one or two prior treatments, theseregimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; forone prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor isoptional.
CRC (1L) Cohort B3: Participants must not have had prior chemotherapy foradvanced or metastatic disease. Participant could have received adjuvantchemotherapy or adjuvant chemo-radiotherapy, as long as relapse did not occurwithin 6 months of complete of adjuvant therapy. If so, the relapse within 6months would be considered a line of therapy; the participant would beconsidered 2L, and not 1L.
NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not havereceived prior systemic treatment setting.
NSCLC (1L) Cohort C3: Participants with any TPS and must not have receivedprior systemic treatment setting.
Exclusion
Exclusion Criteria:
Active or history of pneumonitis/ILD, pulmonary fibrosis requiring treatment withsystemic steroid therapy, including evidence to suggest pneumonitis/ILD on baselineassessments including imaging.
Diagnosis of immunodeficiency or an active autoimmune disease that require systemictreatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily ofprednisone equivalent) or any other form of immunosuppressive therapy in the past 2years.
Sensory peripheral neuropathy ≥Grade 2
Active or history of clinically significant gastrointestinal (GI) disease (includingbut not limited to inflammatory GI disease [eg, ulcerative colitis, Crohn's disease,inflammatory bowel disease], immune-mediated colitis, peptic ulcer disease, GIbleeding, chronic diarrhea) and other conditions that are unresolved and/or mayincrease the risk associated with study participation or study treatmentadministration.
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 toenrollment/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 EGFRinhibitor(s)).
Hematologic abnormalities.
Renal impairment.
Hepatic abnormalities.
Study Design
Connect with a study center
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
Puerto RicoActive - Recruiting
Highlands Oncology Group, PA
Fayetteville, Arkansas 72703
United StatesActive - Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas 72758
United StatesActive - Recruiting
Highlands Oncology Group
Springdale, Arkansas 72762
United StatesActive - Recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Investigational Drug Service (IDS)
Duarte, California 91010
United StatesActive - Recruiting
University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
Aurora, Colorado 80045
United StatesActive - Recruiting
START Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
United StatesActive - Recruiting
Siteman Cancer Center - North County
Florissant, Missouri 63031
United StatesActive - Recruiting
Barnes-Jewish Hospital
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Siteman Cancer Center
Saint Louis, Missouri 63108
United StatesActive - Recruiting
Siteman Cancer Center - South County
Saint Louis, Missouri 63129
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Siteman Cancer Center - St Peters
Saint Peters, Missouri 63376
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United StatesActive - Recruiting
West Chester Hospital
West Chester, Ohio 45069
United StatesActive - Recruiting
Miriam Hospital
Providence, Rhode Island 02906
United StatesActive - Recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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