Pfizer's new cancer pill tested in advanced tumors – study halted early
NCT ID NCT06704724
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new cancer pill (PF-07985045) alone or with other drugs in people with advanced solid tumors that have a KRAS gene mutation. The trial included patients with lung, colon, or pancreatic cancer. The study aimed to check safety and find the right dose, but it was terminated early. Participants took the pill in 21- or 28-day cycles and could continue until their cancer stopped responding.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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May 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. * Note for PDAC: Only participants with the histologic type of adenocarcinoma of the pancreas are allowed to enroll. For PDAC, if loco-regional disease is present, must also have metastatic disease. * Note for NSCLC: If a driver mutation is present, the participant was resistant or intolerant of precision medicine therapy (eg, inhibitors of EGFR, ALK, ROS1, or others). * 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 a. KRAS mutations of any variant except previously treated with any KRAS inhibitor * Part 1: 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/or 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 only 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 2: 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 pneumonitis/ILD, pulmonary fibrosis requiring treatment with systemic steroid therapy. Additionally, participants in IO combinations (Cohorts C2 and C3) with history and/or active pneumonitis/ILD or pulmonary fibrosis requiring steroids are excluded from enrollment. * 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. * Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including drainage catheter placement, therapeutic thoracentesis or abdominal paracentesis) is eligible. * Current use or have received PPIs in the last seven days prior to starting study treatment. * Known sensitivity or contraindication to any component of study intervention (PF-07985045, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, sasanlimab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s). * Hematologic abnormalities. * Renal impairment. * Hepatic abnormalities.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte, California, 91010, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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DFCI Chestnut Hill
Newton, Massachusetts, 02467, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
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Highlands Oncology Group
Rogers, Arkansas, 72758, United States
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Highlands Oncology Group
Springdale, Arkansas, 72762, United States
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Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
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The Trustees of Columbia University and The New York and Presbyterian Hospital
New York, New York, 10032, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
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University of Wisconsin Carbone Cancer Center-University Hospital
Madison, Wisconsin, 53792, United States
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