Early trial of experimental cancer combo halted after 21 patients
NCT ID NCT05233436
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested an experimental oral drug (PF-07265028) alone or combined with an immunotherapy injection (sasanlimab) in 21 people with advanced solid tumors, including stomach, lung, and head/neck cancers. The main goals were to find a safe dose and check for side effects. The trial was terminated early, so results are limited and no conclusions about effectiveness can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-07265028 (oral drug) and sasanlimab (injectable immunotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for several advanced cancers, potentially shrinking tumors or slowing their growth.
- What could go wrong
- This is a very early Phase 1 trial with only 21 participants, now terminated. It was designed mainly to check safety and dosing, not to prove effectiveness. Many early cancer drugs fail to show benefit in larger studies.
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
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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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21 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Oct 2023
- 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 to 99 years
- 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.
Key Inclusion Criteria: Across all cohorts: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 2. Adequate hematological, kidney and liver function 3. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 4. Resolved acute effects of any prior therapy 5. All participants must provide archival formalin-fixed paraffin-embedded (FFPE) tumor tissue: Part 1: If archival sample is older than 6 months, the participant must consent to undergo a fresh biopsy during the screening. Part 2 Fresh tumor biopsy during screening is required unless there is archival tissues less than 3 months old and subsequent to the last systemic anti-cancer therapy. Part 1A Monotherapy: Histologically or cytologically confirmed advanced or metastatic solid tumors which have progressed following systemic anticancer therapies, or are resistant to standard therapy or for which no standard therapy is available, or for whom standard therapy is not tolerated. Part 1B Combination Therapy: Histologically or cytologically confirmed advanced or metastatic solid tumor which have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor. Part 2 Dose Expansion: Histologically or cytologically confirmed advanced or metastatic malignancies, including gastric/Gastroesophageal junction cancer, Head and neck squamous cell carcinoma, or urothelial cancer (non-small cell lung cancer and other solid tumors may be included) who have progressed following systemic anticancer therapies, including at least 1 checkpoint inhibitor Key Exclusion Criteria: 1. Participants with any other active malignancy within 3 years prior to enrollment 2. Participants with active autoimmune conditions or history of autoimmune diseases that may relapse 3. History of interstitial lung disease, pneumonitis (non-infectious) or uncontrolled lung diseases 4. History of prior immune-related adverse events (irAEs) Grade ≥3 5. Central nervous system metastases 6. Significant cardiac or pulmonary conditions or events within previous 6 months 7. Active, uncontrolled bacterial, fungal, or viral infection 8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PF-07265028 9. Prior administration of HPK1 inhibitor
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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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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260, United States
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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
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START Midwest
Grand Rapids, Michigan, 49546, United States
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South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
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The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550, Japan
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University of Iowa
Iowa City, Iowa, 52242, United States
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Other studies related to the condition(s) this trial covers.
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