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Early trial of experimental cancer combo halted after 21 patients

NCT ID NCT05233436

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Feb 2022

Finished

Oct 2023

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • HonorHealth Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85260, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229, United States

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550, Japan

  • University of Iowa

    Iowa City, Iowa, 52242, United States

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