TerminatedPhase 1

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Stopped: Pfizer has made an internal business decision to not continue further development of PF-07265807. This decision was not due to major safety concerns or requests from any regulatory authorities.

United States, Canada, Italy88 participantsStarted 2020-09-24

Plain-language summary

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1 * ECOG Performance Status 0 or 1, 2 with approval * Adequate Bone Marrow Function * Adequate Renal Function * Adequate Liver Function * Resolved acute effects of any prior therapy * Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort). * Life expectancy of at least 3 months. * Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors. * Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available. * Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy. * Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy. * Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy. * Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before completing all its phases — do you know why it was stopped, and does that tell us anything important about the safety or effectiveness of PF-07265807 that I should be aware of?
2Since this was a Phase 1 trial focused on finding safe doses and identifying side effects rather than proving the treatment works, what does that mean for how much we actually know about whether this drug helps people with metastatic solid tumors?
3The trial was measuring dose-limiting toxicities and adverse events as its main goals — based on whatever data came out before it was terminated, were there any serious safety signals with PF-07265807 that would concern you if I were considering anything related to this drug?
4Given that this trial has been terminated, are there other active trials or approved treatments for my specific type of metastatic cancer that you think would be a better path to explore right now?
5If the termination of this study was related to problems with the drug itself rather than administrative reasons, how should that factor into our conversations about similar experimental treatments I might come across?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)

Timeframe: Baseline through day 21 or 42

Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)

Timeframe: Baseline through approximately 2 years

Parts 1, 2, and 3: Number of participants with laboratory abnormalities

Timeframe: Baseline through approximately 2 years

Part 4: Overall Response Rate (ORR)

Timeframe: Baseline through approximately 2 years

Part 4, Cohort 4: Complete Response (CR)

Timeframe: Baseline through approximately 2 years

Trial details

NCT IDNCT04458259

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

View on ClinicalTrials.gov More Neoplasm Metastasis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)

Timeframe: Baseline through day 21 or 42

Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)

Timeframe: Baseline through approximately 2 years

Parts 1, 2, and 3: Number of participants with laboratory abnormalities

Timeframe: Baseline through approximately 2 years

Part 4: Overall Response Rate (ORR)

Timeframe: Baseline through approximately 2 years

Part 4, Cohort 4: Complete Response (CR)

Timeframe: Baseline through approximately 2 years