TerminatedPhase 1

A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer

Stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns

United States4 participantsStarted 2024-11-11

Plain-language summary

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body. This study is seeking participants who have any of the following cancer types: * non-small cell lung cancer * colorectal cancer * bladder cancer * melanoma (a type of skin cancer) * kidney cancer * head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic. PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks. The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Participants aged ≥18 years or older at the time of informed consent.
✓. Tumor types and prior treatment requirements: Participants entering Parts 2 and 3 must have at least 1 measurable lesion.
✓. ECOG PS 0 or 1.

Exclusion criteria

✕. Participants with any other active malignancy within 3 years prior to enrollment.
✕. Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
✕. History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
✕. History of venous thromboembolic event \<12 weeks prior to starting study treatment.
✕. Active or history of clinically significant gastrointestinal (GI) disease.
✕. Active or history of interstitial lung disease or Grade ≥2 pneumonitis.

What they're measuring

Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)

Timeframe: Baseline up to Cycle 2 (each cycle is 21 days)

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)

Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)

Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Objective Response Rate - Percentage of Participants With Objective Response (Part 3)

Timeframe: Date of first dose up to 2 years

Trial details

NCT IDNCT06580938

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-14

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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

✓. Participants aged ≥18 years or older at the time of informed consent.
✓. Tumor types and prior treatment requirements: Participants entering Parts 2 and 3 must have at least 1 measurable lesion.
✓. ECOG PS 0 or 1.

Exclusion criteria

✕. Participants with any other active malignancy within 3 years prior to enrollment.
✕. Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
✕. History of Grade ≥3 immune-related AE (irAE) or unresolved irAEs prior to first dose of study intervention. Exception: vitiligo and endocrinopathy that is controlled with hormonal therapy.
✕. History of venous thromboembolic event \<12 weeks prior to starting study treatment.
✕. Active or history of clinically significant gastrointestinal (GI) disease.
✕. Active or history of interstitial lung disease or Grade ≥2 pneumonitis.

What they're measuring

Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)

Timeframe: Baseline up to Cycle 2 (each cycle is 21 days)

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)

Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)

Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Objective Response Rate - Percentage of Participants With Objective Response (Part 3)

Timeframe: Date of first dose up to 2 years