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

Introduction

• Org Study ID: C5461001
• NTC ID: NCT06580938
• Lead Sponsor Name: Pfizer
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief 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.

Eligibility Criteria

Key Inclusion Criteria:

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

Part 1 and Part 2:

Eligible advanced/metastatic tumor types include NSCLC, urothelial carcinoma (UC), renal cell carcinoma (RCC), melanoma, head and neck squamous cell carcinoma (HNSCC), and microsatellite stable colorectal cancer (MSS-CRC). Participants must have demonstrated radiographic progression on standard treatment(s) for their cancer

Part 3:
* Cohort 1: Participants with metastatic melanoma with resistance to checkpoint inhibitor therapy and BRAF/MEKi.
* Cohort 2: Participants with metastatic MSS-CRC.
* Cohort 3: Participants with previously untreated metastatic NSCLC.
3. ECOG PS 0 or 1.

Key Exclusion Criteria:

1. Participants with any other active malignancy within 3 years prior to enrollment.
2. Known or suspected hypersensitivity to, or severe allergic history of, human albumin or anti-PD-(L)1 therapy.
3. 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.
4. History of venous thromboembolic event