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Brief Title: PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF PF-07921585 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH ADVANCED SOLID TUMORS

INTRODUCTION

  • Org Study ID: C5461001
  • Secondary ID: N/A
  • NCT ID: NCT06580938
  • Sponsor: Pfizer

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.

DETAILED DESCRIPTION

The study contains 3 parts:

Part 1: dose escalation of PF-07921585 as single agent to determine the monotherapy recommended dose for further study.

Part 2: dose escalation of PF-07921585 in combination with the anti-PD 1 inhibitor sasanlimab and potentially other anti-cancer agents, in order to determine the recommended dose for expansion of the combination.

Part 3: dose optimization/ expansion will evaluate PF-07921585 in combination with sasanlimab, and potentially other anti-cancer agents. After identification of the recommended dose for expansion in Part 2, participants with select solid tumors will be enrolled into 3-4 cohorts as follows:

* Cohort 1: Melanoma
* Cohort 2: Microsatellite stable (MSS) metastatic colorectal cancer
* Cohort 3: Non-small cell lung cancer (NSCLC)
* Cohort 4: Solid tumor, tumor types and clinical setting to be determined based on emerging data.

  • Overall Status
    Recruiting
  • Start Date
    November 1, 2024
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)

Primary Outcome 1 - Timeframe: Baseline up to Cycle 2 (each cycle is 21 days)

Primary Outcome 2 - Measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)

Primary Outcome 2 - Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Primary Outcome 3 - Measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)

Primary Outcome 3 - Timeframe: Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

Primary Outcome 4 - Measure: Objective Response Rate - Percentage of Participants With Objective Response (Part 3)

Primary Outcome 4 - Timeframe: Date of first dose up to 2 years

CONDITION

  • Non Small Cell Lung Cancer
  • Bladder Cancer
  • Renal Cell Carcinoma
  • Melanoma
  • Head and Neck Cancer
  • Colorectal Cancer

ELIGIBILITY

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 <12 weeks prior to starting study treatment. - 5. Active or history of clinically significant gastrointestinal (GI) disease. - 6. Active or history of interstitial lung disease or Grade ≥2 pneumonitis. - 7. Active or history of clinically significant autoimmune disease. - 8. Active bleeding disorder. - 9. Participants who have undergone treatment with any investigational IL-12 agent. - 10. Active, uncontrolled infections

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

LOCATION

Facility Status Contact
Facility: START Midwest
Grand Rapids, Michigan 49546
United States 		Status: Recruiting Contact: N/A

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