Clinical Trials Directory

Trials / Terminated

TerminatedNCT06580938

A Study to Learn About 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

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPF-07921585IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously
BIOLOGICALSasanlimabAnti-PD1 antibody solution, administered once every 3 weeks subcutaneously

Timeline

Start date
2024-11-11
Primary completion
2025-07-14
Completion
2025-07-14
First posted
2024-08-30
Last updated
2026-03-23

Locations

9 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06580938. Inclusion in this directory is not an endorsement.