Status:
TERMINATED
A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer
Lead Sponsor:
Pfizer
Conditions:
Non Small Cell Lung Cancer
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 combinat...
Eligibility Criteria
Inclusion
- Key
- 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.
- 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.
- ECOG PS 0 or 1.
- Key
Exclusion
- 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.
- Active or history of clinically significant autoimmune disease.
- Active bleeding disorder.
- Participants who have undergone treatment with any investigational IL-12 agent.
- Active, uncontrolled infections
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06580938
Start Date
November 11 2024
End Date
July 14 2025
Last Update
August 19 2025
Active Locations (8)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
4
Presbyterian/St. Lukes Medical Center
Denver, Colorado, United States, 80218