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

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

NCT ID: NCT06580938

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

Conditions: Official terms:
Carcinoma, Renal Cell

Conditions: Keywords:
Interleukin-12 mutein
Sasanlimab
anti-PD1 antibody
lung cancer

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: PF-07921585
Description: IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously
Arm group label: Part 1
Arm group label: Part 2
Arm group label: Part 3

Intervention type: Biological
Intervention name: Sasanlimab
Description: Anti-PD1 antibody solution, administered once every 3 weeks subcutaneously
Arm group label: Part 2
Arm group label: Part 3

Other name: PF-06801591

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.

Criteria for 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 <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

Locations:

Facility:
Name: Highlands Oncology Group

Address:
City: Fayetteville
Zip: 72703
Country: United States

Status: Not yet recruiting

Facility:
Name: Highlands Oncology Group

Address:
City: Rogers
Zip: 72758
Country: United States

Status: Not yet recruiting

Facility:
Name: Highlands Oncology Group

Address:
City: Springdale
Zip: 72762
Country: United States

Status: Not yet recruiting

Facility:
Name: START Midwest

Address:
City: Grand Rapids
Zip: 49546
Country: United States

Status: Recruiting

Start date: November 1, 2024

Completion date: November 15, 2028

Lead sponsor:
Agency: Pfizer
Agency class: Industry

Source: Pfizer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06580938
https://pmiform.com/clinical-trial-info-request?StudyID=C5461001