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

NCT06580938 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C5461001NCT06580938
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Interleukin-12 mutein; Sasanlimab; anti-PD1 antibody; lung cancer

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2)

  Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication

  Baseline up to Cycle 2 (each cycle is 21 days)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2)

  AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2)

  Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

  Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab

• Objective Response Rate - Percentage of Participants With Objective Response (Part 3)

  Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

  Date of first dose up to 2 years

Secondary Outcomes (19)

• Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3)

  Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab

• Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2)

  Date of first dose up to 2 years

• Duration of response (DOR)-Parts 1-3

  Date of first dose up to 2 years

• Disease control rate (DCR)-Parts 1-3

  Date of first dose up to 2 years

• Progression Free survival (PFS)-Parts 1-3

  Date of first dose until disease progression or death, up to a maximum of 4 years

Study Arms (3)

Part 1

EXPERIMENTAL

Dose escalation monotherapy

Biological: PF-07921585

Part 2

EXPERIMENTAL

Dose escalation (combination therapy)

Biological: PF-07921585; Biological: Sasanlimab

Part 3

EXPERIMENTAL

Dose optimization/ expansion (combination therapy)

Biological: PF-07921585; Biological: Sasanlimab

Interventions

PF-07921585 BIOLOGICAL

IL-12 mutein, solution, administered once every 3 weeks intravenously or subcutaneously

Part 1; Part 2; Part 3

Sasanlimab BIOLOGICAL

Anti-PD1 antibody solution, administered once every 3 weeks subcutaneously

Also known as: PF-06801591

Part 2; Part 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Presbyterian/St. Lukes Medical Center

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists Sarasota Drug Development Unit

Sarasota, Florida, 34232, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Sarah Cannon Research Institute- Pharmacy

Nashville, Tennessee, 37203, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Urinary Bladder Neoplasms; Carcinoma, Renal Cell; Melanoma; Head and Neck Neoplasms; Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 30, 2024
• Study Start: November 11, 2024
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)