A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors

NCT06285097 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C5391001NCT06285097
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 10

Brief Summary

This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.

Conditions

Neoplasms; Non-small-cell Lung Cancer; Melanoma; Squamous Cell Carcinoma of the Head and Neck; Renal Cell Carcinoma; Urothelial Carcinoma; Colorectal Carcinoma; Ovarian Carcinoma

Keywords

Sasanlimab; anti-Programmed death receptor-1 (PD-1); solid tumor; immunotherapy

Outcome Measures

Primary Outcomes (4)

• Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B)

  DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period

  Baseline through 28 days after first dose

• Number of patients with adverse events (AEs)

  Characterized by type, frequency, severity (CTCAE v5; CRS by ASTCT), timing, seriousness, and relationship to study drug(s)

  Baseline through up to 2 years

• Number of patients with clinically significant lab abnormalities

  Characterized by type, frequency, severity (CTCAE v5), and timing

  Baseline through up to 2 years

• Objective response rate (ORR) in Part 2 Expansion

  Tumor response as assessed using RECIST 1.1

  Baseline through 2 years or disease progression

Secondary Outcomes (13)

• Objective response rate (ORR) in dose escalation (Part 1A and Part 1B)

  Baseline through 2 years or disease progression

• Duration of tumor response

  Baseline through 2 years or disease progression

• Progression free survival (PFS)

  Baseline through 2 years or disease progression

• Cmax (maximum concentration) of PF-07820435 and its active metabolite

  Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.

• Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite

  Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.

Study Arms (5)

Monotherapy dose escalation (Part 1A)

EXPERIMENTAL

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Drug: PF-07820435

Combination dose escalation (Part 1B)

EXPERIMENTAL

Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles

Drug: PF-07820435; Biological: Sasanlimab

Expansion (Part 2) - Tumor specific Arm A

EXPERIMENTAL

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Drug: PF-07820435; Biological: Sasanlimab

Expansion (Part 2) - Tumor specific Arm B

EXPERIMENTAL

Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles

Drug: PF-07820435; Biological: Sasanlimab

Expansion (Part 2) - Arm C

EXPERIMENTAL

Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles

Drug: PF-07820435

Interventions

PF-07820435 DRUG

immune agonist

Combination dose escalation (Part 1B); Expansion (Part 2) - Arm C; Expansion (Part 2) - Tumor specific Arm A; Expansion (Part 2) - Tumor specific Arm B; Monotherapy dose escalation (Part 1A)

Sasanlimab BIOLOGICAL

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2

Combination dose escalation (Part 1B); Expansion (Part 2) - Tumor specific Arm A; Expansion (Part 2) - Tumor specific Arm B

Eligibility Criteria

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

You may qualify if:

• Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
• Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
• Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
• Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
• At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
• Able to provide pre-treatment (and optional on-treatment) tumor tissue

You may not qualify if:

• Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
• Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
• Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
• History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Florida Cancer Specialists Sarasota Drug Development Unit

Sarasota, Florida, 34232, United States

Location

Corewell Health (reference non-engagement letter)

Grand Rapids, Michigan, 49503, 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

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

Location

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

Rio Piedras, 00935, Puerto Rico

Location

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935, Puerto Rico

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Colorectal Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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: January 23, 2024
• First Posted: February 29, 2024
• Study Start: February 8, 2024
• Primary Completion: January 3, 2025
• Study Completion: February 13, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); PR (2); US (6)