A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

NCT06974734 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C59410012025-521499-69-00
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 15

Brief Summary

The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies. This study is seeking participants who:

• have advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, or pancreatic ductal adenocarcinoma (PDAC);
• are able to provide tumor tissue samples;
• have measurable disease. All participants will receive while at the clinic PF-08046037 alone as an intravenous (IV) infusion (given directly into a vein) or with sasanlimab as a subcutaneous (SQ) injection (given under the skin) once every 3 weeks. Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Conditions

Malignant Melanoma; Carcinoma, Non Small Cell Lung; Carcinoma, Pancreatic Ductal; Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Keywords

Advanced solid tumors; NSCLC; PDAC; HNSCC; ISAC; ADC; PD-L1 inhibitor

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

  Through 30-37 days after the last study treatment, up to approximately 2 years

• Number of participants with laboratory abnormalities

  Through 30-37 days after the last study treatment, up to approximately 2 years

• Number of dose modifications due to AEs

  Through end of treatment up to approximately 2 years

• Number of participants with dose-limiting toxicities (DLTs)

  Up to 21 days

• Number of participants with DLTs by dose level

  Up to 21 days

Secondary Outcomes (12)

• Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)

  Through 30-37 days after the last study treatment, up to approximately 2 years

• PK parameter - Maximum concentration (Cmax)

  Through 30-37 days after the last study treatment, up to approximately 2 years

• PK parameter - Time to maximum concentration (Tmax)

  Through 30-37 days after the last study treatment, up to approximately 2 years

• PK parameter - t1/2

  Through 30-37 days after the last study treatment, up to approximately 2 years

• PK parameter - Trough concentration (Ctrough)

  Through 30-37 days after the last study treatment, up to approximately 2 years

Study Arms (6)

Part 1a

EXPERIMENTAL

PF-08046037 monotherapy dose escalation

Drug: PF-08046037

Part 2a

EXPERIMENTAL

PF-08046037 monotherapy dose optimization

Drug: PF-08046037

Part 3a

EXPERIMENTAL

PF-08046037 monotherapy dose expansion

Drug: PF-08046037

Part 1b

EXPERIMENTAL

PF-08046037 +sasanlimab dose escalation

Drug: PF-08046037; Drug: sasanlimab

Part 2b

EXPERIMENTAL

PF-08046037 + sasanlimab dose optimization

Drug: PF-08046037; Drug: sasanlimab

Part 3b

EXPERIMENTAL

PF-08046037 + sasanlimab dose expansion

Drug: PF-08046037; Drug: sasanlimab

Interventions

PF-08046037 DRUG

Given into the vein (IV; intravenous)

Also known as: SGN-PDL1iT

Part 1a; Part 1b; Part 2a; Part 2b; Part 3a; Part 3b

sasanlimab DRUG

Given under the skin (SQ; subcutaneous)

Also known as: PF-06801591

Part 1b; Part 2b; Part 3b

Eligibility Criteria

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

This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below. 1. Tumor types * Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts * Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC * Must have progressive disease following at least 1 prior approved systemic therapy * Monotherapy Dose Expansion (Part 3a) • Advanced or metastatic NSCLC or PDAC * Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b) * Advanced or metastatic NSCLC or HNSCC * May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy * Combination Dose Expansion (Part 3b) * Unresectable locally advanced or metastatic HNSCC or NSCLC * Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting) * Must be treatment naïve to any immunotherapy * NSCLC must have PD-L1 expression TPS \>=50% * HNSCC must have PD-L1 expression CPS \>=1 2. Tissue requirement * Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory * Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment * Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required * Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment * Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor 3. Measurable disease per RECIST v1.1 Participants who meet the following might not be able to participate. 1. History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy 2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent 3. History of uveitis within the preceding 6 months 4. Clinically significant Grade \>=3 neurodegenerative disease 5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy 6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Presbyterian/ St. Lukes Medical Center

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Smilow Cancer Hospital - Yale New Haven Health

New Haven, Connecticut, 06510, United States

Location

Yale - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, 06511, United States

Location

Smilow Cancer Hospital - Trumbull

Trumbull, Connecticut, 06611, United States

Location

Community Health Network, Inc

Indianapolis, Indiana, 46219, United States

Location

Community Health Network, Inc.

Indianapolis, Indiana, 46227, United States

Location

Community Health Network, Inc.

Indianapolis, Indiana, 46250, United States

Location

Community Health Network, Inc.

Indianapolis, Indiana, 46256, 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

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

Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Melanoma; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System 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; Carcinoma, Squamous Cell; Head and Neck Neoplasms

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

Model Details: Dose escalation and expansion

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 16, 2025
• Study Start: May 6, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); PR (1)