A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors

NCT06799533 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C59010012024-514745-10-00
• Study Type: interventional
• Target: 11
• Locations: 5 countries
• Sites: 11

Brief Summary

This study will test the safety of a drug called PF-08046031 in participants with melanoma and other solid tumors that have no current approved treatment or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. The study will have 3 parts. Part A and B of the study will find out how much PF-08046031 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046031 is safe and if it works to treat solid tumor cancers.

Conditions

Malignant Melanoma; Melanoma; Metastatic Melanoma; Solid Tumors

Keywords

Solid tumors; Other Solid tumors

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs)

  Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  through 30 days after the last study treatment; approximately 6 months

• Number of participants with laboratory abnormalities

  through 30days after the last study treatment; approximately 6 months

• Number of participants with dose limiting toxicities

  up to 28 days

Secondary Outcomes (10)

• number of participants with antidrug antibodies

  through 30 days after the last study treatment; approximately 6 months

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

  Through 30 days after the last study treatment; approximately 6 months

• PK parameter - Maximum Concentration (Cmax)

  Through 30 days after the last study treatment; approximately 6 months

• PK parameter - Time to maximum concentration (Tmax)

  Through 30 days after the last study treatment; approximately 6 months

• PK parameter - Apparent terminal half-life (t1/2)

  Through 30 days after the last study treatment; approximately 6 months

Study Arms (1)

PF-08046031 monotherapy

EXPERIMENTAL

PF-08046031

Drug: PF-08046031

Interventions

PF-08046031 DRUG

Given into the vein (IV; intravenous)

PF-08046031 monotherapy

Eligibility Criteria

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

You may qualify if:

• Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
• Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
• For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease per RECIST v1.1 at baseline
• Participants who have refused available standard of care therapies are not eligible.

You may not qualify if:

• Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease.
• Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
• Grade 3 or higher pulmonary disease unrelated to underlying malignancy. Previous history of non-infectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening.
• Other protocol specific criteria might apply.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate

Los Angeles, California, 90025, United States

Location

The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate

Los Angeles, California, 90025, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

UCSF Medical Center, Investigational Pharmacy

San Francisco, California, 94158, United States

Location

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)

Santa Monica, California, 90404, United States

Location

Presbyterian/ St. Lukes Medical Center

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute at HealthONE - SCRI - PPDS

Denver, Colorado, 80218, United States

Location

Gustave Roussy

Villejuif, Val-de-marne, 94800, France

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

Location

Karolinska Universitetssjukhuset Solna

Solna, Stockholms LÄN [se-01], 171 64, Sweden

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single group assignment

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 1, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); SE (1); US (7); ES (1); FR (1)