Clinical trial NCT06799533: A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors
Official title: AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Malignant Melanoma
Melanoma
Metastatic Melanoma
Solid Tumors
Keywords: Solid tumors
Other Solid tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: single group assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
  * 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

Exclusion Criteria:

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

Other protocol specific criteria might apply.

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Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: through 30 days after the last study treatment; approximately 6 months
measure: Number of participants with laboratory abnormalities
timeFrame: through 30days after the last study treatment; approximately 6 months
measure: Number of participants with dose limiting toxicities
timeFrame: up to 28 days
Secondary outcomes:
measure: number of participants with antidrug antibodies
timeFrame: through 30 days after the last study treatment; approximately 6 months
measure: Pharmacokinetic (PK) parameter - Area under the curve (AUC)
timeFrame: Through 30 days after the last study treatment; approximately 6 months
measure: PK parameter - Maximum Concentration (Cmax)
timeFrame: Through 30 days after the last study treatment; approximately 6 months
measure: PK parameter - Time to maximum concentration (Tmax)
timeFrame: Through 30 days after the last study treatment; approximately 6 months
measure: PK parameter - Apparent terminal half-life (t1/2)
timeFrame: Through 30 days after the last study treatment; approximately 6 months
measure: PK parameter - Trough concentration (Ctrough)
timeFrame: Through 30 days after the last study treatment; approximately 6 months
measure: Objective response rate (ORR)
timeFrame: Up to approximately 1 year
measure: Duration of response (DOR)
timeFrame: Up to approximately 1 year
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 1 year
measure: Overall survival (OS)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
state: California
city: Santa Monica
country: United States
facility: The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE - SCRI - PPDS
state: Colorado
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Sarah Cannon Research Institute at Florida Cancer Specialists
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: