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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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.

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06799533
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma, Melanoma, Metastatic Melanoma, Solid Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: PF-08046031 monotherapy

PF-08046031

Interventions

Drug: - PF-08046031

Given into the vein (IV; intravenous)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles 5368361, California 5332921

Status

Recruiting

Address

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

Los Angeles 5368361, California 5332921, 90025

Site Contact

[email protected]

1-800-718-1021

San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco 5391959, California 5332921, 94143

Site Contact

[email protected]

1-800-718-1021

San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF Medical Center, Investigational Pharmacy

San Francisco 5391959, California 5332921, 94158

Site Contact

[email protected]

1-800-718-1021

Santa Monica 5393212, California 5332921

Status

Recruiting

Address

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

Santa Monica 5393212, California 5332921, 90404

Site Contact

[email protected]

1-800-718-1021

Denver 5419384, Colorado 5417618

Status

Recruiting

Address

Sarah Cannon Research Institute at HealthONE - SCRI - PPDS

Denver 5419384, Colorado 5417618, 80218

Site Contact

[email protected]

1-800-718-1021

Florida Cancer Specialists, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Florida Cancer Specialists

Orlando 4167147, Florida 4155751, 32827

Site Contact

[email protected]

1-800-718-1021

Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando 4167147, Florida 4155751, 32827

Site Contact

[email protected]

1-800-718-1021

UPMC Hillman Cancer Center, Pittsburgh 5206379, Pennsylvania 6254927

Status

Not yet recruiting

Address

UPMC Hillman Cancer Center

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Site Contact

[email protected]

1-800-718-1021

UPMC Shadyside Hospital, Pittsburgh 5206379, Pennsylvania 6254927

Status

Not yet recruiting

Address

UPMC Shadyside Hospital

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Site Contact

[email protected]

1-800-718-1021

International Sites

Hospital Universitari Vall d'Hebron, Barcelona 3128760, Barcelona [barcelona], Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona 3128760, Barcelona [barcelona], 08035

Site Contact

[email protected]

1-800-718-1021

Karolinska Universitetssjukhuset Solna, Solna 2675397, Stockholms LÄN [se-01], Sweden

Status

Recruiting

Address

Karolinska Universitetssjukhuset Solna

Solna 2675397, Stockholms LÄN [se-01], 171 64

Site Contact

[email protected]

1-800-718-1021

Sarah Cannon Research Institute UK, London 2643743, London, CITY of, United Kingdom

Status

Not yet recruiting

Address

Sarah Cannon Research Institute UK

London 2643743, London, CITY of, w1g 6ad

Site Contact

[email protected]

1-800-718-1021

The Royal Marsden NHS Foundation Trust, Sutton 2636503, United Kingdom

Status

Recruiting

Address

The Royal Marsden NHS Foundation Trust

Sutton 2636503, , SM2 5PT

Site Contact

[email protected]

1-800-718-1021

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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