Early trial of PF-08046031 for advanced cancers ends early
NCT ID NCT06799533
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested a new drug called PF-08046031 in 11 adults with advanced melanoma or other solid tumors that had spread or had no standard treatment options. The main goal was to check the drug's safety and side effects. The trial was terminated early, so its findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08046031 (a drug given into the vein)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced melanoma and other solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 11 participants, and it was terminated early, so results are limited. The drug may not prove effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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11 people
The number who actually took part.
- Started
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May 2025
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 • Participants who have refused available standard of care therapies are not eligible. 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 • 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gustave Roussy
Villejuif, Val-de-marne, 94800, France
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
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Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01], 171 64, Sweden
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Presbyterian/ St. Lukes Medical Center
Denver, Colorado, 80218, United States
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Sarah Cannon Research Institute at HealthONE - SCRI - PPDS
Denver, Colorado, 80218, United States
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The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
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The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate
Los Angeles, California, 90025, United States
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The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404, United States
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The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
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UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158, United States
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