Informations générales (source: ClinicalTrials.gov)
AN OPEN-LABEL PHASE 1 STUDY TO INVESTIGATE PF-08046031 IN ADULTS WITH ADVANCED MELANOMA AND OTHER SOLID TUMORS
Interventional
Phase 1
Pfizer (Voir sur ClinicalTrials)
mai 2025
juin 2030
30 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
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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