Malignant Melanoma, Melanoma, Metastatic Melanoma, Solid Tumors
Conditions
Keywords
Solid tumors, Other Solid tumors
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.
Interventions
DRUGPF-08046031
Given into the vein (IV; intravenous)
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Intervention model description
single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | through 30 days after the last study treatment; approximately 6 months | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| number of participants with antidrug antibodies | through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| Pharmacokinetic (PK) parameter - Area under the curve (AUC) | Through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| PK parameter - Maximum Concentration (Cmax) | Through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| PK parameter - Time to maximum concentration (Tmax) | Through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| PK parameter - Apparent terminal half-life (t1/2) | Through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| PK parameter - Trough concentration (Ctrough) | Through 30 days after the last study treatment; approximately 6 months | To be summarized using descriptive statistics |
| Objective response rate (ORR) | Up to approximately 1 year | The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigato |
| Duration of response (DOR) | Up to approximately 1 year | The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause |
| Progression-free survival (PFS) | Up to approximately 1 year | The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause |
| Overall survival (OS) | Approximately 2 years | The time from the start of study treatment to death due to any cause |
Countries
France, Spain, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed