Colorectal Neoplasms, Cutaneous Melanoma, Mesothelioma, Non-small Cell Lung Cancer, Pancreatic Neoplasms
Conditions
Keywords
NSCLC, Colorectal Cancer, CRC, Pancreatic Cancer
Brief summary
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat 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. This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers.
Interventions
DRUGPF-08046049
Given into the vein (IV; intravenous)
Sponsors
Seagen, a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy. * Participants must have one of the following tumor types: * Parts A and B: Participants must have metastatic or unresectable cutaneous melanoma. * Part C: Participants must have one of the following tumor types: * Cutaneous Melanoma * Non-small Cell Lung Cancer (NSCLC) * Colorectal Cancer (CRC) * Pancreatic Cancer * Mesothelioma * A pre-treatment biopsy or submission of archival tissue is required * For participants with cutaneous melanoma * Must have been previously treated with an anti-programmed death-1 (anti-PD-1) or anti-programmed death ligand-1 (anti-PD-L1) agent given alone or with other therapies. * Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with BRAF/MEK targeted therapy prior to study entry. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease per RECIST v1.1 at baseline
Exclusion criteria
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * Active central nervous system metastases or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are: * clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, * they have no new or enlarging brain metastases, * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. * Prior therapies cannot include any drugs targeting CD228 or 4-1BB * Immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment * Melanoma subtypes including acral, uveal, and mucosal are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with laboratory abnormalities | Through 30 days after the last study treatment; approximately 7 months | — |
| Number of participants with dose limiting toxicities | Up to 28 days | — |
| Number of participants with adverse events (AEs) | Through 30 days after the last study treatment; approximately 7 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| PK parameter - Apparent terminal half-life (t1/2) | Through 30 days after the last study treatment; approximately 7 months | To be summarized using descriptive statistics |
| Number of participants with antidrug antibodies | Through 30 days after the last study treatment; approximately 7 months | To be summarized using descriptive statistics |
| Pharmacokinetic (PK) parameter - Area under the curve (AUC) | Through 30 days after the last study treatment; approximately 7 months | To be summarized using descriptive statistics |
| PK parameter - Maximum Concentration (Cmax) | Through 30 days after the last study treatment; approximately 7 months | To be summarized using descriptive statistics |
| PK parameter - Trough concentration (Ctrough) | Through 30 days after the last study treatment; approximately 7 months | To be summarized using descriptive statistics |
| PK parameter - Time to maximum concentration (Tmax) | Through 30 days after the last study treatment; approximately 7 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 investigator |
| 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 |
Countries
Canada, France, Germany, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed