Clinical trial · Interventional
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
A Phase 1 Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was terminated for strategic reasons. The decision was not based on any safety concerns.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-08046049 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PF-08046049
- description
- PF-08046049 monotherapy
- interventionNames
- Drug: PF-08046049
Primary outcomes (3)
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Through 30 days after the last study treatment; approximately 7 months
- description
- 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.
- measure
- Number of participants with laboratory abnormalities
- timeFrame
- Through 30 days after the last study treatment; approximately 7 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 excludedReferences
Publications (0)
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