Status:
RECRUITING
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Carcinoma, Non-Small-Cell Lung
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect i...
Eligibility Criteria
Inclusion
- Parts A and B:
- Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
- Esophageal squamous cell carcinoma (SCC)
- Triple negative breast cancer (TNBC)
- Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
- Participants must have PD-L1 expression based on historical testing
- Part C:
- Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
- HNSCC
- Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
- NSCLC
- Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
- Esophageal SCC
- Ovarian cancer
- Melanoma
- TNBC
- Gastric cancer
- Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \<1 by CPS or TPS based on historical testing
- Part D and Part E:
- Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
- Participants must have PD-L1 expression based on historical testing
- Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
- Participants with HNSCC; PD--L1 expression ≥1 by CPS
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
Exclusion
- History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
- Known active central nervous system metastases. 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
- Have no new or enlarging brain metastases
- And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
- Lepto-meningeal disease
- Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
- Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
- Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
- There are additional inclusion criteria. The study center will determine if criteria for participations are met.
Key Trial Info
Start Date :
October 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2028
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT05208762
Start Date
October 25 2022
End Date
April 8 2028
Last Update
December 18 2025
Active Locations (62)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States, 35249
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
4
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294