A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Jan 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called PF-08046054/SGN-PDL1V to see how safe it is for patients with advanced solid tumors, which are cancers that have spread in the body or cannot be surgically removed. The trial will also look at how this drug works on its own and when combined with another medication called pembrolizumab. The study is divided into five parts, where researchers will determine the right dose of the drug and monitor its effects on various types of cancer, including lung cancer, head and neck cancer, esophageal cancer, ovarian cancer, melanoma, triple-negative breast cancer, and gastric cancer.

To be eligible for this trial, participants should have a specific type of solid tumor that has either not responded to previous treatments, has come back after treatment, or could not be treated with standard therapies. Key criteria include having confirmed cancer types and a certain level of a protein called PD-L1, which may help predict how well the treatment will work. Participants can expect close monitoring throughout the study to assess their health and any side effects from the treatment. If you or a loved one are considering participation, the study team can provide more details about eligibility and what to expect during the trial.

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Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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.