Carcinoma, Non-Small-Cell Lung study: PF-08046054 vs Pembrolizumab
Official title A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05208762
What this study is testing
What is PF-08046054?
an investigational IV medicine being studied as a potential treatment for metastatic or unresectable non‑small‑cell lung carcinoma and other solid tumors is designed to block the PD‑L1 protein, helping the immune system recognize and attack cancer cells
Also referred to as SGN-PDL1V.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe the drug is, what side effects it may cause, and whether it shows any activity against solid tumors.
- Who it's for
- Adults whose solid tumor cancer has spread or cannot be removed by surgery, including lung, head‑and‑neck, esophageal, breast, gastric, endometrial, pancreatic, or liver cancers.
- What's involved
- Participants will receive PF-08046054/SGN‑PDL1V alone or together with pembrolizumab, with dose‑finding in early parts and safety checks in later parts, plus regular medical exams and lab tests.
- Time commitment
- The trial runs for several months and requires multiple clinic visits for drug infusions and safety assessments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed...
- 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.
See the full eligibility criteria
- 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...
- Participants must have PD-L1 expression based on historical testing
- 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
- Pancreatic cancer
- Hepatocellular carcinoma
- TNBC
- Gastric cancer
- Endometrial 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
- 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
- History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
- 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 team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Irvine, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Iowa City, Iowa, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Richardson, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Anderlecht, Belgium
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Irvine, California, United States; Orange, California, United States; Sacramento, California, United States; Iowa City, Iowa, United States; Detroit, Michigan, United States and 34 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.