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RecruitingPhase 1

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

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, and best dose of PF-08046054/SGN-PDL1V, alone or with pembrolizumab. It also checks whether the treatment works against solid tumors. It is for people whose cancer has spread or cannot be removed by surgery.

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 is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Parts A and B: Have non-small cell lung cancer, squamous cell cancer of the head and neck or food pipe, or triple-negative breast cancer. Cancer behind the nose is not included.
  • Parts A and B: Cancer has returned, resisted treatment, or worsened on approved treatments; or you cannot take or have refused them. The study doctor must find no suitable standard treatment.
  • Part C: Have an allowed cancer of the head and neck, lung, food pipe, pancreas, liver, breast, stomach, or lining of the womb. Only certain cancer types qualify.
  • Part C: Cancer has returned or resisted treatment, or you cannot tolerate standard treatment. Lung cancers with neuroendocrine cells do not qualify.
  • Parts D and E: Have squamous cell head and neck cancer or non-small cell lung cancer, confirmed by tissue or cell testing.
  • Have past testing for PD-L1, a protein measured in cancer testing. Parts A, B, D, and E require PD-L1 to be present. Parts D and E require a lung cancer TPS score of at least 1% or a head and neck cancer CPS score of at least 1. Part C allows scores below 1 or at least 1.
  • Be fully active or able to walk and do light work, and have cancer that can be measured on scans.
  • Other rules apply. The study center will check whether you qualify.

Who can't join

  • Another cancer within 3 years before the first study dose, or any cancer left from an earlier cancer diagnosis.
  • Active cancer spread to the brain or spinal cord. Treated brain spread may qualify if stable for at least 4 weeks, with no new or growing spots, and no steroids for related symptoms for at least 7 days before treatment.
  • Cancer in the tissue layers around the brain and spinal cord.
  • Recent treatment with an anti-PD-L1 drug. The required waiting time depends on how long that drug stays in the body.
  • Past treatment with a drug containing monomethylauristatin E (MMAE).
  • Existing nerve damage rated grade 2 or higher, which can cause numbness, tingling, or pain.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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 * 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.

Study sites (25)

AL

CA

IA

MI

OH

TX

UT

VA