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RecruitingPhase 1

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With 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

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study drug will be given to participants through a needle in a vein (intravenous infusion)."
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 and effects of PF-08046876 in adults with advanced cancer of the bladder, lung, head and neck, esophagus (food pipe), or pancreas. This study drug is designed to stick to cancer cells and kill them, and it is given through a needle in a vein. The study tests different doses and schedules, and later tests it with other cancer drugs.

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.

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

Eligibility

Who can join

  • Age 18 or older, with one of the advanced cancers listed above.
  • Have cancer that can be measured.
  • Can do all usual activities or most activities except heavy physical work.
  • Part 1: Cancer grew or came back after standard treatments.
  • Part 2: Have had no more than 2 courses of treatment that acts throughout the body for advanced cancer.
  • Part 3: Have advanced lung or bladder cancer. Past treatment rules depend on the drug group.
  • Short-term side effects from past cancer treatment are mild or back to their level before treatment.
  • Agree to provide a tumor sample before treatment, if medically possible.

Who can't join

  • Past treatment with an antibody-drug conjugate carrying a camptothecin-type drug. This is an antibody linked to a cancer-killing drug. Examples include sacituzumab govitecan and trastuzumab deruxtecan.
  • Current loss of appetite, nausea, vomiting, or signs of a blocked intestine that meet the study's exclusion rules.
  • Lung disease that meets the study's exclusion rules.
  • Other health or test findings that are not allowed under the study rules.
  • Part 3: A medical reason you cannot take one of the other cancer drugs, based on study rules or local drug labels.

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

Official eligibility criteria

Inclusion Criteria: * 18 years of age or older * Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas * Measurable disease * ECOG Performance status 0-1 * Part 1: progression or relapse following standard treatments * Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting * Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group * Resolution of acute effects of prior anticancer therapy to baseline or Grade 1 * Consent to submit required pre-treatment tumor tissue as medically feasible Exclusion criteria: * Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan ) * Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion * Pulmonary disease meeting protocol exclusion * Other unacceptable abnormalities as defined by protocol * Part 3: Meet contraindications of combination products per protocol and/or local labels

Study sites (21)

CA

CT

MA

TN

TX