A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08098488 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS.

Study Identifier:
C6261001
CT.gov Identifier:
NCT07903415
EudraCT Identifier:
202652766032
EU Trial (CTIS) Number:
2026-527660-32-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08098488) in people with advanced solid tumors (cancer that cannot be removed with surgery or has spread to other parts of the body). PF-08098488 is being studied as a possible treatment for certain types of cancer. These include non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, and esophageal cancer. This study will also help researchers learn how the study medicine moves through and affects the body.

This study is seeking adults who:

  • Have advanced non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, or esophageal cancer.
  • Have received at least 1 previous treatment for their cancer.
  • Have cancer that has grown, returned, or is no longer responding to available treatments.

All participants in this study will receive PF-08098488 as an IV infusion (given directly into a vein) at the study clinic. Researchers will study different dose levels and dosing schedules to find the dose that is safe and may work best. Participants will be monitored closely during treatment, especially after their first infusion. They may continue receiving the study medicine as long as their cancer is not getting worse and they are tolerating treatment.

The study includes a screening period of up to 28 days. Participants will have regular visits to the study clinic for treatment and health assessments. These assessments include scans to monitor the cancer and blood sample collection. Tumor tissue samples will also be collected when available or medically feasible. After treatment ends, participants will have a follow-up visit about 1 month later. They will then be contacted about every 12 weeks to check on their health.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1 Dose Escalation
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Drug: Different groups of participants will receive different doses and/or schedules of the study drug
Drug: Drug: PF-08098488
Drug: IV infusion
Drug: EXPERIMENTAL: Part 2 Dose Expansion
Drug: Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Drug: EXPERIMENTAL: Part 2 Dose Optimization
Drug: Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • * 18 years of age or older
  • * Advanced non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer (including gastroesophageal junction carcinoma), or esophageal cancer.
  • * Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
  • * Measurable disease
  • * Must have received at least 1 prior approved systemic therapy:
  • * Part 1: progression or relapse following standard treatments and have no other appropriate standard of care option.
  • * Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting.
  • * 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 an auristatin or microtubule inhibitor payload.
  • * Unacceptable renal, hepatic, hematologic, cardiologic, pulmonary, or abnormalities as defined by the protocol.
  • * Pre-existing sensory or motor neuropathy.
  • * Uncontrolled diabetes mellitus.
  • * Clinically significant and/ or symptomatic eye disease meeting protocol exclusion criteria.
  • * Pulmonary (lung) disease meeting protocol exclusion criteria.

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Recruiting
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site