Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08634404: -Concentrate for solution for infusion

Sigvotatug Vedotin: -Powder for concentrate for solution for infusion. Single use vial

PF-08046054/SGN-PDL1V: -Powder for concentrate for solution for infusion. Single use vial.

Study summary

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.

To join in the study, participants must:

* Be 18 years or older
* Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body

The study will look at:

* Whether PF-08634404 is safe to use with other cancer medicines.
* What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease.
* Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors.

The study has different parts, each testing PF-08634404 with a different cancer medicine:

* Part A will test PF-08634404 with a medicine called sigvotatug vedotin.
* Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V

Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

Eligibility

Primary outcome measure(s)

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through 90 days after the last study intervention; Up to approximately 5 years
  AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
• Phase I: Number of participants with dose limiting toxicity (DLT) — Through 90 days after the last study intervention; Up to approximately 5 years
  Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
• Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator — Up to approximately 5 Years
  ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.

Trial sites (104)

+ 64 more sites — see the full list on the official registry below.

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