RecruitingPhase 1NCT05932862

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors


Sponsor

Exelixis

Enrollment

429 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called XL309 (also known as ISM3091), alone or in combination with other treatments, in people with advanced solid tumors. The study is looking at safety and the right dose. **You may be eligible if...** - You are 18 or older and in good general health (ECOG 0–1) - You have advanced cancer that has stopped responding to standard treatments or for which no standard treatment exists - Your cancer is one of the eligible types, such as: HER2-negative breast cancer with BRCA1/2 mutation, ovarian or pancreatic cancer, prostate cancer, certain lung cancers, or other specific tumor types - Your bone marrow and organs are functioning adequately **You may NOT be eligible if...** - You are not in good enough general health to participate - Your organs (liver, kidneys, blood counts) are not functioning at required levels - You have had recent cancer treatments without adequate recovery time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGXL309

XL309 will be administered orally per assigned schedule.

DRUGOlaparib

Olaparib will be administered orally per assigned schedule.


Locations(16)

Exelixis Clinical Site #12

Fountain Valley, California, United States

Exelixis Clinical Site #15

Jacksonville, Florida, United States

Exelixis Clinical Site #8

Orlando, Florida, United States

Exelixis Clinical Site #16

Tampa, Florida, United States

Exelixis Clinical Site #14

Rochester, Minnesota, United States

Exelixis Clinical Site #10

Kansas City, Missouri, United States

Exelixis Clinical Site #9

New Brunswick, New Jersey, United States

Exelixis Clinical Site #5

New York, New York, United States

Exelixis Clinical Site #7

Cleveland, Ohio, United States

Exelixis Clinical Site #13

Oklahoma City, Oklahoma, United States

Exelixis Clinical Site #11

Germantown, Tennessee, United States

Exelixis Clinical Site #6

Nashville, Tennessee, United States

Exelixis Clinical Site #4

Austin, Texas, United States

Exelixis Clinical Site #1

Houston, Texas, United States

Exelixis Clinical Site #2

Houston, Texas, United States

Exelixis Clinical Site #3

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05932862


Related Trials