Molecularly Matched Therapy for Cancer

(STRIPe Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: High tumor mutational burden, Microsatellite instability-high, Mismatch repair deficiency, Symptomatic brain metastases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if drugs that are matched to tumor DNA mutations work to treat metastatic solid cancers in adults. The main questions it aims to answer are:

Is tumor worsening delayed for a longer period of time if patients take drugs that match DNA mutations, compared to if they take standard of care drugs?

Researchers will compare drugs matched to tumor DNA mutations to standard of care drugs to see if the matched drugs work better, and to see if tumor worsening can be delayed for longer the more DNA mutations the drugs target.

Participants will:

Take drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule of the drugs.

Visit the clinic every approximately 2 months for checkups and tumor imaging.

Who Is on the Research Team?

Jason K. Sicklick, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

Adults with metastatic or unresectable solid cancers, who have had up to two prior cancer treatments and a life expectancy of 6-16 months. They must have tumors with specific DNA mutations that can be targeted by drugs recommended by a Molecular Tumor Board, based on recent tumor imaging and molecular profiling.

Inclusion Criteria

I have signed the consent form for this trial.

My cancer treatment plan was approved by a Molecular Tumor Board.

My latest cancer imaging was done less than 4 weeks ago or can be done soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive drugs matched to tumor DNA mutations or standard of care drugs based on the regular dosing schedule

12 months

Clinic visits approximately every 2 months for checkups and tumor imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Molecularly matched therapy

Trial Overview

The trial is testing if using drugs tailored to match patients' tumor DNA mutations is more effective in delaying cancer progression than standard cancer care. Patients will receive either the matched therapy or standard treatment and undergo regular checkups and tumor imaging every two months.

How Is the Trial Designed?

Group I: Molecularly matched therapy Experimental Treatment 1 Intervention

Molecularly matched therapy based on tumor's molecular profile.

Group II: Standard of care Active Control 1 Intervention

Standard of care treatment.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+