NCT07346209

Real-world Trial of Individualized Precision Oncology

STudy of Real-world Individualized Precision-oncology

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Next generation sequencing and multi-omic technologies have revealed that advanced or metastatic solid cancers often have complex molecular profiles with multiple driver alterations/biomarkers that are different from patient to patient. This molecular complexity and heterogeneity require customized treatment regimens targeting multiple driving molecular alterations/biomarkers while ensuring patient safety. The investigators conducted previously a preliminary trial on optimized personalized-precision oncology. Personalized-precision oncology entails matching patients to the best drug(s) for their tumor - including drug combinations never studied before - at the right doses to the right patients. That study demonstrated that therapy matched to each cancer's complex and unique molecular profile, as suggested by an expert molecular tumor board, is feasible and safe. In addition, the investigators showed that receipt of therapy targeting a higher proportion of molecular alterations/biomarkers in the tumor was strongly associated with longer progression free survival. The present randomized study aims to expand the previous findings to evaluate efficacy and safety of molecularly matched therapy in metastatic unresectable cancers and to develop innovative machine learning models to better predict optimal treatment for validation in future trials.

Conditions

• Metastatic Cancer
• Unresectable Carcinoma

Interventions

Type	Name	Description
DRUG	Molecularly matched therapy	Molecularly matched therapy, as identified by a molecular tumor board, to match molecular alterations/biomarkers found in the tumor or circulating tumor DNA.
DRUG	Standard of care	Standard of care therapy for the tumor type.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-03-01
• Completion: 2031-09-01
• First posted: 2026-01-16
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study