STudy of Real-world Individualized Precision-oncology
University of California, San Diego
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.
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 th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Aged at least 18 years. 4. Metastatic or unresectable solid cancers (all) with a 2-year cancer-associated mortality of ≥ 50%, or immediate prior progression free survival \< 4 months, or life expectancy between 6 and 16 months as determined at prescreening and/or enrollment due to cancer diagnosis. 5. Previous treatment with up to 2 lines of cancer therapy before enrollment. 6. Available results of tumor imagin…
Interventions
- DrugMolecularly 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.
- DrugStandard of care
Standard of care therapy for the tumor type.
Location
- University of California, San DiegoLa Jolla, California