COAST Therapy for Advanced Solid Tumors and Prostate Cancer

This study is testing different combinations of up to five oral medications – hydroxychloroquine, metformin, sirolimus, dasatinib, and nelfinavir – for people with advanced solid tumors or recurrent prostate cancer. The main goals are to find the safest dose of these drug combinations and to see how many patients experience disease control. This study is for adults aged 18 and older. For prostate cancer, you must have a PSA (prostate-specific antigen) of at least 0.1 ng/mL. The study is currently recruiting about 76 participants.

Study design
This is a Phase I/II study with an initial group of 18-30 patients to find the safest drug combinations, followed by a larger group to assess effectiveness. It uses a traditional 3+3 escalation design to test increasing components of the drug regimen.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Disease control will be measured at a minimum of 16 weeks after starting treatment. The maximum tolerated dose will be measured at a minimum of 3 months after starting treatment on each dose level.

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NCT05036226

COAST Therapy in Advanced Solid Tumors and Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Medical University of South Carolina
~76 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Hydroxychloroquine, Metformin, SirolimusHydroxychloroquine, Metformin, Sirolimus, DasatanibHydroxychloroquine, Metformin, Sirolimus, NelfinavirHydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) - Phase I
Measured over Minimum of 3 months after start of treatment on each dose level
+1 more outcome measured
Prostate Cancer Recurrent
Solid Tumor, Adult
1 sites across 1 states
South Carolina1

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  • Maximum Tolerated Dose (MTD) - Phase IMinimum of 3 months after start of treatment on each dose level

    Maximum dose achievable without dose limiting toxicities (DLT's)

  • Measure of proportion of patients with disease control - Phase IIMinimum of 16 weeks after start of treatment, per patient

    Stable disease by RECIST or PCWG3 criteria after 16 weeks of treatment on study.