Sarcoma & Solid Tumor Clinical Trial (Pediatric)- Currently Recruiting

Updated: May 5

First Ascent in partnership with FIU and Nicklaus Children's Hospital in Miami, FL are conducting a trial across multiple sarcoma types. Target patients are aged 21 and younger with newly diagnosed or recurrent cancer. Enrolling now through December 2022 until enrollment quota reached.

Specific Sarcomas are identified in the study homepage link below.

This study is a prospective, non-randomized observational study. Freshly isolated tumor cells will be tested for chemosensitivity to the standard of care drugs as single agents and in combinations using state-of-the-art viability assay designed for ex-vivo high-throughput drug sensitivity testing (DST). In addition, the genetic profile of the tumor will be obtained from the medical records and correlated with drug response using AI/ML to determine ideal treatments for individual patients.

Further Trial Details:

The excised tumors, or a biopsy, will be interrogated for sensitivity or resistance to FDA-approved and/or available investigational agents. In addition, normal samples (blood or buccal swab) will be collected for genetic analysis of germline mutations and cancer predisposition markers. The timeframe between the sample acquisition and ex vivo DST results return will be approximately 5-10 working days. All drugs tested in the DST assay will be assigned a hybrid score reflecting the tumor's sensitivity and drug toxicity.

This is an observational study and not a treatment protocol. It will assess how ex vivo drug testing and mutation profiling may predict clinical outcomes (response, survival, or relapse). The treating physician will decide which of the standard treatment options is appropriate independent of the DST results. The results of DST will not be available to the treating physician at the time of decision on the treatment regimen. DST will include all drugs from the standard treatment regimens available for all types of sarcomas

To find more information, please visit the study homepage at:

Drug Sensitivity and Mutation Profiling

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First Ascent Biomedical in partnership with FIU and Nicklaus Children's Hospital executing 22 patient trial. Dr. Diana Azzam, First Ascent's CSO, is leading a clinical trial for 22 pediatric patients