OncoMatch/Clinical Trials/NCT06308419
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
Is NCT06308419 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Gemcitabine and Nab-Sirolimus for leiomyosarcoma.
Treatment: Gemcitabine · Nab-Sirolimus — To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: TSC1 deletion
Required: TSC1 loss-of-function mutation
Required: TSC2 deletion
Required: TSC2 loss-of-function mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — leiomyosarcoma only
One prior standard systemic therapy is required for leiomyosarcoma (LMS) Patients.
Cannot have received: mTOR inhibitor
Prior treatment of sarcoma with mTOR inhibitors.
Lab requirements
Blood counts
absolute neutrophil count 1,500/mcL; platelets 100,000/mcL; hemoglobin 9 gm/dL
Kidney function
eGFR (CKD-EPI) 60 mL/min
Liver function
total bilirubin 2 x institutional ULN (except Gilbert's syndrome: < 3.0 mg/dL); AST(SGOT)/ALT(SGPT) 2 d7 institutional ULN
Cardiac function
NYHA Functional Class 2B or better
Patients must have adequate organ and marrow function as defined below: i. absolute neutrophil count 1,500/mcL ii. platelets 100,000/mcL iii. hemoglobin 9 gm/dL iv. total bilirubin 2 x institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL) v. AST(SGOT)/ALT(SGPT) 2 d7 institutional ULN vi. eGFR (calculated by CKD-EPI) 60 mL/min vii. Serum triglyceride <300 mg/dL viii. Serum cholesterol <350 mg/dL ... cardiac disease ... NYHA Functional Class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify