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 (Jun 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
Treatments studied
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06308419 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mTOR inhibitor disqualifies patients from enrollment.
Does this trial require TSC1?
Yes, TSC1 deletion is a required biomarker for enrollment.
Does this trial require TSC1?
Yes, TSC1 loss-of-function mutation is a required biomarker for enrollment.
Does this trial require TSC2?
Yes, TSC2 deletion is a required biomarker for enrollment.
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 qualifyRelated pages