Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-02-25
18
Participants Needed
1
Research Sites
337 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Aadi Bioscience
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions confirmed by genomic testing.
- Metastatic or unresectable sarcoma without effective standard curative options.
- One prior standard systemic therapy required for leiomyosarcoma patients.
- Prior gemcitabine-based chemotherapy allowed if last dose was over 12 months ago without disease progression during treatment and with intolerable toxicity.
- Measurable disease with at least one lesion measurable by imaging or clinical exam.
- Age 18 years or older.
- ECOG performance status of 2 or less (Karnofsky score 60% or higher).
- Life expectancy greater than 3 months.
- Adequate organ and marrow function as defined by specific blood count and chemistry levels.
- Undetectable hepatitis B viral load if on suppressive therapy.
- Hepatitis C infection must be treated and cured, or have undetectable viral load if currently on treatment.
- HIV infection with viral load under 400 copies/mL, no AIDS-defining illness within 12 months, and no use of CYP3A4 inducers or inhibitors in antiretroviral treatment.
- Treated brain metastases allowed if no progression on follow-up imaging.
- Cardiac function assessment must be New York Heart Association class 2B or better.
- Women of childbearing potential and men must agree to use effective contraception during the study.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Receiving or received investigational agents within 3 weeks prior to enrollment.
- History of allergic reactions to drugs similar to nab-sirolimus or gemcitabine.
- Use of strong CYP3A4 inhibitors or inducers, or narrow therapeutic window CYP3A4 substrates within 7 days before first dose.
- Active concurrent malignancy.
- Recent stroke or thromboembolic event within 6 months requiring anticoagulation that cannot be interrupted.
- Active gastrointestinal bleeding.
- Uncontrolled diabetes mellitus with HbA1c over 8% despite treatment.
- Severe or uncontrolled systemic disease or any condition limiting safe participation.
- Pregnant or breastfeeding women.
- Prior treatment of sarcoma with mTOR inhibitors.
- Vulnerable populations will not be enrolled.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elise Nassif, MD
CONTACT
G
Gracy Zacharian, BSN,MSN,RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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