A Phase 2 interventional study of nab-sirolimus in Tumor, Tumor, Solid and Metastasis, sponsored by Aadi Bioscience, Inc.. Active, not recruiting at 166 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Aadi Bioscience, Inc. · Phase 2, Interventional, and Treatment
A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
Study TSC-007 is a prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. Patients will be treated with single agent IV nab-sirolimus until disease progression, or unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion.
Patients must have a malignant solid tumor with a pathogenic inactivating TSC1 or TSC2 alteration. Genetic alterations should be identified using NGS in tumor tissue or liquid biopsy).
Adequate liver function:
Adequate hematologic parameters:
Male or non-pregnant and non-breastfeeding female:
Exclusion Criteria:
Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
Patients with pathogenic inactivating TSC1 alterations.
Drug: nab-sirolimus
Patients with pathogenic inactivating TSC2 alterations.
Drug: nab-sirolimus
Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients
Also known as: ABI-009
Overall response rate (ORR)
ORR based on the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until disease progression as determined by IRR using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 9 months
Duration of response (DOR)
Determined for patients with BOR of confirmed CR or PR (by IRR)
Time frame: 9 months
Disease control rate
BOR of confirmed CR or PR (either of any duration) or stable disease (SD) following study treatment initiation (by IRR)
Time frame: 9 months
Time to response
Time from first dose of study drug to initial measurement of CR or PR, where CR or PR is subsequently confirmed
Time frame: 9 months
Progression-free survival
Number of months from study treatment initiation to the date of disease progression (by IRR) or death due to any cause
Time frame: 9 months
Overall survival
Number of months from study treatment initiation to the date of death due to any cause
Time frame: 24 months
Patient-reported outcome
Changes from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire v3.0 (EORTC-QOQ-C30) scores
Time frame: 9 months
Incidence and severity of treatment-emergent and treatment-related adverse events (AEs)
Incidence and severity of treatment-emergent and treatment-related AEs as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: 9 months
Showing the first 100 of 166 sites across 3 countries.
Plan to share: No
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This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Aadi Bioscience, Inc.