APPROVED_FOR_MARKETINGNot Applicable

Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation

Plain-language summary

Expanded Access for an Intermediate-size Population for ABI-009 (Sirolimus Albumin-bound Nanoparticles for Injectable Suspension) in Patients with Advanced Perivascular Epithelioid Cell Tumors (PEComa) and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. a) Diagnosis of advanced (locally advanced and inoperable or metastatic) malignant PEComa confirmed by pathology and immunohistochemistry, whether or not previously exposed to an mTOR inhibitor, or b) diagnosis of any other malignancy with activation in any mTOR pathway component as identified by immunohistochemistry or an identified relevant rare genetic mutation in mTOR pathway genes, including but not limited to TSC1, TSC2, PIK3CA, PTEN, for which there are no FDA-approved treatments or no other comparable or satisfactory alternative therapies available whether or not they been previously exposed to a mTOR inhibitor.
✓. 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
✓. Acceptable blood chemistry levels at screening (obtained ≤14 days prior to enrollment (local laboratory) including:
✓. total bilirubin ≤1.5 x upper limit of normal (ULN)
✓. AST ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)
✓. serum creatinine ≤1.5 x ULN
✓. Adequate biological parameters as demonstrated by the following blood counts at screening (obtained ≤14 days prior to enrollment, local laboratory):
✓. Absolute neutrophil count (ANC) ≥1.5 × 109/L;

Exclusion criteria

✕. Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA \<0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥1 year.
✕. In the treating physician's opinion, the potential risks outweigh the potential benefits of therapy with ABI-009.
✕. Prior exposure to ABI-009.

Trial details

NCT IDNCT03817515

SponsorAadi Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More PEComa, Malignant trials