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NCT04478279PHASE1, PHASE2ACTIVE_NOT_RECRUITING

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors

A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors

Sponsor: Sapience Therapeutics

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Glioblastoma, Melanoma Stage IV, Breast Cancer, Prostate Cancer, Glioblastoma Multiforme
Interventions
ST101, Temozolomide, Radiation
Enrollment
125 participants
Primary completion
Dec 2026
Study completion
Dec 2026
First posted
Jul 2020
Last updated
Feb 2026

Primary Endpoints (CT.gov)

Dose-Limiting Toxicity (DLT)

Time frame: 20 months

Adverse Events

Time frame: 20 months

Secondary Endpoints

Area Under the Curve (AUC)

Cmax

Terminal Half-Life (t1/2)

Eligibility Criteria

Inclusion Criteria: * Inclusion Criteria 1. Able and willing to sign informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein. 2. Male or female ≥18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Must have a locally advanced or metastatic inoperable tumor as follows: 1. For the dose escalation/regimen exploration phase: melanoma, carcinoma, or sarcoma 2. For the expansion phase: HR positive LA/MBC, melanoma, GBM, CRPC 5. Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated (unless progressing following irradiation), but a new or progressing lesion in the radiation field is acceptable. Archived biopsies are acceptable for GBM patients. 6. In the invest

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov