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

NCT04478279 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-02-09

No results posted yet for this study

Summary

This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.

Conditions

Interventions

DRUG

ST101

ST101 will be administered intravenously (IV), initially once per week with a flat dose on the schedule described for each study arm

DRUG

Temozolomide

Temozolomide

RADIATION

Radiation

Radiation

Sponsors & Collaborators

  • Sapience Therapeutics

    lead INDUSTRY

Principal Investigators

  • Abi Vainstein-Haras, MD · CMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478279 on ClinicalTrials.gov