Trial intelligence / Profile preview

THE-630 in Advanced GIST

NCT05160168Phase 2

Key facts

Status: Terminated
Start: Jan 2022
Primary completion: Feb 2024
Countries: 1
Sponsor: Theseus Pharmaceuticals
Modality: Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders

Drugs: THE-630
Conditions: gastrointestinal stromal tumor (GIST)

Overview

Phase 2, open-label trial of THE-630 in gastrointestinal stromal tumor (GIST) (4 arms), sponsored by Theseus Pharmaceuticals. Primary endpoints: Treatment-emergent Adverse Events up to 24 months, Dose-limiting Toxicities at 28 days and 3 more. Started Jan 2022; status: terminated.

Design

4 arms

Study design: Non-randomizedOpen-label

Dose Escalation
Phase 1: Patients with unresectable or metastatic GIST receiving escalating doses of THE-630.
Expansion Cohort 1
Phase 2: Patients (>=5th line) receiving THE-630 at RP2D.
Expansion Cohort 2
Phase 2: Patients (3rd-4th line) receiving THE-630 at RP2D.
Expansion Cohort 3
Phase 2: Patients (2nd line) receiving THE-630 at RP2D.

Who it enrols

Patients must have histologically confirmed unresectable or metastatic GIST and must have progressed on or be intolerant to imatinib. Depending on the cohort, prior treatment with sunitinib, regorafenib, ripretinib, or avapritinib is also required. Patients known to be both KIT and PDGFRA wild-type are excluded.

Endpoints

Primary

Treatment-emergent Adverse EventsUp to 24 months
Dose-limiting Toxicities28 days
Maximum Tolerated Dose28 days
Recommended Phase 2 Dose28 days
Objective Response RateUp to 24 months

Secondary

Maximum Observed ConcentrationCycle 1 Day 15
Time to Maximum ConcentrationCycle 1 Day 15
Area Under the CurveCycle 1 Day 15
Best Overall ResponseUp to 24 months
Best Target Lesion ResponseUp to 24 months
Time to ResponseUp to 24 months
Duration of ResponseUp to 24 months
Disease Control RateUp to 24 months

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