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Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

NCT05221320 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-09-25

Study results available
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Summary

This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.

Conditions

Interventions

DRUG

Ulixertinib

small molecule ERK 1/2 inhibitor

DRUG

Hydroxychloroquine

Autophagy inhibitor

Sponsors & Collaborators

  • BioMed Valley Discoveries, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2024-05-08
Completion
2024-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05221320 on ClinicalTrials.gov