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GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results

NCT06310382 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-07-08

No results posted yet for this study

Summary

This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.

This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.

Conditions

  • Advanced Solid Tumors With MAPK Signal Pathway Mutations

Interventions

DRUG

GH55

GH55 capsule is a novel small molecule, highly selective dual-mechanism ERK1/2 inhibitor developed by Suzhou Genhouse Bio. Co., Ltd. This product can be used to treat cancers caused by abnormal activation of the MAPK pathway (mutational activation of RAS/RAF/MEK) by targeted inhibition of ERK1/2.

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Shandong Tumor Hospital

    collaborator OTHER

  • Suzhou Genhouse Bio Co., Ltd.

    lead OTHER

Principal Investigators

  • JIN LI, DPCTORATE · 021-38804518

  • HAIDAN WANG, DOCTORATE · 0512-86861608

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2025-05-26
Completion
2025-08-04
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT06310382 on ClinicalTrials.gov