A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors

NCT06329206 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-07-08

No results posted yet for this study

Summary

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Conditions

Interventions

DRUG

GH2616 Tablets

GH2616 tablets will be given orally

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    collaborator OTHER
  • Henan Cancer Hospital

    collaborator OTHER_GOV
  • Hubei Cancer Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Suzhou Genhouse Bio Co., Ltd.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2026-04-25
Completion
2026-09-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

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 NCT06329206 on ClinicalTrials.gov