NCT05183243

Brief Summary

Evaluate the safety and tolerability of GH21 in patients with advanced solid tumors. Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2022

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

July 16, 2024

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

December 21, 2021

Last Update Submit

July 11, 2024

Conditions

Advanced Solid TumorNon-Small Cell Lung CancerPancreatic CancerColorectal CancerHead and Neck Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Determination of Maximum Tolerated Dose (MTD) of GH21.

    MTD is the highest dose of a treatment that does not cause unacceptable side effects.

    28 Days

  • Characterize the Safety of GH21

    Number of participants with treatment-emergent adverse events and serious AEs.

    Approximately 3 years

Secondary Outcomes (8)

  • Objective Response Rate (ORR)

    Approximately 3 years

  • Disease Control Rate (DCR)

    Approximately 3 years

  • Duration of Response (DOR)

    Approximately 3 years

  • Progression-Free Survival (PFS)

    Approximately 3 years

  • PD of GH21

    Approximately 3 years

  • +3 more secondary outcomes

Study Arms (1)

Monotherapy Dose Escalation.

EXPERIMENTAL

Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.

Drug: GH21 Capsule

Interventions

GH21 CapsuleDRUG

GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.

Monotherapy Dose Escalation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects greater than or equal to 18 years old；
  • Written informed consent obtained prior to any study-related procedure being performed;
  • Subjects with life expectancy ≥3 months;
  • Eastern Cooperative Oncology Group performance score 0 - 2;
  • Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor;
  • At least one measurable lesion based on RECIST version 1.1 .

You may not qualify if:

  • History of other malignancies within 3 years before screening,unless radical non-melanoma skin cancer or basal cell carcinoma of the skin or carcinoma in the situ of the cervix;
  • Have central nervous system metastases;
  • Prior treatment with SHP2 inhibitor;
  • Have major surgery within 28 days prior to the first dose of GH21;
  • Left ventricular ejection fraction (LVEF) \<50 %;
  • Females who are pregnant or breastfeeding ;
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
  • Conditions that the investigator considers inappropriate for participation in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing University Cancer Hospital

Beijing, Beijing Municipality, 100143, China

RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317099, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungPancreatic NeoplasmsColorectal NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Haidan Wang, Doctorate

    0512-86861608

    STUDY DIRECTOR

Central Study Contacts

Yiming Zhou, Bachelor

CONTACT

0521-86861608zhouyiming@genhousebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 10, 2022

Study Start

February 20, 2022

Primary Completion

December 31, 2024

Study Completion

February 20, 2025

Last Updated

July 16, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

NO plan

Locations

CN(9)