GH21 Capsules for treating advanced solid tumors

A Multicenter, Open-label Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GH21 Capsules in Subjects With Advanced Solid Tumors

This study is testing GH21 capsules to see if they are safe and how much can be taken by people with advanced solid tumors like lung, pancreatic, colorectal, and head and neck cancers.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Genhouse Bio Co., Ltd. (other)
• Locations: 9 sites (Hefei, Anhui and 8 other locations)
• Trial ID: NCT05183243 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of GH21 capsules in patients with advanced solid tumors, including non-small cell lung cancer, pancreatic cancer, colorectal cancer, and head and neck neoplasms. The study aims to estimate the maximum tolerated dose (MTD) of GH21 in this patient population. Participants will undergo assessments to monitor their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced or metastatic solid tumors and a life expectancy of at least three months.

Not a fit: Patients with central nervous system metastases or those who have had prior treatment with SHP2 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new treatments.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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;
2. Have central nervous system metastases;
3. Prior treatment with SHP2 inhibitor;
4. Have major surgery within 28 days prior to the first dose of GH21;
5. Left ventricular ejection fraction (LVEF) \<50 %;
6. Females who are pregnant or breastfeeding ;
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

Where this trial is running

Hefei, Anhui and 8 other locations

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing, China (RECRUITING)
• Beijing University Cancer Hospital — Beijing, Beijing, China (RECRUITING)
• Chongqing Cancer Hospital — Chongqing, Chongqing, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (RECRUITING)
• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
• Taizhou Hospital of Zhejiang Province — Linhai, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yiming Zhou, Bachelor

Conditions: Advanced Solid Tumor, Non-Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Head and Neck Neoplasm