Advanced Solid TumorPhase 1NCT05183243
GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results
A Phase 1 study testing GH21 Capsule in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by Suzhou Genhouse Bio Co., Ltd. at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Pancreatic Cancer
- What is being tested?
- GH21 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 9 sitesChina
- Study dates
- 20 Feb 2022to 20 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Ning Li, Postdoctoral, （86）010-87788495, lining@cicams.ac.cn
- Recruiting
Beijing University Cancer Hospital
Beijing, Beijing Municipality, 100143
Lin Shen, Doctorate, （86）010-88121122, doctorshenlin@sina.cn
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality
Yongsheng Li, Doctorate, （86）023-65301682, lys@cqu.edu.cn
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Haiping Jiang, Doctorate, （86）0571-87236685, Jianghaiping75@163.com
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000
Mingjun Zhang, Master, （86）0551-63869529, mjzhang2010@outlook.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317099
Jianying Jin, Master, （86）0576-85120120, 302861459@qq.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yongsheng Wang, Doctorate, （86）025-83304616, dolphin8012@yahoo.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Suxia Luo, Doctorate, （86）0371-65588251, luosxrm@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xingya Li, Doctorate, （86） 0371-67966263, lixingyavip@163.com
About this study
Official title: 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
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.
- Conditions
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Head and Neck Neoplasm
- Being tested
- GH21 Capsule
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH21 CapsuleDrug
GH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation. | Experimental | Treatment with GH21 alone, conducted until disease progression, intolerance or end of study. Receives: Drug: GH21 Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose (MTD) of GH21.
MTD is the highest dose of a treatment that does not cause unacceptable side effects.
Measured: 28 Days
Characterize the Safety of GH21
Number of participants with treatment-emergent adverse events and serious AEs.
Measured: Approximately 3 years
Secondary outcomes (8)
Objective Response Rate (ORR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
Progression-Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Approximately 3 years
PD of GH21
Change of phosphorylated ERK
Measured: Approximately 3 years
Cmax
The maximum or "peak" concentration of GH21 observed after administration
Measured: Approximately 3 years
Tmax
The time to peak concentration of GH21
Measured: Approximately 3 years
T1/2
Half-life of GH21
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start20 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haidan Wang, Doctorate, Study director, 0512-86861608
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183243
- Sponsor's protocol ID
- GH21-CRS001
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2021
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO plan
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05183243
- Acronym / sponsor ID
- GH21-CRS001
- Conditions
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Head and Neck Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation. | Experimental | Drug: GH21 CapsuleTreatment with GH21 alone, conducted until disease progression, intolerance or end of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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 %;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GH21 CapsuleGH21 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F. | Drug | Monotherapy Dose Escalation. |
Primary outcome
Determination of Maximum Tolerated Dose (MTD) of GH21.
Time frame: 28 Days
MTD is the highest dose of a treatment that does not cause unacceptable side effects.
Characterize the Safety of GH21
Time frame: Approximately 3 years
Number of participants with treatment-emergent adverse events and serious AEs.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 3 years
Disease Control Rate (DCR)
Time frame: Approximately 3 years
Duration of Response (DOR)
Time frame: Approximately 3 years
Progression-Free Survival (PFS)
Time frame: Approximately 3 years
PD of GH21
Time frame: Approximately 3 years
Cmax
Time frame: Approximately 3 years
Tmax
Time frame: Approximately 3 years
T1/2
Time frame: Approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No. NO plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidan Wang, Doctorate study director
0512-86861608
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GH21 Capsule in people with Advanced Solid Tumor and Non-Small Cell Lung Cancer, run by Suzhou Genhouse Bio Co., Ltd. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiming Zhou, Bachelor (0521-86861608, zhouyiming@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Tolerated Dose (MTD) of GH21. (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.