Advanced Solid Tumors Harboring With G12C MutationPhase 1NCT05010694
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
A Phase 1 study testing GH35 Tablet in people with Advanced Solid Tumors Harboring With G12C Mutation, run by Suzhou Genhouse Bio Co., Ltd. at 2 sites in China.
Trial summary
Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors Harboring With G12C Mutation
- What is being tested?
- GH35 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 27 Sep 2021to 12 Dec 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.
- Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
- Expected survival time ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Have documented disease progression or intolerance after first-line treatment.
Who cannot join
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Previous accept with KRAS G12C inhibitor.
- Uncontrollable general infection.
- Serious cardiovascular disease.
- Left ventricular ejection fraction (LVEF) <50 %.
- Known history of hypersensitivity to any of the excipients of GH35 tablets
- Pregnant or nursing (lactating) women.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors
Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.
- Being tested
- GH35 Tablet
- Keywords
- Advanced Solid Tumors, KRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH35 TabletDrug
GH35 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 GH35 alone, conducted until disease progression, intolerance or end of study. Receives: Drug: GH35 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Number of participants with dose limiting toxicities (DLTs)
Measured: 24 Days
Secondary outcomes (6)
Characterize the safety of GH35 in subjects
Number of participants with treatment-emergent adverse events
Measured: 30 Months
Pharmacokinetics of GH35
Blood plasma concentration
Measured: 1 Month
Objective response rate (ORR) as defined by RECIST 1.1 criteria
Measured: 30 Months
Duration of response (DOR) as defined by RECIST 1.1 criteria
Measured: 30 Months
Progression-free survival (PFS) as defined by RECIST 1.1 criteria
Measured: 30 Months
Disease control rate (DCR) as defined by RECIST 1.1 criteria
Measured: 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start27 Sep 2021
- Primary completion22 Mar 2023
- Study completion12 Dec 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 Tumors Harboring With G12C MutationStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baohui Han, Professor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010694
- Sponsor's protocol ID
- GH35-CRS001
- Status last verified
- May 2024
- First submitted
- 11 Aug 2021
- Last updated
- 8 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05010694
- Acronym / sponsor ID
- GH35-CRS001
- Keywords
- Advanced Solid Tumors, KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 18 Aug 2021 (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 GH35 in patients with KRAS mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant 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: GH35 TabletTreatment with GH35 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.
- Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
- Expected survival time ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Key exclusion criteria (7 listed)
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Previous accept with KRAS G12C inhibitor.
- Uncontrollable general infection.
- Serious cardiovascular disease.
- 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 |
|---|---|---|
| GH35 TabletGH35 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
Dose-limiting toxicities (DLT)
Time frame: 24 Days
Number of participants with dose limiting toxicities (DLTs)
6 secondary outcomes
Characterize the safety of GH35 in subjects
Time frame: 30 Months
Pharmacokinetics of GH35
Time frame: 1 Month
Objective response rate (ORR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Duration of response (DOR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Progression-free survival (PFS) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Disease control rate (DCR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Baohui Han, Professor principal investigator
Shanghai Chest Hospital
2 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 GH35 Tablet in people with Advanced Solid Tumors Harboring With G12C Mutation, run by Suzhou Genhouse Bio Co., Ltd. at 2 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 7 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 8 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 2 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: 24 Days). 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 8 Jul 2024.