Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C MutationPhase 1/2NCT06435455
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors
A Phase 1/2 study testing GH21 and D-1553 in people with Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation, run by Suzhou Genhouse Bio Co., Ltd..
Trial summary
This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
- What is being tested?
- GH21 and D-1553
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
- Age ≥18 years old, male or female;
- KRAS G12C mutant advanced solid tumor;
- ECOG Performance Status of 0 or 1
- At least one measurable lesion as defined by RECIST 1.1
Who cannot join
- acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;
- Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
- There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
- Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
- Pregnant and lactating women;
- The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.
Read the detailed description
This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.
- Being tested
- GH21, D-1553
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH21Drug
GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule
D-1553Drug
D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet
| Study group | Role | What they receive |
|---|---|---|
| "GH21 + D-1553" Group | Experimental | GH21 capsules combined with D-1553 tablets were administrated orally Receives: Drug: GH21; Drug: D-1553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicities Incidence Count Among Study
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.
Measured: 2 years
Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc
Measured: 2 years
Secondary outcomes (8)
response rate (ORR) based on RECIST 1.1 criteria
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: 2 years
Duration of response (DOR) based on RECIST 1.1 criteria
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Measured: 2 years
Disease Control Rate (DCR) based on RECIST 1.1 criteria
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Measured: 2 years
Progression-free survival (PFS) based on RECIST 1.1 criteria
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
Measured: 2 years
Overall survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor
Measured: 2 years
Plasma concentration (Cmax)
Peak Plasma concentration
Measured: 2 years
Time to achieve Cmax (Tmax)
Time to achieve Cmax
Measured: 2 years
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid Tumors Harboring KRAS 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435455
- Sponsor's protocol ID
- GH21C203
- Status last verified
- Jul 2024
- First submitted
- 24 May 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT06435455
- Acronym / sponsor ID
- GH21C203
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 May 2024 (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.
This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.
Detailed description
This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "GH21 + D-1553" Group | Experimental | Drug: GH21, Drug: D-1553GH21 capsules combined with D-1553 tablets were administrated orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
- Age ≥18 years old, male or female;
- KRAS G12C mutant advanced solid tumor;
- ECOG Performance Status of 0 or 1
- At least one measurable lesion as defined by RECIST 1.1
Key exclusion criteria (6 listed)
- acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;
- Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
- There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
- Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
- Pregnant and lactating women;
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 |
|---|---|---|
| GH21GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule | Drug | "GH21 + D-1553" Group |
| D-1553D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet | Drug | "GH21 + D-1553" Group |
Primary outcome
Dose-limiting Toxicities Incidence Count Among Study
Time frame: 2 years
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.
Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective
Time frame: 2 years
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc
8 secondary outcomes
response rate (ORR) based on RECIST 1.1 criteria
Time frame: 2 years
Duration of response (DOR) based on RECIST 1.1 criteria
Time frame: 2 years
Disease Control Rate (DCR) based on RECIST 1.1 criteria
Time frame: 2 years
Progression-free survival (PFS) based on RECIST 1.1 criteria
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Plasma concentration (Cmax)
Time frame: 2 years
Time to achieve Cmax (Tmax)
Time frame: 2 years
Area under the plasma concentration-time curve (AUC)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GH21 and D-1553 in people with Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation, run by Suzhou Genhouse Bio Co., Ltd..
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 5 inclusion and 6 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: opening soon, 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.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieqi Tang, bachelor (+8613311557758, tangjieqi@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicities Incidence Count Among Study (time frame: 2 years). 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 8 Jul 2024.