Non-Small Cell Lung Cancer With EGFR MutationPhase 1/2NCT06306456
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
A Phase 1/2 study testing GH21 and Tagrisso in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Suzhou Genhouse Bio Co., Ltd. at 6 sites in China.
Trial summary
This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer With EGFR Mutation
- What is being tested?
- GH21 and Tagrisso
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesChina
- Study dates
- 5 Mar 2024to 31 Dec 2026
- 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
- Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
- Male or female subjects aged ≥18 years;
- Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:
- Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;
- Phase IIa and IIb：patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.).
- Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
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- Consent to provide samples for genetic testing;
- Life expectancy of ≥ 3 months;
- ECOG PS score of 0-1;
- The subjects must have adequate organ functions;
- Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.
Who cannot join
- Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:
- Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;
- Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);
- Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);
- Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product;
- Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;
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- Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;
- Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product;
- Subjects with evidence of the following heart conditions:
- Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;
- Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;
- Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;
- QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;
- Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;
- Subjects with poorly controlled clinical pleural ascites assessed by the investigator;
- Subjects with active central nervous system metastasis and/or carcinomatous meningitis (e.g., brain metastases accompanied by central nervous system symptoms, including headache, vomiting and dizziness, etc.);
- Subjects with interstitial pneumonia, or any evidence of clinically active interstitial lung disease within 6 months before the first dose of the investigational product;
- Subjects with a history of other malignancies (excluding those deemed eligible by the investigator, such as skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been cured and have not relapsed for 5 years; or subjects deemed eligible by the investigator in Phase Ib);
- Subjects with a history of severe allergies, a history of allergies to Osimertinib, or to multiple drugs;
- Subjects with hepatitis B virus infection (HBsAg positivity and DNA copies < 100 IU/mL); or hepatitis C virus infection (HCV antibody positivity, and HCV RNA > ULN); or human immunodeficiency virus infection (HIV antibody positivity);
- Subjects with active infections requiring anti-infective treatment (Grade ≥ 2) or fever > 38°C of unknown etiology within 28 days prior to the first dose of the investigational product;
- Subjects with any toxicity caused by a previous antitumor therapy that has not resolved to Grade ≤ 1 according to CTCAE 5.0 (except for alopecia, Grade 2 peripheral neuropathy, and/or other Grade ≤ 2 AEs of insignificant safety risks) before the first dose of the investigational product;
- Female subjects who are pregnant or breastfeeding;
- Subjects who are not suitable for this study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Yongchang Zhang, Doctorate, (86)0731-88651900, zhangyongchang@csu.edu.cn
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Mingjun Zhang, Doctorate, (86)0551-63869420, mjzhang2010@outlook.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317099
Dongqing Lv, Master's degree, （86）0576-85120120, lvdq@enzemed.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yongsheng Wang, Doctorate, （86）025-83304616, dolphin8012@yahoo.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, Doctorate, （86）021-65115006, caicunzhoudr@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Sanxing Guo, Doctorate, (86)0371-67966266, sanxing134@hotmail.com
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations
This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.
Read the detailed description
Phase Ib: Classic "3+3" design used for Phase 1b to select the putative RDEs. Four dose groups are preset in phase Ib of this study, which including QD groups and BIW groups. Subjects will be enrolled in parallel cross into the group.
Phase IIa: Two cohorts are preset in this stage, Cohort 1: GH21 RDE1 QD + Osimertinib 80 mg QD, Cohort 2: GH21 RDE2 D1D2-BIW + Osimertinib 80 mg QD, Cohort 1 and Cohort 2 are enrolled in parallel.
Phase IIb: Phase IIb preset 1 cohort. The investigator and sponsor will comprehensively evaluate safety, efficacy, and PK data from Phases Ib and IIa to determine the dose level for Phase IIb.
- Being tested
- GH21, Tagrisso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH21Drug
Oral, 15mg BIW/6mg QD
TagrissoDrug
Oral, 80mg QD
| Study group | Role | What they receive |
|---|---|---|
| 'GH21+Osimertinib'Group | Experimental | GH21 Capsules Combined with Osimertinib Mesylate Tablets Receives: Drug: GH21; Drug: Tagrisso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (phase Ib)
Measured: 2 years
Number of Participants with Adverse Events
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, electrocardiograms, cardiac imaging and ophthalmological assessments (phase Ib/ IIa)
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. (phase IIb)
Measured: 2 years
Secondary outcomes (7)
Objective 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). (phase Ib/IIa/IIb)
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. (phase Ib/IIa/IIb)
Measured: 2 years
Disease Control Rate (DCR) Based on RECIST 1.1 Criteria
DCR is defined as the proportion of patients in a clinical trial whose cancer shrinks or remains stable over a certain period.
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 (phase Ib/IIa/IIb)
Measured: 2 years
Plasma Peak Concentration (Cmax)
Highest observed plasma concentration of GH21 and Osimertinib. (phase Ib/IIa/IIb)
Measured: 2 years
Time to Cmax (Tmax)
Time of highest observed plasma concentration of GH21 and Osimertinib. (phase Ib/IIa/IIb)
Measured: 2 years
Area under the Plasma Concentration-Time Curve (AUC)
Area under the plasma concentration time curve of GH21 and Osimertinib. (phase Ib/IIa/IIb)
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 posted12 Mar 2024
- Study start5 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer With EGFR 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Doctorate, Principal investigator, （86）021-65115006Haidan Wang, Doctorate, Study director, （86）0512-86861608
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306456
- Sponsor's protocol ID
- GH21C201
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations
- ClinicalTrials.gov ID
- NCT06306456
- Acronym / sponsor ID
- GH21C201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Suzhou Genhouse Bio Co., Ltd.University, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 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 study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.
Detailed description
Phase Ib: Classic "3+3" design used for Phase 1b to select the putative RDEs. Four dose groups are preset in phase Ib of this study, which including QD groups and BIW groups. Subjects will be enrolled in parallel cross into the group.
Phase IIa: Two cohorts are preset in this stage, Cohort 1: GH21 RDE1 QD + Osimertinib 80 mg QD, Cohort 2: GH21 RDE2 D1D2-BIW + Osimertinib 80 mg QD, Cohort 1 and Cohort 2 are enrolled in parallel.
Phase IIb: Phase IIb preset 1 cohort. The investigator and sponsor will comprehensively evaluate safety, efficacy, and PK data from Phases Ib and IIa to determine the dose level for Phase IIb.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'GH21+Osimertinib'Group | Experimental | Drug: GH21, Drug: TagrissoGH21 Capsules Combined with Osimertinib Mesylate Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
- Male or female subjects aged ≥18 years;
- Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:
- Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);
- Consent to provide samples for genetic testing;
Key exclusion criteria (25 listed)
- Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:
- Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;
- Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;
- Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product;
- Subjects with evidence of the following heart conditions:
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 |
|---|---|---|
| GH21Oral, 15mg BIW/6mg QD | Drug | 'GH21+Osimertinib'Group |
| TagrissoOral, 80mg QD | Drug | 'GH21+Osimertinib'Group |
Primary outcome
Number of Participants with Dose Limiting Toxicities
Time frame: 2 years
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (phase Ib)
Number of Participants with Adverse Events
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, electrocardiograms, cardiac imaging and ophthalmological assessments (phase Ib/ IIa)
Progression-Free Survival (PFS) Based on RECIST 1.1 Criteria
Time frame: 2 years
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. (phase IIb)
7 secondary outcomes
Objective 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
Overall Survival (OS)
Time frame: 2 years
Plasma Peak Concentration (Cmax)
Time frame: 2 years
Time to 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.
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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.
Caicun Zhou, Doctorate principal investigator
（86）021-65115006
Haidan Wang, Doctorate study director
（86）0512-86861608
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GH21 and Tagrisso in people with Non-Small Cell Lung Cancer With EGFR Mutation, run by Suzhou Genhouse Bio Co., Ltd. at 6 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 11 inclusion and 25 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: looking for participants now, 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 6 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 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 Yiming Zhou, Bachelor (（86）0512-86861608, zhouyiming@genhousebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (time frame: 2 years). The study lists 3 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.