Actively Recruiting
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral GH21 Capsules Combined With Osimertinib Mesylate Tablets in Advanced NSCLC Patients With EGFR Mutations
Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2024-07-08
94
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and effectiveness of GH21 capsules combined with Osimertinib mesylate tablets in patients with advanced non-small cell lung cancer (NSCLC) that has EGFR mutations. This study includes phase Ib, phase IIa, and phase IIb stages to determine the recommended dose and assess how patients respond to this combination treatment. In phase Ib, a classic "3+3" design is used to select dose levels with four preset dose groups including once daily (QD) and twice weekly (BIW) dosing schedules. Phase IIa consists of two cohorts receiving different doses of GH21 combined with Osimertinib 80 mg QD, while phase IIb involves one cohort where dose and treatment decisions are based on safety, efficacy, and PK data from earlier phases. Participants will be monitored for adverse events, dose-limiting toxicities, and progression-free survival over two years. Assessments include tumor measurements using RECIST 1.1 criteria, genetic testing, survival rates, and plasma drug concentration levels. The study also tracks overall safety, treatment response, and pharmacokinetics to understand how the drugs behave in the body during and after treatment.
CONDITIONS
Brief Title
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects or their legal representatives can understand and voluntarily sign the written informed consent form.
- Male or female subjects aged 18 years or older.
- Advanced NSCLC patients with confirmed EGFR mutations.
- For Phase Ib, patients must have disease progression after treatment with third-generation EGFR-TKIs and platinum-containing chemotherapy.
- For Phase IIa and IIb, patients must have disease progression after treatment with third-generation EGFR-TKIs.
- At least one measurable lesion by RECIST v1.1.
- Consent to provide samples for genetic testing.
- Life expectancy of at least 3 months.
- ECOG performance status score of 0-1.
- Adequate organ functions.
- Male and female of reproductive potential agree to reliable contraception from signing consent until 30 days after last dose, with negative pregnancy test for females within 7 days prior to first dose.
You will not qualify if you...
- Chemotherapy or antitumor biologics within 3 weeks prior to first dose, or radiotherapy/endocrine therapy within 4 weeks prior (with some exceptions).
- Prior investigational new drug or therapy within 4 weeks before first dose.
- Major organ surgery or significant trauma within 4 weeks before first dose.
- Use of strong CYP3A4 or P-gp inhibitors or inducers within 2 weeks or 5 half-lives prior to first dose.
- Recent serious heart conditions or uncontrolled hypertension.
- Dysphagia, gastrointestinal disorders affecting drug absorption, or severe unresolved GI toxicities.
- Poorly controlled pleural effusion.
- Active central nervous system metastasis or carcinomatous meningitis.
- Interstitial pneumonia or active interstitial lung disease within 6 months prior to first dose.
- History of other malignancies except certain cured cancers.
- History of severe allergies or allergy to Osimertinib.
- Hepatitis B or C infection or HIV infection.
- Active infections requiring treatment or fever above 38°C within 28 days prior to first dose.
- Unresolved toxicity from prior antitumor therapy above certain grades.
- Pregnant or breastfeeding females.
- Any clinical or laboratory abnormalities or other reasons assessed by investigator making participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive oral GH21 capsules combined with Osimertinib mesylate tablets as part of the study treatment.
Visits occur regularly during study treatment; exact schedule depends on study phase and cohort assignment
Trial Site Locations
Total: 6 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Not Yet Recruiting
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
3
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
4
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
5
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
6
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China, 317099
Actively Recruiting
Research Team
Y
Yiming Zhou, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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