What is GH21 studying for non-small cell lung cancer with EGFR mutations?

GH21 is being studied in combination with Osimertinib mesylate tablets to evaluate their safety, how the body processes the drugs, and their effect on advanced NSCLC patients with EGFR mutations. The study aims to find the best dose and monitor treatment responses over time under the lead sponsor Suzhou Genhouse Bio Co., Ltd.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults aged 18 years or older with advanced NSCLC and confirmed EGFR mutations may be eligible. Both males and females can participate. Participants should have prior treatment with third-generation EGFR-TKIs and meet health and organ function requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive study treatments and monitoring without charge during the trial.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06306456

Phase IbII Study Evaluating Safety and Effectiveness of GH21 Capsules with Osimertinib Tablets in Adults with Advanced NSCLC and EGFR Mutations

Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2024-07-08

Participants Needed

Research Sites

52 weeks

Total Duration

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 33 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

Age: 18Years +

All Genders

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.

Research Team

Yiming Zhou, Bachelor

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Phase IbII Study Evaluating Safety and Effectiveness of GH21 Capsules with Osimertinib Tablets in Adults with Advanced NSCLC and EGFR Mutations

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria