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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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);

• 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.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
The Second Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Taizhou Hospital of Zhejiang Province
RECRUITING
Linhai
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yiming Zhou, Bachelor
zhouyiming@genhousebio.com
(86)0512-86861608
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 94
Treatments
Experimental: 'GH21+Osimertinib'Group
GH21 Capsules Combined with Osimertinib Mesylate Tablets
Sponsors
Leads: Suzhou Genhouse Bio Co., Ltd.

This content was sourced from clinicaltrials.gov

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