A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

Sponsor
Suzhou Genhouse Bio Co., Ltd.
Study ID
NCT06306456
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Non-Small Cell Lung Cancer With EGFR Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GH21 — DRUG
    Oral, 15mg BIW/6mg QD
  • Tagrisso — DRUG
    Oral, 80mg QD

Study Details

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.

Key Dates

Start date
Mar 5, 2024
Status verified
Feb 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
94 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 'GH21+Osimertinib'Group
    GH21 Capsules Combined with Osimertinib Mesylate Tablets

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities [ Time Frame: 2 years ]

Central Contacts