A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Genhouse Bio Co., Ltd.
About this trial
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 criteria
Qualifiers
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;
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.).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GH21
- Tagrisso
Treatment groups
94 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov