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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
GH21
DrugOral, 15mg BIW/6mg QD
Tagrisso
DrugOral, 80mg QD
Treatment groups
94 Participants
are divided into 1 treatment groupGroup A: 'GH21+Osimertinib'GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (phase Ib)
Time frame
2 years2
Number of Participants with Adverse Events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (phase Ib/ IIa)
Time frame
2 years3
Progression-Free Survival (PFS) Based on RECIST 1.1 Criteria
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (phase IIb)
Time frame
2 yearsSecondary outcomes
1
Objective Response Rate (ORR) Based on RECIST 1.1 Criteria
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (phase Ib/IIa/IIb)
Time frame
2 years2
Duration of Response (DOR) Based on RECIST 1.1 Criteria
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (phase Ib/IIa/IIb)
Time frame
2 years3
Disease Control Rate (DCR) Based on RECIST 1.1 Criteria
DCR is defined as the proportion of patients in a clinical trial whose cancer shrinks or remains stable over a certain period.
Time frame
2 years4
Overall Survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor (phase Ib/IIa/IIb)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov