A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Genuine Biotech Co., Ltd.
About this trial
This is an open-label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or metastatic EGFR-mutant non-small cell lung cancer.
Eligibility criteria
Qualifiers
18-75 years old (including 18 and 75 years old), male or female.
Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to curative surgery or radiotherapy. (For subjects naive to EGFR-TKI therapy, paraffin-embedded tissue blocks, unstained slides, or fresh tumor tissue samples must be available for EGFR testing.)
Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are recommended.)
a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed). Patients who have received prior neoadjuvant, adjuvant, and/or radical concurrent/sequential chemoradiotherapy (including chemotherapy, immunotherapy, targeted therapy, etc.) must have documented disease recurrence or progression within <6 months of completing the last regimen. b) Phase Ⅱa Dose Expansion Stage: Cohort 1: NSCLC patients with disease progression on a prior third-generation EGFR-TKI. Cohort 2: EGFR mutant NSCLC patients who are EGFR-TKI-naive.
Disqualifiers
Undergone major surgery within 4 weeks prior to the first administration;
Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration; for oral small-molecule targeted drugs, within 2 weeks or within 5 half-lives prior to the first administration (whichever is shorter);
Radiation therapy involving >30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration;
Strong inhibitors or inducers of CYP3A4 within 7 days prior to the first administration;
Trial design
Treatments tested in this trial
- GEN-725 tablets + Dositinib mesylate tablets
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov