A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib

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.

Trial Details

NCT ID
NCT07362940
Phase
PHASE1 / PHASE2
Sponsor
Henan Genuine Biotech Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • GEN-725 tablets + Dositinib mesylate tablets
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Changsha, China|28.19874,112.97087
  • Jinan, China|36.66833,116.99722
  • Xiamen, China|24.47979,118.08187
  • Zhengzhou, China|34.75778,113.64861

Key Eligibility Criteria

  • 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 c…
  • Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are…
  • a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy…

For full eligibility, visit ClinicalTrials.gov.

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