Clinical Trials Logo

Clinical Trial Summary

This is an open-label phase I/II preliminary study, including dose escalation, dose expansion, and efficacy expansion, to evaluate drug safety, tolerability, PK, and efficacy. The dose escalation study evaluates the IMP's safety, tolerability, and PK in patients with locally advanced or metastatic NSCLC who have experienced disease progression after third-generation EGFR-TKI therapy. The dose expansion study, after 2-3 dose levels are selected based on dose escalation results, further investigates the IMP's safety, tolerability, and PK, explores preliminary efficacy, and determines RP2D in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation. The efficacy expansion study evaluates the IMP's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR C797X mutation.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05662670
Study type Interventional
Source Suzhou Junjing BioSciences Co., Ltd.
Contact Yongdong Zhang
Phone +86 18042483763
Email yongdong_zhang@junshipharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 11, 2022
Completion date September 1, 2026

See also
  Status Clinical Trial Phase
Completed NCT03037086 - Asia PDL1 Study Among NSCLC Patients N/A
Active, not recruiting NCT03274479 - PBF-1129 in Patients With NSCLC Phase 1
Recruiting NCT03502850 - Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer Phase 1/Phase 2
Not yet recruiting NCT05990127 - A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer Phase 3
Active, not recruiting NCT03969823 - Whole Genomic Landscape of Advanced EGFR-mutant NSCLC N/A
Completed NCT04207775 - Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy
Completed NCT05631678 - Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole Phase 1
Not yet recruiting NCT06461156 - A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) Phase 1
Active, not recruiting NCT04143607 - ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC Phase 3
Completed NCT03414814 - Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation Phase 2
Completed NCT04360915 - Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects Phase 1