Status:
COMPLETED
Study to Evaluate D-1553 in Subjects With Lung Cancer
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects...
Eligibility Criteria
Inclusion
- Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
- Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
- Subject has measurable disease according to RECIST, v1.1
Exclusion
- Subject with unstable or progressive central nervous system (CNS) metastases.
- Subjects with clinically significant cardiovascular disease
- Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
- Subject is pregnant or lactating.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05383898
Start Date
March 16 2021
End Date
May 17 2024
Last Update
October 15 2024
Active Locations (2)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
2
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China, 310005