A Phase 1/2 interventional study of D-1553 and Other in NSCLC, sponsored by InventisBio Co., Ltd. Terminated at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by InventisBio Co., Ltd · Phase 1/2, Interventional, and Treatment
This is a Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 Combination Therapy in Subjects with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
InventisBio Co., Ltd is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Drug: D-1553 · Drug: Other
Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Drug: D-1553 · Drug: Other
D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation.
Standard treatment of NSCLC.
Subject incidence of Dose-limiting toxicities (DLT)
Subject incidence of Dose-limiting toxicities (DLT)
Time frame: Through out the DLT period, approximately 21 days
Number of subjects participants with adverse events
Number of subjects participants with adverse events
Time frame: Till study completion, approximately 3 years
Antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])
Time frame: Till study completion, approximately 3 years
Plan to share: No
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Garsorasib