Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
225 participants
INTERVENTIONAL
2021-03-16
2024-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose escalation of D-1553
Phase 1a will evaluate up to sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation
D-1553
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.
Phase 1b Dose expansion of D-1553
Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.
D-1553
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.
Phase 2 of D-1553 monotherapy
Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy.
D-1553
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.
Interventions
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D-1553
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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InventisBio Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shun Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China
Countries
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References
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Li Z, Dang X, Huang D, Jin S, Li W, Shi J, Wang X, Zhang Y, Song Z, Zhang J, Zhuang W, Liu X, Jiang L, Meng X, Zhao M, Zhou J, Zhang L, Wang P, Luo H, Yang J, Cang S, Wang X, Zhang L, Lu S; D1553-102 Study Group. Garsorasib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial. Lancet Respir Med. 2024 Aug;12(8):589-598. doi: 10.1016/S2213-2600(24)00110-3. Epub 2024 Jun 10.
Li Z, Song Z, Zhao Y, Wang P, Jiang L, Gong Y, Zhou J, Jian H, Dong X, Zhuang W, Cang S, Yang N, Fang J, Shi J, Lu J, Ma R, Wu P, Zhang Y, Song M, Xu CW, Shi Z, Zhang L, Wang Y, Wang X, Zhang Y, Lu S. D-1553 (Garsorasib), a Potent and Selective Inhibitor of KRASG12C in Patients With NSCLC: Phase 1 Study Results. J Thorac Oncol. 2023 Jul;18(7):940-951. doi: 10.1016/j.jtho.2023.03.015. Epub 2023 Mar 21.
Other Identifiers
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D1553-102
Identifier Type: -
Identifier Source: org_study_id
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