Clinical trial · Interventional
Study to Evaluate D-1553 in Subjects With Lung Cancer
A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors
NCT05383898CI-TRIAL-00081509completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 with advanced or metastatic NSCLC with KRasG12C mutation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-1553 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a Dose escalation of D-1553
- description
- 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
- interventionNames
- Drug: D-1553
- type
- EXPERIMENTAL
- label
- Phase 1b Dose expansion of D-1553
- description
- Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.
- interventionNames
- Drug: D-1553
- type
- EXPERIMENTAL
- label
- Phase 2 of D-1553 monotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (3)
- DERIVEDSong Z, Li Z, Zhang Y, Wang P, Jiang L, Zhao Y, Zhou J, Wang X, Zhuang W, Shi J, Huang D, Dang X, Cang S, Gong Y, Jin S, Li W, Dong X, Zhang J, Zhao M, Meng X, Liu X, Fang J, Wu P, Lu J, Zhang L, Yang J, Wang X, Luo H, Cui J, Zhang Z, Wang J, Li G, Wu L, Yu Y, Fang Y, Lv D, Yang W, Chen L, Yang N, Li K, Ma R, Wang M, Zhou H, Hu S, Li Q, Zhuang Z, Cao B, Zhu W, Xu C, Wang W, Xiang Z, Shi Z, Wang Y, Zhang L, Lu S. Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study. Eur J Cancer. 2026 Jan;232:116153. doi: 10.1016/j.ejca.2025.116153. Epub 2025 Nov 29. PMID 41330054
- DERIVEDLi 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. PMID 38870979
- DERIVEDLi 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. PMID 36948246