Study to Evaluate D-1553 in Subjects With Lung Cancer

Conditions

NSCLC

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 with advanced or metastatic NSCLC with KRasG12C mutation

Yamamoto N, Yan D, Ganju V, Hou X, Pan H, Shan J, Wang L, Kim SW, Richardson G, Sanborn RE, Zhang J, Xiang Z, Wang W, Shi Z, Zhang L, Wang Y, Xu RH.

2025-12-04

10.1038/s41416-025-03286-w

Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study.

Song 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.

2025-11-29

10.1016/j.ejca.2025.116153

Garsorasib in patients with KRAS<sup>G12C</sup>-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial.

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.

2024-06-1025 citations

10.1016/s2213-2600(24)00110-3

Interventions

DRUGD-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Subject incidence of Dose-limiting toxicities (DLT)	through out the DLT period, approximately 21 days	Subject incidence of Dose-limiting toxicities (DLT)
Number of subjects participants with adverse events	Through study completion, approximately 3 years	Number of subjects participants with adverse events
antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation	Through study completion, approximately 3 years	Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])

Secondary

Measure	Time frame	Description
Plasma concentration of D-1553	approximately 6 months	Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation

Countries

China

Outcome results

None listed