Study to Evaluate D-1553 in Subjects With Lung Cancer

NCT05383898 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: D1553-102
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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

Conditions

NSCLC

Outcome Measures

Primary Outcomes (3)

• Subject incidence of Dose-limiting toxicities (DLT)

  Subject incidence of Dose-limiting toxicities (DLT)

  through out the DLT period, approximately 21 days

• Number of subjects participants with adverse events

  Number of subjects participants with adverse events

  Through 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 \[PR\])

  Through study completion, approximately 3 years

Secondary Outcomes (1)

• Plasma concentration of D-1553

  approximately 6 months

Study Arms (3)

Phase 1a Dose escalation of D-1553

EXPERIMENTAL

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

Drug: D-1553

Phase 1b Dose expansion of D-1553

EXPERIMENTAL

Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.

Drug: D-1553

Phase 2 of D-1553 monotherapy

EXPERIMENTAL

Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy.

Drug: D-1553

Interventions

D-1553 DRUG

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 1a Dose escalation of D-1553; Phase 1b Dose expansion of D-1553; Phase 2 of D-1553 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,

Hangzhou, Zhejiang, 310005, China

Location

Related Publications (3)

• 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. 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 DERIVED

• 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.

  PMID: 38870979 DERIVED

• 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.

  PMID: 36948246 DERIVED

Study Officials

• Shun Lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 20, 2022
• Study Start: March 16, 2021
• Primary Completion: November 17, 2023
• Study Completion: May 17, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)