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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05492045
Other study ID # D1553-105
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 13, 2022
Est. completion date December 2024

Study information

Verified date April 2023
Source InventisBio Co., Ltd
Contact Bingxin Xue
Phone (86)21-50663661
Email bingxin.xue@inventisbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date December 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject with histologically proven, locally advanced or metastatic NSCLC for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy. - 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 local laboratory. - Subject has measurable disease according to RECIST v1.1. For phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
Other
Standard treatment of NSCLC.

Locations

Country Name City State
China Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences Hangzhou Zhejiang
China Shanghai Chest Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject incidence of Dose-limiting toxicities (DLT) Subject incidence of Dose-limiting toxicities (DLT) Through out the DLT period, approximately 21 days
Primary Number of subjects participants with adverse events Number of subjects participants with adverse events Till study completion, approximately 3 years
Primary 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]) Till study completion, approximately 3 years
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