A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492045
• Other study ID #: D1553-105
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

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