Study to Evaluate D-1553 in Subjects With Lung Cancer

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05383898
• Other study ID #: D1553-102
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 16, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: InventisBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: June 30, 2024
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

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	Through 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])	Through study completion, approximately 3 years
Secondary	Plasma concentration of D-1553	Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation	approximately 6 months