Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379946
• Other study ID #: D1553-106
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 12, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: InventisBio Co., Ltd
• Contact: Debo Nie
• Phone: (86)21-50663661
• Email: debo.nie[@]inventisbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• 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 solid tumor, 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 (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
• Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
• Subject has measurable disease according to RECIST, v1.1 Exclusion Criteria: Subject with unstable or progressive central nervous system (CNS) metastases.
• Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
• Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
• Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
• Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
• Subject is pregnant or lactating.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• D-1553
D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation
• IN10018
IN10018 orally once daily at approximately the same time each day

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
InventisBio Co., Ltd	InxMed (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	Number of subjects participants with adverse events	Through study completion, approximately 3 years
Primary	Objective response rate (ORR) per RECIST v1.1	Defined as the proportion of patients with complete response (CR) or partial response (PR).	Through study completion, approximately 3 years