Study to Evaluate D-1553 in Subjects With Lung Cancer

Phase 1

Completed

• Conditions: NSCLC
• Interventions: Drug: D-1553

• Registration Number: NCT05383898
• Lead Sponsor: InventisBio Co., Ltd

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-16
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Primary Completion: 2023-11-17
• Study Completion: 2024-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1a Dose escalation of D-1553	D-1553	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
Phase 1b Dose expansion of D-1553	D-1553	Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.
Phase 2 of D-1553 monotherapy	D-1553	Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy.

Primary Outcome Measures

Name	Time	Method
Subject incidence of Dose-limiting toxicities (DLT)	through out the DLT period, approximately 21 days	Subject incidence of Dose-limiting toxicities (DLT)
antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation	Through study completion, approximately 3 years	Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])
Number of subjects participants with adverse events	Through study completion, approximately 3 years	Number of subjects participants with adverse events

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of D-1553	approximately 6 months	Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation

Trial Locations

Locations (2)

Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,; 🇨🇳 Hangzhou, Zhejiang, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China