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

Phase 1

Terminated

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

• Registration Number: NCT05492045
• Lead Sponsor: InventisBio Co., Ltd

Brief 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.

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 First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Study Start: 2022-09-13
• Primary Completion: 2024-06-14
• Study Completion: 2024-06-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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.

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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 1b Dose escalation of D-1553 combination therapies	D-1553	Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Phase 1b Dose escalation of D-1553 combination therapies	Other	Phase 1b will determine maximal tolerated dose and/or recommended phase 2 dose of D-1553 in combination with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Phase 2 of D-1553 combination therapies	D-1553	Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Phase 2 of D-1553 combination therapies	Other	Phase 2 will evaluate the efficacy and safety of D-1553 combined with immunotherapy or targeted therapy in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.

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)
Number of subjects participants with adverse events	Till study completion, approximately 3 years	Number of subjects participants with adverse events
Antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation	Till study completion, approximately 3 years	Overall Response Rate (ORR, Complete Response \[CR\] + Partial Response \[PR\])

Trial Locations

Locations (2)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

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