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

NCT05492045 | Terminated Phase 1 FDA Drug

• 1 other identifier: D1553-105
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (3)

• Subject incidence of Dose-limiting toxicities (DLT)

  Subject incidence of Dose-limiting toxicities (DLT)

  Through out the DLT period, approximately 21 days

• Number of subjects participants with adverse events

  Number of subjects participants with adverse events

  Till study completion, approximately 3 years

• 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

Study Arms (2)

Phase 1b Dose escalation of D-1553 combination therapies

EXPERIMENTAL

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.

Drug: D-1553; Drug: Other

Phase 2 of D-1553 combination therapies

EXPERIMENTAL

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.

Drug: D-1553; Drug: Other

Interventions

D-1553 DRUG

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.

Phase 1b Dose escalation of D-1553 combination therapies; Phase 2 of D-1553 combination therapies

Other DRUG

Standard treatment of NSCLC.

Phase 1b Dose escalation of D-1553 combination therapies; Phase 2 of D-1553 combination therapies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310005, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: September 13, 2022
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)