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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-06-14

Brief Summary

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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.

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Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b Dose escalation of D-1553 combination therapies

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.

Group Type EXPERIMENTAL

D-1553

Intervention Type 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.

Other

Intervention Type DRUG

Standard treatment of NSCLC.

Phase 2 of D-1553 combination therapies

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.

Group Type EXPERIMENTAL

D-1553

Intervention Type 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.

Other

Intervention Type DRUG

Standard treatment of NSCLC.

Interventions

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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.

Intervention Type DRUG

Other

Standard treatment of NSCLC.

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No