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

InventisBio

Status and phase: Terminated; Phase 2; Phase 1

Conditions: NSCLC

Treatments: Drug: Other; Drug: D-1553

Study type: Interventional

Funder types: Industry

Identifiers

NCT05492045

D1553-105

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Phase 1b Dose escalation of D-1553 combination therapies

Experimental group

Description:

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.

Treatment:

Drug: D-1553

Drug: Other

Phase 2 of D-1553 combination therapies

Experimental group

Description:

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.

Treatment:

Drug: D-1553

Drug: Other