Study to Evaluate D-1553 in Subjects With Lung Cancer

InventisBio

Status and phase

Completed

Phase 2

Phase 1

Conditions

NSCLC

Treatments

Drug: D-1553

Study type

Interventional

Funder types

Industry

Identifiers

NCT05383898

D1553-102

Details and patient eligibility

About

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

Enrollment

225 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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)

225 participants in 3 patient groups

Phase 1a Dose escalation of D-1553

Experimental group

Description:

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

Treatment:

Drug: D-1553

Phase 1b Dose expansion of D-1553

Experimental group

Description:

Phase 1b will evaluate more subjects with up to 2 different doses of D-1553 to confirm the recommended phase 2 dose.

Treatment:

Drug: D-1553

Phase 2 of D-1553 monotherapy

Experimental group

Description:

Phase 1b will evaluate more subjects at the recommended phase 2 dose of D-1553 to evaluate the efficacy.