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Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

NCT05379946 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-04-08

No results posted yet for this study

Summary

This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation

Conditions

Interventions

DRUG

D-1553

D-1553 is a oral dosed novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation

DRUG

IN10018

IN10018 orally once daily at approximately the same time each day

Sponsors & Collaborators

  • InxMed (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • InventisBio Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhengbo Song · Zhejiang Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2025-07-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379946 on ClinicalTrials.gov