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OpenTrials
Active, Not Recruiting

NCT Number: NCT05379946

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Hangzhou, Zhejiang, 310005, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, 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 (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
  • Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
  • Subject has measurable disease according to RECIST, v1.1

Exclusion criteria

Subject with unstable or progressive central nervous system (CNS) metastases.

  • Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
  • Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is > 480 msec based on triplicate measurements of electrocardiogram (ECG).
  • Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
  • Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
  • Subject is pregnant or lactating.

Treatment and study plan

D-1553

Drug

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

IN10018

Drug

IN10018 orally once daily at approximately the same time each day

Primary outcomes

  1. adverse events

    Time frame: Through study completion, approximately 3 years

    Number of subjects participants with adverse events

  2. Objective response rate (ORR) per RECIST v1.1

    Time frame: Through study completion, approximately 3 years

    Defined as the proportion of patients with complete response (CR) or partial response (PR).

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Collaborators

  • InxMed (Shanghai) Co., Ltd.

Registry information

Official study title

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
May 18, 2022
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.