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OpenTrials
Completed

NCT Number: NCT05383898

Study to Evaluate D-1553 in Subjects With Lung Cancer

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

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China

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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 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.

Treatment and study plan

D-1553

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.

Primary outcomes

  1. Subject incidence of Dose-limiting toxicities (DLT)

    Time frame: through out the DLT period, approximately 21 days

    Subject incidence of Dose-limiting toxicities (DLT)

  2. Number of subjects participants with adverse events

    Time frame: Through study completion, approximately 3 years

    Number of subjects participants with adverse events

  3. antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation

    Time frame: Through study completion, approximately 3 years

    Overall Response Rate (ORR, Complete Response [CR] + Partial Response [PR])

Secondary outcomes

  1. Plasma concentration of D-1553

    Time frame: approximately 6 months

    Plasma concentration of D-1553 as a single agent in subjects with advanced or metastatic NSCLC with KRas G12C mutation

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 20, 2022
Registry last updated
Oct 15, 2024

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.

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