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Clinical Trials in the USA / NCT04585035
Active, not recruiting Phase 1/2

Study to Evaluate D-1553 in Subjects With Solid Tumors

NCT04585035 · tracked via the Priya Life Science USA tracker
Sponsor
InventisBio Co., Ltd
Phase
Phase 1/2
Started
2020-10-02
Last updated
2025-03-18

Condition(s) studied

Solid Tumor, AdultNSCLCCRC

Investigational drug(s) / intervention(s)

D-1553D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other

D-1553: 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.

D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other: Standard treatment of solid tumor, NSCLC or CRC

Study summary

This is a phase 1/2, open label study of D-1553 single agent and combination 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 solid tumor with KRasG12C mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 bio-specimens 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 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 has any history or evidence of substance abuse or medical, psychological or social conditions that may, in the opinion of the investigator, interfere with participation in the study or evaluation of the study results. * Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications. * Subject has unresolved toxicities from prior anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE, v5.0, Grade ≤ 1 (Grade ≤ 2 for peripheral neuropathy). * Subject had major surgery within 4 weeks prior to study intervention administration or last dose of palliative radiation therapy within 2 weeks prior to study intervention administration. * Subject is pregnant or lactating.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Research Site Fresno California
Research Site Orange California
Research Site San Francisco California
Research Site Louisville Kentucky
Research Site Detroit Michigan
Research Site New York New York
Research Site Portland Oregon
Research Site Blacktown New South Wales
Research Site East Albury New South Wales
Research Site Kogarah New South Wales
Research Site Waratah New South Wales
Research Site Woodville South South Australia
Research Site Fitzroy Victoria
Research Site Frankston Victoria
Research Site Malvern Victoria
Research Site Nedlands Western Australia
Research Site Seogu Busan
Research Site Seongnam-si Gyeonggi-do
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Tainan Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taoyuan City Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04585035 on ClinicalTrials.gov ↗ ← All trials in the USA