Study to Evaluate D-1553 in Subjects With Solid Tumors

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    200
  • sponsor
    InventisBio Co., Ltd
Updated on 20 April 2022
measurable disease

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.

Details
Condition Solid Tumor, Adult, NSCLC, CRC
Treatment Other, D-1553
Clinical Study IdentifierNCT04585035
SponsorInventisBio Co., Ltd
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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 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
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