Clinical Trials /

Study to Evaluate D-1553 in Subjects With Solid Tumors

NCT04585035

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate D-1553 in Subjects With Solid Tumors
  • Official 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 With KRasG12C Mutation

Clinical Trial IDs

  • ORG STUDY ID: D1553-101
  • NCT ID: NCT04585035

Conditions

  • Solid Tumor, Adult
  • NSCLC
  • CRC

Interventions

DrugSynonymsArms
D-1553Dose combination of D-1553 with other therapies
OtherDose combination of D-1553 with other therapies

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation of D-1553 monotherapyExperimentalPhase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.
  • D-1553
Dose combination of D-1553 with other therapiesExperimentalPhase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D.
  • D-1553
  • Other
Phase 2 of D-1553 monotherapy and combination therapiesExperimentalThe Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose.
  • D-1553
  • Other

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence of Dose-limiting toxicities (DLT)
Time Frame:through out the DLT period, approximately 21 days
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:InventisBio Inc.

Last Updated

March 10, 2021