ClinicalTrials.gov

History of Changes for Study: NCT05379946
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors
Latest version (submitted August 5, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 13, 2022 None (earliest Version on record)
2 August 5, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT05379946
Submitted Date:  May 13, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: D1553-106
Brief Title: Study to Evaluate D-1553 in Combination With IN10018 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 Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Not yet recruiting
Study Start: June 30, 2022
Primary Completion: June 30, 2024 [Anticipated]
Study Completion: December 30, 2024 [Anticipated]
First Submitted: May 13, 2022
First Submitted that
Met QC Criteria:
May 13, 2022
First Posted: May 18, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
May 13, 2022
Last Update Posted: May 18, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: InventisBio Co., Ltd
Responsible Party: Sponsor
Collaborators: InxMed (Shanghai) Co., Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 92 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Phase 1b Dose escalation of D-1553 plus IN10018
Phase 1b will evaluate up sequential cohorts with different doses of IN10018 together with D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation.
Drug: D-1553
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
Drug: IN10018
IN10018 orally once daily at approximately the same time each day
Experimental: Phase 2 Doseexpansion of D-1553 plus IN10018
Phase 2 will include more subjects to further evaluate the safety and efficacy of D-1553 in combination with IN10018 in patients with solid tumors with KRasG12C mutation.
Drug: D-1553
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
Drug: IN10018
IN10018 orally once daily at approximately the same time each day
Open or close this module Outcome Measures
Primary Outcome Measures:
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).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 (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.
Open or close this module Contacts/Locations
Central Contact Person: Debo Nie
Telephone: (86)21-50663661
Email: debo.nie@inventisbio.com
Study Officials: Zhengbo Song
Principal Investigator
Zhejiang Cancer Hospital
Locations: China, Zhejiang
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China, 310005
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services