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Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05379946
Recruitment Status : Not yet recruiting
First Posted : May 18, 2022
Last Update Posted : August 8, 2022
Sponsor:
Collaborator:
InxMed (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
InventisBio Co., Ltd

Study Description
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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

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: D-1553 Drug: IN10018 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 30, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2024
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05379946


Contacts
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Contact: Debo Nie (86)21-50663661 debo.nie@inventisbio.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China, 310005
Sponsors and Collaborators
InventisBio Co., Ltd
InxMed (Shanghai) Co., Ltd.
Investigators
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Principal Investigator: Zhengbo Song Zhejiang Cancer Hospital
More Information
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Responsible Party: InventisBio Co., Ltd
ClinicalTrials.gov Identifier: NCT05379946    
Other Study ID Numbers: D1553-106
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms