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

• ClinicalTrials.gov Identifier: NCT05379946
• Recruitment Status: Not yet recruiting
• First Posted: May 18, 2022
• Last Update Posted: August 8, 2022
• Sponsor: InventisBio Co., Ltd
• Collaborator: InxMed (Shanghai) Co., Ltd.
• Information provided by (Responsible Party): InventisBio Co., Ltd

Tracking Information

• First Submitted Date: May 13, 2022
• First Posted Date: May 18, 2022
• Last Update Posted Date: August 8, 2022
• Estimated Study Start Date: September 30, 2022
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2022)

• adverse events [ Time Frame: Through study completion, approximately 3 years ]
  Number of subjects participants with adverse events
• 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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Drug: D-1553
  • Drug: IN10018
• 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.
  Interventions:

  • Drug: D-1553
  • Drug: IN10018

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 13, 2022): 92
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2024
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

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 (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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05379946
• Other Study ID Numbers: D1553-106
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: InventisBio Co., Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: InventisBio Co., Ltd
• Original Study Sponsor: Same as current
• Collaborators: InxMed (Shanghai) Co., Ltd.

Investigators

• Principal Investigator: Zhengbo Song; Zhejiang Cancer Hospital

• PRS Account: InventisBio Co., Ltd
• Verification Date: August 2022