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

NCT05379946 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D1553-106
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• adverse events

  Number of subjects participants with adverse events

  Through study completion, approximately 3 years

• Objective response rate (ORR) per RECIST v1.1

  Defined as the proportion of patients with complete response (CR) or partial response (PR).

  Through study completion, approximately 3 years

Study Arms (2)

Phase 1b Dose escalation of D-1553 plus IN10018

EXPERIMENTAL

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; Drug: IN10018

Phase 2 Doseexpansion of D-1553 plus IN10018

EXPERIMENTAL

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; Drug: IN10018

Interventions

D-1553 DRUG

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

Phase 1b Dose escalation of D-1553 plus IN10018; Phase 2 Doseexpansion of D-1553 plus IN10018

IN10018 DRUG

IN10018 orally once daily at approximately the same time each day

Phase 1b Dose escalation of D-1553 plus IN10018; Phase 2 Doseexpansion of D-1553 plus IN10018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead
• InxMed (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,

Hangzhou, Zhejiang, 310005, China

Location

Study Officials

• Zhengbo Song

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: October 12, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)