Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors
Lead Sponsor:
InventisBio Co., Ltd
Collaborating Sponsors:
InxMed (Shanghai) Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05379946
Start Date
October 12 2022
End Date
December 1 2025
Last Update
April 8 2025
Active Locations (1)
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1
Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
Hangzhou, Zhejiang, China, 310005