Status:
RECRUITING
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors
Lead Sponsor:
InxMed (Shanghai) Co., Ltd.
Collaborating Sponsors:
InventisBio Co., Ltd
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metas...
Detailed Description
This study includes 2 phases: Phase Ib-Dose Escalation and Phase II-Dose Expansion. Phase Ib-Dose Escalation part will enroll at least 6 subjects to identify the safety and RP2D of D1553 in combinatio...
Eligibility Criteria
Inclusion
- Men or women aged ≥ 18 years at the time of signing the informed consent form.
- Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
- Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA.
- Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) Phase II Cohort A: subjects with locally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locally advanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locally advanced or metastatic solid tumors.
- Has measurable lesions at baseline according to RECIST 1.1 criteria.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose.
Exclusion
- Prior KRAS G12C inhibitors treatment.
- Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis.
- Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose.
- Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose.
- Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension.
- Haven't recovered from toxicity due to prior antitumor therapy
- Pregnant or lactating women.
- Malignant neoplasms other than study disease within 5 years prior to enrollment.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06166836
Start Date
October 12 2022
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (10)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
2
First Affiliated Hospital of Bengbu Medical College
Bengbu, China
3
Hunan Cancer Hospital
Changsha, China
4
Fujian Cancer Hospital
Fuzhou, China