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Clinical Trials in China / NCT06166836
Active, not recruiting Phase 1/2

a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

NCT06166836 · tracked via the Priya Life Science China tracker
Sponsor
InxMed (Shanghai) Co., Ltd.
Phase
Phase 1/2
Started
2022-10-12
Last updated
2026-07-02

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

D1553IN10018(Ifebemtinib)

D1553: D1553 orally taken,600mg twice a day

IN10018(Ifebemtinib): IN10018 orally taken once daily at approximately the same time each day

Study 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 metastatic solid tumor with KRAS G12C mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Men or women aged ≥ 18 years at the time of signing the informed consent form. 2. Subjects with pathologically confirmed locally advanced or metastatic solid tumors. 3. Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. 4. 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. 5. Has measurable lesions at baseline according to RECIST 1.1 criteria. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose. Exclusion Criteria: 1. Prior KRAS G12C inhibitors treatment. 2. Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis. 3. Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose. 4. Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose. 5. Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension. 6. Haven't recovered from toxicity due to prior antitumor therapy 7. Pregnant or lactating women. 8. Malignant neoplasms other than study disease within 5 years prior to enrollment.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang
First Affiliated Hospital of Bengbu Medical College Bengbu China
Hunan Cancer Hospital Changsha China
Fujian Cancer Hospital Fuzhou China
First Affiliated Hospital of Gannan Medical University Ganzhou China
General Hospital Of Eastern Theater Command Nanjing China
Renmin Hospital of Wuhan University Wuhan China
Xuzhou Central Hospital Xuzhou China
Henan Cancer Hospital Zhengzhou China
The first Affiliated Hospital of Zhengzhou University Zhengzhou China

More InxMed (Shanghai) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06166836 on ClinicalTrials.gov ↗ ← All trials in China