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)
Recommended phase II dose (RP2D) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation — Through study completion, approximately 3 years Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation.
Objective Response Rate (ORR) of D1553 in combination with IN10018 in solid tumors with KRAS G12C mutation — Through study completion, approximately 3 years Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Trial sites (10)
Facility
City
Region
Status
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
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.
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