Phase
Condition
Neoplasms
Neuroblastoma
Treatment
D1553
IN10018(Ifebemtinib)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 (onlyfor phase1b) containing cancer cells or DNA.
Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locallyadvanced or metastatic solid tumors who have progressed on or failed in standardtherapy, and no standard treatment is available. 2) Phase II Cohort A: subjects withlocally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locallyadvanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locallyadvanced 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 tothe first dose.
Exclusion
Exclusion Criteria:
Prior KRAS G12C inhibitors treatment.
Have known symptoms of spinal cord compression, instable or symptomatic centralnervous system (CNS) metastases, and/or carcinomatous meningitis.
Have a history of stroke or other serious cerebrovascular diseases within 12 monthsprior to the first dose.
Have had interstitial lung disease or any active infection requiring systemictreatment 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.
Study Design
Study Description
Connect with a study center
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310005
ChinaActive - Recruiting
First Affiliated Hospital of Bengbu Medical College
Bengbu,
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha,
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou,
ChinaActive - Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou,
ChinaActive - Recruiting
General Hospital Of Eastern Theater Command
Nanjing,
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan,
ChinaActive - Recruiting
Xuzhou Central Hospital
Xuzhou,
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou,
ChinaActive - Recruiting
The first Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaActive - Recruiting
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