Active — Not RecruitingPhase 1

A Study of A166 in Patients With Advanced Solid Malignant Tumors

China120 participantsStarted 2018-08-09

Plain-language summary

This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntarily sign informed consent form;
✓. Age ≥ 18 years old, no gender limit;
✓. Patients had a histologically confirmed incurable locally advanced or metastatic solid tumors;
✓. Determined HER2-positive disease (detected by ISH or NGS) or HER2-expressing disease by evaluation or detection. Definition of HER2 expression in this study: Immunohistochemistry \[IHC\] ≥ 1＋;
✓. Patients unable to benefit from the available standard treatment according to the judgment of the investigator;
✓. White blood cell count (WBC) ≥ 4.0×109/L or ≥ lower limit of normal value; Neutrophil count (NEUT) ≥ 1.5×109/L; Platelet count (PLT) ≥ 100×109/L; Hemoglobin concentration ≥ 9.0 g/dL;
✓. Total bilirubin (TBIL) ≤ 1.5×ULN. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN). For patients with liver metastases, ALT and AST ≤ 5 times ULN, and for patients with liver and/or bone metastases, alkaline phosphatase ≤ 5 times ULN;
✓. Creatinine clearance rate ≥ 50 ml/min;

Exclusion criteria

✕. Severe or uncontrollable heart disease requiring treatment, or grade 3 or 4 congestive heart failure according to the New York Society of Cardiology (NYHA), or unstable angina pectoris that cannot be controlled by drugs, or history of myocardial infarction within 6 months prior to enrollment, or severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia);
✕. History of ≥ Grade 3 allergic reaction to trastuzumab;
✕. Permanent with drawal of trastuzumab due to any previous toxicity;
✕. Patients with brain metastases who have symptoms or who have received the radiotherapy or surgery within 3 months before the first administration;
✕. Patients requiring oxygen therapy in daily activities;
✕. Grade 2 or higher peripheral neuropathy;
✕. Any chemotherapy, hormone therapy (except dexamethasone), radiotherapy, immunotherapy or biological therapy received within 4 weeks before the first administration;
✕. Prior-treatment with other clinical research drugs within 4 weeks before the first administration;

What they're measuring

Objective Response Rate (ORR)

Timeframe: up to 24 month

Trial details

NCT IDNCT05311397

SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Breast Cancer trials