A Study of A166 in Patients With Advanced Solid Malignant Tumors

NCT05311397 | Active Not Recruiting Phase 1

• 1 other identifier: KL166-I-01-CTP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1

  up to 24 month

Secondary Outcomes (3)

• Duration of Response (DOR)

  up to 24 month

• Progression-free survival(PFS)

  up to 24 month

• Overall Survival (OS)

  up to 24 month

Study Arms (2)

The first stage（Dose-escalation）

EXPERIMENTAL

According to the initial dose, the highest dose and the modified Fibonacci method, the dose escalation of A166 for injection is designed as: 0.1 mg/kg, 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg (the highest dose is tentatively set at 4.8 mg/kg).

Drug: A166

The second stage（Dose-expansion）

EXPERIMENTAL

The administered dose of A166 for injection is RS2D obtained in the first stage .

Drug: A166

Interventions

A166 DRUG

A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.

The first stage（Dose-escalation）; The second stage（Dose-expansion）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients had an Eastern Cooperative Oncology Group (ECOG)performance status of 0 or 1, the expected survival time is ≥ 3 months;
• During the study period and within 7 months after the final administration of A166, patients with fertility (regardless of male and female) must receive effective medical contraceptive measures;
• The patients must recover from all acute toxicities of the previous treatment (relieved to grade 1 or baseline), except for hair loss and vitiligo;

You may not qualify if:

• 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;
• Patients who have undergone major surgery within 4 weeks before the first administration;
• Active hepatitis B (hepatitis B surface antigen positive and HBV-DNA higher than the upper limit of reference value) or hepatitis C (positive hepatitis C virus antibody and HCV-RNA higher than the upper limit of reference value); current or past alcoholics ; Liver cirrhosis;
• Known active human immunodeficiency virus (HIV);
• Systemic diseases that cannot be controlled, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, glaucoma, etc according to investigator's judgment;
• Current pregnancy or lactation;
• QTc interval\> 470 ms according to the baseline measurement:;
• Left ventricular ejection fraction (LVEF) \<45% according to the echocardiogram (ECHO) or multi-gate circuit controlled acquisition (MUGA) ;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This 2-part, open-label, PhaseⅠstudy will administer A166 by IV infusion once every 3 weeks. Sequential dose-escalation cohorts are planned using a 3+3 design. An expansion study will be conducted based on the RS2D with comprehensive analysis of safety, tolerability, and pharmacokinetic data in the first phase

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 5, 2022
• Study Start: August 9, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)