Trials / Active Not Recruiting
Active Not RecruitingNCT05311397
A Study of A166 in Patients With Advanced Solid Malignant Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of A166 in Patients With Unresectable, Locally Advanced or Metastatic HER2-expressing Solid Tumors (KL166-I-01-CTP)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The first stage will determine the recommended stage 2 dose (RS2D) in patients with unresectable, locally advanced or metastatic HER2-expressing solid tumors based on safety, tolerability, pharmacokinetic characteristics and antitumor activity. The second stage will assess the safety, tolerability, pharmacokinetic characteristics and antitumor activity in dose-expansion cohorts (RS2D:3.6 mg/kg, 4.8 mg/kg and 6.0 mg/kg dose groups).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | A166 | A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells. |
Timeline
- Start date
- 2018-08-09
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
- First posted
- 2022-04-05
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05311397. Inclusion in this directory is not an endorsement.