NCT04914351

HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours

A Phase Ⅰ, Multi-center, Open-label, Single-arm, Dose Escalation, First-in-human Clinical Study of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Shanghai HyaMab Biotech Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, first-in-human trial to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors.

Detailed description

This is a Phase I, first-in-human trial to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors (head and neck, liver, colorectal and lung cancers, etc). Six dosing cohorts are planned with the dose of 0.03, 0.3, 1, 2, 4 and 10 mg/kg. The first two dose levels (0.03 and 0.3 mg/kg) will each enroll one patient using an accelerated escalation design that will convert to a 3+3 design upon the occurrence of one treatment-related Grade 2 toxicity occurring in the safety evaluation window following the first dose of treatment. After the initial two cohorts are completed, the study will use a standard 3+3 dose escalation design. The number of enrolled patients is estimated to be up to 32. The dose limiting toxicity evaluation period will be the first 28 days (Cycle 1) and subsequent cycles will be 4 weeks in duration. Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation. HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond.

Conditions

• Locally Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	HY-0102	Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle

Timeline

• Start date: 2022-05-03
• Primary completion: 2023-11-27
• Completion: 2023-12-30
• First posted: 2021-06-04
• Last updated: 2024-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study