RecruitingPhase 1NCT06307925

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors

A Phase I Open-label, Multi-center, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors


Sponsor

HC Biopharma Inc.

Enrollment

122 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety, how the body processes (pharmacokinetics), and early signs of anti-cancer activity of a new experimental drug called HC010 in people with advanced solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have an advanced solid tumor confirmed by biopsy, and standard treatments have either failed or are not available - Your cancer has at least one measurable lesion on imaging - Your general health status is good (ECOG 0 or 1) - Your organ function (blood counts, liver, kidneys) is within acceptable ranges - Your expected survival is at least 3 months **You may NOT be eligible if...** - You are under 18 or over 75 - Your cancer does not have measurable disease - You have not failed at least one line of standard therapy - You have serious organ dysfunction or poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHC010

HC010 Q2W/28d intravenous infusion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06307925


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