RecruitingPhase 1NCT07381829

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer

Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population


Sponsor

HC Biopharma Inc.

Enrollment

328 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase Ib study tests the safety and early effectiveness of HC010 — a new experimental drug — combined with standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) or small cell lung cancer that has not responded to prior treatments. **You may be eligible if...** - You have confirmed advanced or metastatic solid tumors (dose-finding phase) or specifically NSCLC or extensive small cell lung cancer (expansion phase) that cannot be surgically removed - Your NSCLC either has no targeted gene mutations, has EGFR mutations that progressed on targeted therapy, or is first-line treatment eligible - You have at least one measurable tumor lesion - Your overall health status is good (ECOG 0–1) - Your expected survival is at least 3 months - Your organ function is within acceptable ranges **You may NOT be eligible if...** - Your only measurable lesion is in the brain - You have had serious side effects from prior immunotherapy - You are pregnant or breastfeeding - You have uncontrolled infections, severe heart conditions, or other serious illnesses 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 once every 3 weeks (Q3W) by intravenous drip

DRUGPaclitaxel (Chemotherapy)

the combination chemotherapy regimens are all commonly used in clinical practice

DRUGPemetrexed

the combination chemotherapy regimens are all commonly used in clinical practice

DRUGEtoposide

the combination chemotherapy regimens are all commonly used in clinical practice

DRUGCarboplatin/Cisplatin

the combination chemotherapy regimens are all commonly used in clinical practice

DRUGDocetaxel

the combination chemotherapy regimens are all commonly used in clinical practice


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07381829


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