RecruitingPhase 1NCT07623369

A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors

An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors

Sponsor

Huahui Health

Enrollment

299 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer Colorectal, Cancer Cervical Cancer Endometrial Cancer Urothelial Carcinoma Hepatocellular Carcinoma Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Solid Tumor Renal Cell Carcinoma Small Cell Lung Cancer Gastroesophageal Adenocarcinoma

Summary

This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HH160 for people with cervical cancer, colorectal, cancer, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 75 Years.

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

DRUGHH160

Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.

Locations(3)

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Tasman Health Care

Southport, Queensland, Australia

Shandong Tumour Hospital Dongyuan Unit

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT07623369

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