Recruiting

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

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.

ClinicalTrials.gov IDNCT07623369

PhasePHASE1

Enrollment299

SponsorHuahui Health

Age18 Years – 75 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Drug: HH160 — Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.

Primary outcomes

Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160 (From first dose through the end of Cycle 1 (approximately 1 month))
Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160 (From first dose through completion of Phase 1b dose optimization (up to 2 years))
Phase 1b: Overall Response Rate (ORR) (Up to 2 years)

Eligibility information

Key Inclusion Criteria 1. Adults aged 18 to 75 years with signed informed consent. 2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements. 3. At least 1 measurable lesion per RECIST v1.1. 4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks. 5. Adequate organ function based on protocol-specified laboratory criteria. Key Exclusion Criteria 1. Active leptomeningeal disease or uncontrolled/untreated brain metastases. 2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components. 3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers. 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis. NOTE: Other eligibility criteria may apply.

Study locations

Calvary Mater Newcastle, Waratah, New South Wales 2298 Australia
Tasman Health Care, Southport, Queensland 4215 Australia
Shandong Tumour Hospital Dongyuan Unit, Jinan, Shandong China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.