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Clinical Trials in Australia / NCT07623369
Recruiting Phase 1

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

NCT07623369 · tracked via the Priya Life Science Australia tracker
Sponsor
Huahui Health
Phase
Phase 1
Started
2026-06-11
Last updated
2026-08-21

Condition(s) studied

Solid TumorNon-small Cell Lung CancerHepatocellular CarcinomaColorectal CancerHead and Neck Squamous Cell CarcinomaRenal Cell CarcinomaEndometrial CancerCervical CancerSmall-cell Lung CancerTriple Negative Breast CancerUrothelial CarcinomaGastroesophageal Adenocarcinoma

Investigational drug(s) / intervention(s)

HH160

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
    Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
  • 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)
    The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
  • Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160 — From first dose through completion of Phase 1b dose optimization (up to 2 years)
    RP2D is defined as the dose level selected based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy
  • Phase 1b: Overall Response Rate (ORR) — Up to 2 years
    Defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) assessed by the investigator.

Trial sites (3)

FacilityCityRegionStatus
Calvary Mater Newcastle Waratah New South Wales Recruiting
Tasman Health Care Southport Queensland Recruiting
Shandong Tumour Hospital Dongyuan Unit Jinan Shandong Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer Recruiting
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Active, not recruiting
A Study of LY3200882 in Participants With Solid Tumors Active, not recruiting
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07623369 on ClinicalTrials.gov ↗ ← All trials in Australia