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NCT Number: NCT07623369

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.

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Key information

Conditions

Solid Tumor Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Small-cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Triple Negative Breast Cancer Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Calvary Mater Newcastle, Waratah, New South Wales, Australia

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About this study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary antitumor activity of HH160 alone or in combination with antitumor agents in participants with advanced or solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC), gastroesophageal adenocarcinoma (GEA), head and neck squamous cell carcinoma, renal cell carcinoma (RCC), endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, urothelial carcinoma, and additional tumor types based on emerging clinical data.

The study will also identify the recommended phase 1 dose (RP2D) of HH160 monotherapy and/or in combination with other chemotherapy regimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • Adults aged 18 to 75 years with signed informed consent.
  • Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.
  • At least 1 measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.
  • Adequate organ function based on protocol-specified laboratory criteria.

Key Exclusion Criteria

  • Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  • History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.
  • Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  • Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis.

NOTE: Other eligibility criteria may apply.

Treatment and study plan

HH160

Drug

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

Primary outcomes

  1. Phase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160

    Time frame: 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.

  3. Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160

    Time frame: 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

  4. Phase 1b: Overall Response Rate (ORR)

    Time frame: 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.

Secondary outcomes

  1. Phase 1a: Objective Response Rate (ORR)

    Time frame: Up to 2 years

    Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as determined by investigator assessment using RECIST v1.1.

  2. Disease Control Rate (DCR)

    Time frame: Up to 2 years

    Defined as the percentage of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator assessment using RECIST v1.1.

  3. Duration of Response (DOR)

    Time frame: Up to 2 years

    Defined as the time from the date that a response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first as determined by investigator assessment using RECIST v1.1.

  4. Progression-free Survival (PFS)

    Time frame: Up to 2 years

    PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment using RECIST v1.1.

  5. Phase 1a: Time to Response (TTR)

    Time frame: Up to 2 years

    TTR is defined as the time from start of treatment to the first date that response criteria (CR or PR) were met, as determined by investigator assessment using RECIST v1.1.

  6. Maximum Observed Plasma Concentration (Cmax) of HH160

    Time frame: Up to 4 months

  7. Elimination Half Time (T1/2) of HH160

    Time frame: Up to 4 months

  8. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to 4 months

  9. Observed Clearance of HH160

    Time frame: Up to 4 months

  10. Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast)

    Time frame: Up to 4 months

  11. Phase 1b: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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 2 years

    Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs meeting protocol-defined adverse event of clinical interests (AECIs)..

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Officer

CONTACT

[email protected]

+86-010-80766688

Study Director

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

Huahui Health

Industry

Collaborators

  • BeOne Medicines

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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