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

NCT07623369 | Recruiting Phase 1

• 2 other identifiers: HH160-101Himalaya
• Study Type: interventional
• Target: 299
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

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

Keywords

HH160; PD-1×CTLA-4×VEGF-A Antibody; Non-small Cell Lung Cancer; NSCLC; Hepatocellular Carcinoma; HCC; Colorectal Cancer; CRC; GEA; Head and Neck Squamous Cell Carcinoma; Renal Cell Carcinoma; RCC; Endometrial Cancer; Cervical Cancer; Small-cell Lung Cancer; Triple Negative Breast Cancer; TNBC; Urothelial Carcinoma; Gastroesophageal Adenocarcinoma; Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

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

  Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.

  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

  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.

  From first dose through the end of Cycle 1 (approximately 1 month)

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

  RP2D is defined as the dose level selected based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy

  From first dose through completion of Phase 1b dose optimization (up to 2 years)

• Phase 1b: Overall Response Rate (ORR)

  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.

  Up to 2 years

Secondary Outcomes (11)

• Phase 1a: Objective Response Rate (ORR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Phase 1a: Time to Response (TTR)

  Up to 2 years

Study Arms (3)

Phase 1a Part 1 : Dose Escalation

EXPERIMENTAL

Participants with advanced solid tumors will receive escalating doses of HH160

Drug: HH160

Phase 1a Part 2: Safety Expansion

EXPERIMENTAL

Participants with selected advanced or metastatic solid tumors will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability.

Drug: HH160

Phase 1b: Dose Expansion

EXPERIMENTAL

Additional participants with selected advanced or metastatic solid tumors will receive HH160 alone or in combination with chemotherapy at selected expansion dose levels and schedules identified during phase 1a.

Drug: HH160

Interventions

HH160 DRUG

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

Phase 1a Part 1 : Dose Escalation; Phase 1a Part 2: Safety Expansion; Phase 1b: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead
• BeOne Medicines: collaborator

Study Sites (3)

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Tasman Health Care

Southport, Queensland, 4215, Australia

RECRUITING

Shandong Tumour Hospital Dongyuan Unit

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular; Colorectal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Renal Cell; Endometrial Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma; Triple Negative Breast Neoplasms; Carcinoma, Transitional Cell; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Uterine Cervical Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Medical Officer

CONTACT

+86-010-80766688; zhouxin@hhhbio.com

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CN (1)