NCT07623369

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
26mo left

Started Jun 2026

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Aug 2028

First Submitted

Initial submission to the registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

May 29, 2026

Last Update Submit

May 29, 2026

Conditions

Solid TumorNon-small Cell Lung CancerHepatocellular CarcinomaColorectal CancerRenal Cell CarcinomaEndometrial CancerCervical CancerSmall-cell Lung CancerUrothelial CarcinomaHead and Neck Squamous Cell CarcinomaGastroesophageal AdenocarcinomaTriple Negative Breast Cancer

Keywords

HH160PD-1×CTLA-4×VEGF-A AntibodyNon-small Cell Lung CancerNSCLCHepatocellular CarcinomaHCCColorectal CancerCRCGEAHead and Neck Squamous Cell CarcinomaRenal Cell CarcinomaRCCEndometrial CancerCervical CancerSmall-cell Lung CancerTriple Negative Breast CancerTNBCUrothelial CarcinomaGastroesophageal AdenocarcinomaOvarian Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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)

Secondary Outcomes (10)

  • 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

  • Time to Response (TTR)

    Up to 2 years

  • +5 more secondary outcomes

Study Arms (2)

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 solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal carcinoma (CRC), and other tumor types, will receive HH160 at dose levels determined to be tolerable during dose escalation to further evaluate safety and tolerability.

Drug: HH160

Interventions

HH160DRUG

Administered by intravenous infusion every 3 weeks (Q3W)

Phase 1a Part 1 : Dose EscalationPhase 1a Part 2: Safety Expansion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, HepatocellularColorectal NeoplasmsSquamous Cell Carcinoma of Head and NeckCarcinoma, Renal CellEndometrial NeoplasmsUterine Cervical NeoplasmsSmall Cell Lung CarcinomaTriple Negative Breast NeoplasmsCarcinoma, Transitional CellOvarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, Squamous CellHead and Neck NeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleGenital DiseasesUterine Cervical DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Study Director

    BeOne Medicines

    STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568clinicaltrials@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 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share