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HH160

Phase 1

Solid Tumor | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Jun 3, 2026

Target and mechanism

Molecular targetPD-1, VEGF-A, CTLA-4
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

HH160 · 1 trial · 12 indications

Phase 1 1
NCT07623369A First-in-Human Study of HH160 in Patients With Advanced Solid TumorsSolid Tumor
NOT YET_RECRUITING56 Analytics
PHASE1NOT YET_RECRUITING
A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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.

Secondary Endpoints

Objective Response Rate (ORR)
Up to 2 years
Disease Control Rate (DCR)
Up to 2 years
Duration of Response (DOR)
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a Part 1 : Dose EscalationEXPERIMENTALParticipants with advanced solid tumors will receive escalating doses of HH160
Phase 1a Part 2: Safety ExpansionEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
HH160DRUGAdministered by intravenous infusion every 3 weeks (Q3W)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

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 Statu...

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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about HH160

What is HH160 used for in solid tumors?

HH160 is an investigational small molecule being studied for the treatment of advanced solid tumors, including 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, and gastroesophageal adenocarcinoma.

What does HH160 target?

HH160 targets PD-1, VEGF-A, and CTLA-4, which are proteins involved in immune regulation and tumor growth. By targeting these proteins, HH160 is designed to modulate immune responses and inhibit tumor-associated pathways in solid tumors.

Who is developing HH160?

HH160 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical research to evaluate the safety and efficacy of HH160 in patients with advanced solid tumors.

What phase is HH160 in?

HH160 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is currently being studied in a first-in-human trial to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is HH160 in?

HH160 is being evaluated in a Phase 1 clinical trial with the identifier NCT07623369, titled 'A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors.' This trial is not yet recruiting and plans to enroll approximately 56 participants aged 18 years and older.

Is HH160 the same as other PD-1 or CTLA-4 inhibitors?

HH160 is a distinct investigational small molecule that simultaneously targets PD-1, VEGF-A, and CTLA-4. While it shares molecular targets with some approved immunotherapies, HH160 is a unique compound developed by BeOne Medicines Ltd. and is not the same as any other drug.