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.
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.
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.
Sequential
HH160
DrugAdministered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.
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.
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.
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
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.
Phase 1a: Objective Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as determined by investigator assessment using RECIST v1.1.
Disease Control Rate (DCR)
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.
Duration of Response (DOR)
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.
Progression-free Survival (PFS)
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.
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Huahui Health
Lead sponsor
BeOne Medicines
Collaborator
