Cervical Cancer, Colorectal Cancer, Endometrial Cancer, Gastroesophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Small-cell Lung Cancer, Solid Tumor, Triple Negative Breast Cancer, Urothelial Carcinoma
Conditions
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
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.
Detailed description
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.
Interventions
DRUGHH160
Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.
Sponsors
Huahui Health
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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 Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks. 5. Adequate organ function based on protocol-specified laboratory criteria. Key
Exclusion criteria
1. Active leptomeningeal disease or uncontrolled/untreated brain metastases. 2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components. 3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers. 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. 5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis. NOTE: Other eligibility criteria may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: 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. |
| Phase 1a: 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. |
| Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160 | 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 |
| Phase 1b: Overall Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: Objective Response Rate (ORR) | 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. |
| Disease Control Rate (DCR) | 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. |
| Duration of Response (DOR) | 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. |
| Progression-free Survival (PFS) | 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. |
| Phase 1a: Time to Response (TTR) | 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. |
| Maximum Observed Plasma Concentration (Cmax) of HH160 | Up to 4 months | — |
| Elimination Half Time (T1/2) of HH160 | Up to 4 months | — |
| Time to Maximum Observed Plasma Concentration (Tmax) | Up to 4 months | — |
| Observed Clearance of HH160 | Up to 4 months | — |
| Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) | Up to 4 months | — |
| Phase 1b: 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 2 years | Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs meeting protocol-defined adverse event of clinical interests (AECIs).. |
Countries
Australia, China
Contacts
CONTACTMedical Officer
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed