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| ID | Type | Description | Link |
|---|---|---|---|
| Himalaya | Other Identifier | Huahui Health |
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| Name | Class |
|---|---|
| BeOne Medicines | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Part 1 : Dose Escalation | Experimental | Participants with advanced solid tumors will receive escalating doses of HH160 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH160 | Drug | Administered by intravenous infusion every 3 weeks (Q3W) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Disease Control Rate (DCR) |
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Key Inclusion Criteria
Key Exclusion Criteria
NOTE: Other eligibility criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 1-877-828-5568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
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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.
| Up to 2 years |
| 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. | Up to 2 years |
| 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. | Up to 2 years |
| Time to Response (TTR) | 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. | Up to 2 years |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D064726 | Triple Negative Breast Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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