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| Name | Class |
|---|---|
| HanchorBio Inc. | UNKNOWN |
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The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
This is a phase 1, open-label, multicenter, dose-escalation study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and identification of maximum tolerated dose (MTD) of HCB301 intravenous injection in adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
Eligible subjects must have failed standard therapies, been intolerable, or been considered medically inappropriate by the investigator. Subjects will be treated until unacceptable AEs, radiographic or clinical documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 0.3 mg/kg HCB301 | Experimental | 0.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 0.6 mg/kg HCB301 | Experimental | 0.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 1.2 mg/kg HCB301 | Experimental | 1.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 2.4 mg/kg HCB301 | Experimental | 2.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 4.8 mg/kg HCB301 | Experimental | 4.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 9.6 mg/kg HCB301 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCB301 | Drug | HCB301 administered via. intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number/incidence and percentage of subjects with adverse events, including ADA. | To evaluate the safety and tolerability of HCB301. | 12 months |
| Number of subjects with MTD and RDE of HCB301. | To determine the MTD and RDE. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Rate Response (ORR) | ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR). | 12 months |
| Duration of Response (DoR) | DoR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD). |
| Measure | Description | Time Frame |
|---|---|---|
| CD47 receptor occupancy on circulating red blood cells (RBCs) | CD47 receptor occupancy on circulating red blood cells (RBCs) will be measured as an indication of target engagement. | 12 months |
| Concentration of potential PD biomarkers in participants will be assess. |
Inclusion Criteria:
Able to understand and be willing to sign the ICF.
Male and female subjects of ≥18 years of age.
Histologically/cytologically confirmed, locally advanced solid tumor:
subjects confirmed advanced solid tumors who have relapsed or refractory and should have no options for standard or approved therapies known to potentially confer clinical benefit or classical Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of systemic therapy.
For subjects with advanced solid tumors - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
For subjects with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
Must have ECOG performance status of 0 to 1 at Screening.
Able to provide tumor tissue samples.
Have a life expectancy of ≥12 weeks.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FBD Clinical | Contact | +886-2-27921366 | HCB301-101@hanchorbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health-Upstate | Recruiting | Greenville | South Carolina | 29605 | United States | |
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| Experimental |
9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
| Experimental: 15.0 mg/kg HCB301 | Experimental | 15.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
|
|
| 12 months |
| Disease Control Rate (DCR) | DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD). | 12 months |
| Progression-Free Survival (PFS) | Defined as the duration from the start of treatment until tumor progression or death of any cause. | 12 months |
| Peak Plasma Concentration (Cmax) of HCB301 | Peak Plasma Concentration (Cmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. | 12 months |
| Area under the plasma concentration versus time curve (AUC) of HCB301 | Area under the plasma concentration versus time curve (AUC) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. | 12 months |
| Time to maximum drug concentration in plasma (Tmax) of HCB301 | Time to maximum drug concentration in plasma (Tmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. | 12 months |
| Terminal elimination half-life (t1/2) of HCB301 | Terminal elimination half-life (t1/2) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. | 12 months |
Changes in CD47 receptor occupancy on circulating CD3+ T cells and TGFβ1, 2, 3 will be assessed after HCB301 treatment. |
| 12 months |
| ctDNA detection | ctDNA detection in participants using next-generation sequencing (NGS ). | 12 months |
| The First Affiliated Hospital, Zhejiang University School of Medicine |
| Recruiting |
| Hangzhou |
| China |
|
| Zhejiang Provincial Cancer Hospital | Recruiting | Hangzhou | China |
|
| Xuzhou Central Hospital | Recruiting | Xuzhou | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | China |
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| Southern Medical University Zhujiang Hospital | Recruiting | Zhujiang | China |
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| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
|
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D003966 | Camurati-Engelmann Syndrome |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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