Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to find out whether IV injection of HCB101 is an effective treatment for different types of advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
This is an open-label, multi-center, dose-escalation, Phase 1 study. This study is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and identification of maximum tolerated dose (MTD) of HCB101 intravenous injection in adults with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCB101 | Experimental | HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, 5.12 mg/kg, 8.00 mg/kg, 12.00 mg/kg, 18.00 mg/kg, 24.00 mg/kg, 30.00 mg/kg and 36 mg/kg sequentially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCB101 | Drug | HCB101 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 HCB101 | 12 months |
| Number of subjects with MTD of HCB101 | To evaluate the safety and tolerability of HCB101 | 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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FBD Clinical | Contact | +886-2-27921366 | HCB101-101@hanchorbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology Associates of the Treasure Coast | Recruiting | Port Saint Lucie | Florida | 34952 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 HCB101 | Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. | 12 months |
| Area under the plasma concentration versus time curve (AUC) of HCB101 | Area under the plasma concentration versus time curve (AUC) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. | 12 months |
| Time to maximum drug concentration in plasma (Tmax) of HCB101 | Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. | 12 months |
| Terminal elimination half-life (t1/2) of HCB101 | Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels. | 12 months |
Changes in macrophage function related cytokines will be assess after HCB101 treatment. |
| 12 months |
| ctDNA detection | ctDNA detection in participants using next-generation sequencing (NGS ). | 12 months |
| Carolina BioOncology | Recruiting | Huntersville | North Carolina | 28078 | United States |
|
| Greenville Hospital System University Medical Center (ITOR) | Recruiting | Greenville | South Carolina | 29605 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare | Recruiting | New Taipei City | 23561 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided