Advanced Solid Tumor, Refractory Hodgkin Lymphoma
Conditions
Keywords
Immunotherapy, CD47, PD-L1, TGF-beta, Tumor, Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGHCB301
HCB301 administered via. intravenous (IV) infusion.
Sponsors
FBD Biologics Limited
HanchorBio Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand and be willing to sign the ICF. 2. Male and female subjects of ≥18 years of age. 3. 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. 4. 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. 5. For subjects with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response. 6. Must have ECOG performance status of 0 to 1 at Screening. 7. Able to provide tumor tissue samples. 8. Have a life expectancy of ≥12 weeks.
Exclusion criteria
1. With known history of hypersensitivity to any components of HCB301. 2. Known active or untreated CNS metastases and/or carcinomatous meningitis. 3. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301. 4. Clinically significant cardiovascular condition. 5. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia. 6. With known inherited or acquired bleeding disorder or bleeding diathesis. . 7. Have RBC transfusion within 4 weeks prior to Screening. 8. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months. 9. Any investigational or approved systemic cancer therapy administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug. 10. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on case by case basis. There will be no restriction for daily aspirin ≤ 100 mg/QD. 11. Have used herbal medication within 14 days prior to the first dose of HCB301. 12. Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway. 13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301. 14. An investigational device used within 28 days prior to the first dose of HCB301. 15. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis. 16. Known to have a history of alcoholism or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number/incidence and percentage of subjects with adverse events, including ADA. | 12 months | To evaluate the safety and tolerability of HCB301. |
| Number of subjects with MTD and RDE of HCB301. | 12 months | To determine the MTD and RDE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rate Response (ORR) | 12 months | ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR). |
| Duration of Response (DoR) | 12 months | 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). |
| Disease Control Rate (DCR) | 12 months | DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD). |
| Progression-Free Survival (PFS) | 12 months | Defined as the duration from the start of treatment until tumor progression or death of any cause. |
| Peak Plasma Concentration (Cmax) of HCB301 | 12 months | Peak Plasma Concentration (Cmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. |
| Area under the plasma concentration versus time curve (AUC) of HCB301 | 12 months | Area under the plasma concentration versus time curve (AUC) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. |
| Time to maximum drug concentration in plasma (Tmax) of HCB301 | 12 months | Time to maximum drug concentration in plasma (Tmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. |
| Terminal elimination half-life (t1/2) of HCB301 | 12 months | Terminal elimination half-life (t1/2) of HCB301 following single and repeated IV doses of HCB301 at different dose levels. |
Countries
China, Taiwan, United States
Contacts
CONTACTFBD Clinical
Outcome results
None listed