Advanced Solid TumorPhase 1NCT05892718
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
A Phase 1 study testing HCB101 in people with Advanced Solid Tumor and Refractory Non-Hodgkin Lymphoma, run by FBD Biologics Limited at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Refractory Non-Hodgkin Lymphoma
- What is being tested?
- HCB101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 2 Oct 2023to 15 Nov 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and willing to sign the ICF.
- Male and female subjects of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy.
- For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
- For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
- Must have ECOG performance status of 0 to 2 at Screening.
- Able to provide tumor tissue samples.
- Have life expectancy of ≥12 weeks.
Who cannot join
- With known history of hypersensitivity to any components of HCB101.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB101.
- Clinically significant cardiovascular condition.
- 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.
- With known inherited or acquired bleeding disorder or bleeding diathesis. .
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- Have RBC transfusion within 4 weeks prior to Screening.
- With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.
- Any investigational or approved systemic cancer therapy.
- 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 ≤ 81 mg/QD.
- Have used herbal medication within 14 days prior to the first dose of HCB101.
- Have received any treatment targeting the CD47 or SIRPα pathway.
- Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101.
- Participation in another clinical study with an investigational product administered in the last 14 days prior to receiving the first dose of HCB101.
- An investigational device used within 28 days prior to the first dose of HCB101.
- Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
- Known to have a history of alcoholism or drug abuse.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Shannon Garcia, 214-648-4118
Tian Zhang, Dr.
- Recruiting
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, 29605
Jill Roemmich, 864-455-3600
Jeffery Edenfield, Dr.
- Recruiting
Carolina BioOncology
Huntersville, North Carolina, 28078
Ashley Wallace, 980-441-1021
John Powderly, Dr.
- Recruiting
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Christine Gerdes, 772-408-5159
Nicholas Iannotti, Dr.
Taiwan3 sites, 3 recruiting
- Recruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561
Yu-Yan Hong, 886-2-22490088 ext. 8767
Wei-Hong Cheng, Dr.
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chia-Hsuan Yang, 886-2-23123456 ext. 68057
Chia-Chi Lin, Dr.
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Pei-Ling Chiu, 886-2-28757270 ext 2999
Mu-Hsin Chang, Dr.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Ying Wang, +8618367124548, nancywangying@163.comm
Ying Wang
About this study
Official title: A Phase 1, Open-label, Multi-center, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HCB101 in Subjects With Advanced Solid Tumors or Relapsed and Refractory Non-Hodgkin Lymphoma
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.
Read the detailed description
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.
- Being tested
- HCB101
- Keywords
- Immunotherapy, CD47, SIRPα, Solid Tumor, Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCB101Drug
Also called SIRPα-Fc fusion protein
HCB101 administered via. intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HCB101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/incidence and percentage of subjects with adverse events, including ADA.
To evaluate the safety and tolerability of HCB101
Measured: 12 months
Number of subjects with MTD of HCB101
To evaluate the safety and tolerability of HCB101
Measured: 12 months
Secondary outcomes (8)
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Measured: 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)
Measured: 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)
Measured: 12 months
Progression-Free Survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start2 Oct 2023
- Primary completion30 May 2027 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FBD Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892718
- Sponsor's protocol ID
- HCB101-101
- Status last verified
- Feb 2026
- First submitted
- 9 May 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-center, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HCB101 in Subjects With Advanced Solid Tumors or Relapsed and Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05892718
- Acronym / sponsor ID
- HCB101-101
- Keywords
- Immunotherapy, CD47, SIRPα, Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- FBD Biologics LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCB101 | Experimental | Drug: HCB101HCB101 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and willing to sign the ICF.
- Male and female subjects of ≥18 years of age.
- Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy.
- For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
- For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
Key exclusion criteria (17 listed)
- With known history of hypersensitivity to any components of HCB101.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB101.
- Clinically significant cardiovascular condition.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCB101Also: SIRPα-Fc fusion proteinHCB101 administered via. intravenous (IV) infusion. | Drug | HCB101 |
Primary outcome
Number/incidence and percentage of subjects with adverse events, including ADA.
Time frame: 12 months
To evaluate the safety and tolerability of HCB101
Number of subjects with MTD of HCB101
Time frame: 12 months
To evaluate the safety and tolerability of HCB101
8 secondary outcomes
Overall Rate Response (ORR)
Time frame: 12 months
Duration of Response (DoR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Peak Plasma Concentration (Cmax) of HCB101
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB101
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB101
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB101
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCB101 in people with Advanced Solid Tumor and Refractory Non-Hodgkin Lymphoma, run by FBD Biologics Limited at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Taiwan, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FBD Clinical (+886-2-27921366, HCB101-101@hanchorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/incidence and percentage of subjects with adverse events, including ADA. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.