Advanced Solid TumorPhase 1NCT06487624
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors
A Phase 1 study testing HCB301 in people with Advanced Solid Tumor and Refractory Hodgkin Lymphoma, run by FBD Biologics Limited at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Refractory Hodgkin Lymphoma
- What is being tested?
- HCB301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 2 Apr 2025to 31 May 2027
- 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 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.
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- Must have ECOG performance status of 0 to 1 at Screening.
- Able to provide tumor tissue samples.
- Have a life expectancy of ≥12 weeks.
Who cannot join
- With known history of hypersensitivity to any components of HCB301.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- 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.
- 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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
- 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.
- Have used herbal medication within 14 days prior to the first dose of HCB301.
- Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
- Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
- An investigational device used within 28 days prior to the first dose of HCB301.
- 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
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Dr. Tong, +886-2-27921366, hcb301-101@hanchorbio.com
- Recruiting
Zhejiang Provincial Cancer Hospital
Hangzhou
Dr. Zhu, +886-2-27921366, hcb301-101@hanchorbio.com
- Recruiting
Xuzhou Central Hospital
Xuzhou
Dr. Sun, +886-2-27921366, hcb301-101@hanchorbio.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Dr. Liu, +886-2-27921366, hcb301-101@hanchorbio.com
- Recruiting
Southern Medical University Zhujiang Hospital
Zhujiang
Dr. Hu, +886-2-27921366, hcb301-101@hanchorbio.com
United States1 site, 1 recruiting
- Recruiting
Prisma Health-Upstate
Greenville, South Carolina, 29605
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Li-Tzong Chen, MD, +886-2-27921366, hcb301-101@hanchorbio.com
About this study
Official title: A Phase 1, Open-label, Multicenter, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HCB301 in Subjects With Advanced Solid Tumors or Relapsed and Refractory cHL
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.
Read the 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.
- Conditions
- Advanced Solid Tumor, Refractory Hodgkin Lymphoma
- Being tested
- HCB301
- Keywords
- Immunotherapy, CD47, PD-L1, TGF-beta, Tumor, Cancer
- Medical subject headings
- Hodgkin Disease, Camurati-Engelmann Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCB301Drug
Also called 2023-3979 Solid Tumors
HCB301 administered via. intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HCB301 |
| 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. Receives: Drug: HCB301 |
| 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. Receives: Drug: HCB301 |
| 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. Receives: Drug: HCB301 |
| 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. Receives: Drug: HCB301 |
| Experimental: 9.6 mg/kg HCB301 | Experimental | 9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. Receives: Drug: HCB301 |
| 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. Receives: Drug: HCB301 |
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 HCB301.
Measured: 12 months
Number of subjects with MTD and RDE of HCB301.
To determine the MTD and RDE.
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 HCB301
Peak Plasma Concentration (Cmax) of HCB301 following single and repeated IV doses of HCB301 at different dose levels.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted5 Jul 2024
- Study start2 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FBD Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HanchorBio Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487624
- Sponsor's protocol ID
- HCB301-101
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HCB301 in Subjects With Advanced Solid Tumors or Relapsed and Refractory cHL
- ClinicalTrials.gov ID
- NCT06487624
- Acronym / sponsor ID
- HCB301-101
- Conditions
- Advanced Solid Tumor, Refractory Hodgkin Lymphoma
- Keywords
- Immunotherapy, CD47, PD-L1, TGF-beta, Tumor, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FBD Biologics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- HanchorBio Inc.
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Jul 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Experimental: 0.3 mg/kg HCB301 | Experimental | Drug: HCB3010.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 0.6 mg/kg HCB301 | Experimental | Drug: HCB3010.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 1.2 mg/kg HCB301 | Experimental | Drug: HCB3011.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 2.4 mg/kg HCB301 | Experimental | Drug: HCB3012.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 4.8 mg/kg HCB301 | Experimental | Drug: HCB3014.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 9.6 mg/kg HCB301 | Experimental | Drug: HCB3019.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
| Experimental: 15.0 mg/kg HCB301 | Experimental | Drug: HCB30115.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- With known history of hypersensitivity to any components of HCB301.
- Known active or untreated CNS metastases and/or carcinomatous meningitis.
- 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.
- 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 |
|---|---|---|
| HCB301Also: 2023-3979 Solid TumorsHCB301 administered via. intravenous (IV) infusion. | Drug | Experimental: 0.3 mg/kg HCB301, Experimental: 0.6 mg/kg HCB301, Experimental: 1.2 mg/kg HCB301, Experimental: 15.0 mg/kg HCB301, Experimental: 2.4 mg/kg HCB301, Experimental: 4.8 mg/kg HCB301, Experimental: 9.6 mg/kg HCB301 |
Primary outcome
Number/incidence and percentage of subjects with adverse events, including ADA.
Time frame: 12 months
To evaluate the safety and tolerability of HCB301.
Number of subjects with MTD and RDE of HCB301.
Time frame: 12 months
To determine the MTD and RDE.
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 HCB301
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC) of HCB301
Time frame: 12 months
Time to maximum drug concentration in plasma (Tmax) of HCB301
Time frame: 12 months
Terminal elimination half-life (t1/2) of HCB301
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 13 Apr 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.
7 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 HCB301 in people with Advanced Solid Tumor and Refractory Hodgkin Lymphoma, run by FBD Biologics Limited at 7 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 9 inclusion and 16 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, United States, Taiwan. 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, HCB301-101@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 13 Apr 2026.