Advanced MalignanciesPhase 1NCT07859228
A Phase 1 Study of HCB303 in Participants With Advanced Malignancies
A Phase 1 study testing HCB303 in people with Advanced Malignancies, run by FBD Biologics Limited.
Trial summary
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with Advanced Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- HCB303
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2027to 28 Feb 2030
- 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
- The participant is able to understand and willing to provide signed informed consent, including compliance with the requirements and restrictions described in the ICF and protocol.
- Male or female participant ≥18 years of age at the time of signing the ICF.
- Histologically or cytologically confirmed advanced solid tumor with relapsed, refractory, or progressive disease and no available standard therapy known to provide clinical benefit.
- At least 1 measurable lesion per RECIST v1.1, as assessed by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
- 6. Estimated life expectancy ≥12 weeks, in the judgment of the Investigator.
Who cannot join
- Tumor-Related Medical Conditions
- Other malignancies requiring treatment within 2 years before the first dose of HCB303, except for adequately treated locally curable malignancies, such as basal cell or squamous cell skin cancer, or other malignancies treated with no relapse within 2 years.
- Primary central nervous system (CNS) tumor, active or untreated CNS metastases, or carcinomatous meningitis. Participants with previously treated brain metastases may participate if clinically stable for at least 28 days, have no evidence of new or enlarging brain metastases, and do not require high-dose corticosteroids within 14 days before the first dose of HCB303. Participants receiving low-dose corticosteroids, defined as <20 mg prednisone or equivalent per day, may participate.
About this study
Official title: A Phase 1, Open-label, Multi-regional, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants With Advanced Malignancies
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with Advanced Malignancies
- Conditions
- Advanced Malignancies
- Being tested
- HCB303
- Keywords
- Advanced Malignancies, HCB303
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCB303Drug
Dose escalation from 0.03 mg/kg to 30 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| HCB303 | Active comparator | Not described Receives: Drug: HCB303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of HCB303; determine the MTD and the RDE.
Number/incidence, percentage, severity, and relationship of AEs, SAEs, TEAEs, and DLTs; MTD, if reached, and RDE of HCB303.
Measured: 28 days after 1st dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Feb 2027 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Model description
- Dose escacaltion.
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT07859228
- Sponsor's protocol ID
- HCB303-ONC-101
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-regional, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07859228
- Acronym / sponsor ID
- HCB303-ONC-101
- Conditions
- Advanced Malignancies
- Keywords
- Advanced Malignancies, HCB303
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- FBD Biologics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- HanchorBio Inc.
- Study start
- 28 Feb 2027 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 5 Oct 2026 (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.
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with Advanced Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escacaltion.
| Arm | Type | Receives |
|---|---|---|
| HCB303 | Active comparator | Drug: HCB303 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant is able to understand and willing to provide signed informed consent, including compliance with the requirements and restrictions described in the ICF and protocol.
- Male or female participant ≥18 years of age at the time of signing the ICF.
- Histologically or cytologically confirmed advanced solid tumor with relapsed, refractory, or progressive disease and no available standard therapy known to provide clinical benefit.
- At least 1 measurable lesion per RECIST v1.1, as assessed by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
Key exclusion criteria (3 listed)
- Tumor-Related Medical Conditions
- Other malignancies requiring treatment within 2 years before the first dose of HCB303, except for adequately treated locally curable malignancies, such as basal cell or squamous cell skin cancer, or other malignancies treated with no relapse within 2 years.
- Primary central nervous system (CNS) tumor, active or untreated CNS metastases, or carcinomatous meningitis. Participants with previously treated brain metastases may participate if clinically stable for at least 28 days, have no evidence of new or enlarging brain metastases, and do not require high-dose corticosteroids within 14 days before the first dose of HCB303. Participants receiving low-dose corticosteroids, defined as <20 mg prednisone or equivalent per day, may participate.
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 |
|---|---|---|
| HCB303Dose escalation from 0.03 mg/kg to 30 mg/kg. | Drug | HCB303 |
Primary outcome
Evaluate the safety and tolerability of HCB303; determine the MTD and the RDE.
Time frame: 28 days after 1st dose.
Number/incidence, percentage, severity, and relationship of AEs, SAEs, TEAEs, and DLTs; MTD, if reached, and RDE of HCB303.
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 5 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCB303 in people with Advanced Malignancies, run by FBD Biologics Limited.
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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of HCB303; determine the MTD and the RDE. (time frame: 28 days after 1st dose.). 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 5 Oct 2026.