Phase 1 Lymphoma Trial, Recruiting NCT06487624 Sponsor: FBD Biologics Limited Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT06487624
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older, of any sex
  • People who are able to understand and willing to sign a consent form
  • People with a confirmed advanced solid tumour that has come back or stopped responding to treatment, and for whom no standard or approved treatment options remain
  • People with classical Hodgkin lymphoma (a type of blood cancer) that has come back or stopped responding to at least 2 previous rounds of treatment
  • People with an advanced solid tumour who have at least one tumour that can be measured on scans, according to standard research measurement guidelines
  • People with classical Hodgkin lymphoma whose cancer can be measured or assessed for response to treatment
  • People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities) at the screening stage
  • People who are able to provide a tumour tissue sample
  • People with a life expectancy of at least 12 weeks

Who may not be able to join:

  • People with a known allergy or sensitivity to any ingredient in the study drug HCB301
  • People with active or untreated cancer spread to the brain or spinal fluid
  • People who have had major surgery or intensive radiotherapy within the past 28 days, palliative (symptom-relieving) radiotherapy within the past 14 days, or a radioactive drug treatment within the past 56 days
  • People with a significant heart or blood vessel condition
  • People who still have side effects from previous cancer treatments that have not returned to a mild or baseline level (with the exception of hair loss and anaemia)
  • People with a known inherited or acquired bleeding disorder
  • People who have had a red blood cell transfusion within 4 weeks before the screening visit
  • People diagnosed with a condition causing the body to destroy its own red blood cells (haemolytic anaemia or Evans Syndrome) in the past 3 months
  • People who have received any other cancer treatment — either as part of another trial or as an approved therapy — within 21 days or within 5 half-lives of that treatment (whichever is shorter) before the start of this trial
  • People currently using warfarin or similar blood-thinning medications (use of some other blood thinners may be considered on a case-by-case basis; low-dose aspirin of 100mg or less per day is permitted)
  • People who have used herbal medicines within 14 days before the first dose of the study drug
  • People who have previously received treatments targeting specific immune pathways known as SIRPα-CD47, PD-L1, or TGF-β (confirm with trial site)
  • People who have had another cancer requiring active treatment within the past 2 years
  • People who have used an investigational medical device within 28 days before the first dose of the study drug
  • People who test positive for hepatitis B, active hepatitis C, HIV, or who have active or latent tuberculosis
  • People with a known history of alcohol or drug misuse

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +886-2-27921366

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
FBD Biologics Limited
Registry
ClinicalTrials.gov
Start date
2 April 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Number/incidence and percentage of subjects with adverse events, including ADA.; Number of subjects with MTD and RDE of HCB301.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov