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Monoclonal Antibodies

HCB101 for Cancer

Phase 1

Recruiting

Research Sponsored by FBD Biologics Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial investigates if a new drug is an effective treatment for cancer & what side effects it may cause.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors or non-Hodgkin lymphoma that's resistant to standard treatments. Participants must have measurable disease, be in fair health (ECOG 0-2), and able to provide tissue samples. They should not have had recent major surgery, untreated side effects from past treatments (except hair loss/anemia), blood transfusions within the last month, or certain other medical conditions.Check my eligibility

What is being tested?

The study tests HCB101, an IV drug targeting the SIRPα-CD47 pathway in patients with various advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma. The goal is to determine its effectiveness and safety profile.See study design

What are the potential side effects?

Potential side effects of HCB101 may include allergic reactions to its components, issues related to blood such as anemia if previously present, and possibly other common chemotherapy-related side effects like fatigue, nausea, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with MTD of HCB101

Number/incidence and percentage of subjects with adverse events, including ADA.

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC) of HCB101

Disease Control Rate (DCR)

Duration of Response (DoR)

+5 more

Other outcome measures

CD47 receptor occupancy on circulating red blood cells (RBCs)

Concentration of potential PD biomarkers in participants will be assess.

ctDNA detection

Trial Design

1Treatment groups

Experimental Treatment

Group I: HCB101Experimental Treatment1 Intervention

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, and 5.12 mg/kg sequentially.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

FBD Biologics LimitedLead Sponsor

Media Library

HCB101 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05892718 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: HCB101

Non-Hodgkin's Lymphoma Clinical Trial 2023: HCB101 Highlights & Side Effects. Trial Name: NCT05892718 — Phase 1

HCB101 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05892718 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available for individuals to participate in this investigation?

"Unfortunately, this clinical trial is not actively seeking participants. First posted on August 18th 2023 and last updated on the 17th of that same month, it appears to have reached its target sample size. However, there are currently over 2 thousand other medical studies with open recruitment slots available."

Answered by AI

What is the geographical scope of this clinical trial?

"As of now, the research is accepting participants in 6 medical centres located across Huntersville, Greenville and New Taipei City as well other cities. It may be advantageous to select a clinic within close proximity to reduce travel obligations if you are accepted into the trial."

Answered by AI

Has HCB101 been granted regulatory approval by the FDA?

"Given the lack of clinical evidence and data regarding its safety, HCB101 was given a score of 1 on our internal assessment scale."

Answered by AI

What is the core purpose of this experiment?

"FBD Biologics Limited, the study's sponsor, has identified that Number of Subjects with MTD of HCB101 as their primary outcome metric. This will be measured over 12 months intervals. Alongside this principal statistic, secondary data points such as Tmax (Time to maximum drug concentration in plasma), DOR (Duration of Response) and ORR (Overall Rate Response) will also be monitored for efficacy analyses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

2023. "A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892718.