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BH3120 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Hanmi Pharmaceutical Company Limited

Eligibility Criteria Checklist

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

Must have

Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study until treatment discontinuation (up to 2-3 years)

Awards & highlights

Study Summary

This trial is testing a new drug called BH3120 in patients with advanced or metastatic solid tumors. The purpose of the trial is to determine the safety, tolerability, appropriate dosage, how the

Who is the study for?

This trial is for individuals with advanced or metastatic solid tumors. Participants must meet specific health criteria, which are not detailed here.Check my eligibility

What is being tested?

The study tests BH3120 to find the safest and most effective dose for treating solid tumors. It has two parts: finding the maximum tolerated dose (MTD) and then testing that dose in more patients to see how well it works.See study design

What are the potential side effects?

Since this is a first-in-human study of BH3120, side effects are being determined. Common side effects in trials like this may include nausea, fatigue, allergic reactions, and other drug-specific effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a measurable tumor that has not been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.

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I am at least 18 years old or the legal adult age in my country.

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My cancer shows PD-L1 positive expression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study until treatment discontinuation (up to 2-3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study until treatment discontinuation (up to 2-3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study until treatment discontinuation (up to 2-3 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence and nature of DLTs

Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.

Secondary outcome measures

Disease Control Rate (DCR)

Duration of response (DOR)

Frequency of anti-drug antibodies (ADA)

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BH3120Experimental Treatment1 Intervention

BH3120 will be administered intravenously (IV) once every 3 weeks. (Q3W)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hanmi Pharmaceutical Company LimitedLead Sponsor

190 Previous Clinical Trials

60,914 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants currently being recruited for this ongoing medical study?

"Indeed, as stated on clinicaltrials.gov, this study is currently in the recruitment phase. The trial was initially posted for public access on December 28th, 2023 and has been recently updated on January 29th, 2024."

Answered by AI

At how many different venues can this clinical trial be accessed?

"In addition to Severance Hospital in Seoul and Asan Medical Center in Hackensack, there are several other locations where patients can enroll for this clinical trial. These include the John Theurer Cancer Center at Hackensack University Medical Center in Cincinnati, as well as nine other sites."

Answered by AI

Has the BH3120 received approval from the FDA?

"The safety of BH3120 is currently rated 1 on a scale from 1 to 3 by our team at Power. This rating reflects the limited data available regarding its safety and efficacy, as it is still in Phase 1 of clinical trials."

Answered by AI

What is the primary goal of conducting this clinical trial?

"The primary outcome of this study, as reported by the trial sponsor Hanmi Pharmaceutical Company Limited, will be to determine the incidence and nature of dose-limiting toxicities (DLTs) throughout the entire study period until 90 days after the last treatment. Secondary outcomes include evaluating the objective response rate (ORR), defined as the proportion of participants with a confirmed complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, disease control rate (DCR) will be measured as the proportion of participants with confirmed complete response, partial response, or stable disease according to RECIST v"

Answered by AI

What is the current number of participants being enrolled in this clinical investigation?

"To fulfill the requirements of this trial, a total of 191 eligible participants must be enrolled. Patients from different locations including Severance Hospital in Seoul, New jersey, and Asan Medical Center in Hackensack, Ohio can participate in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors

2023. "Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234397.

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