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Monoclonal Antibodies

BL-M07D1 administered Day 1 of a 21-day cycle for Ovarian Cancer

Phase 1

Recruiting

Research Sponsored by SystImmune Inc.

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 though study completion, an average of 24 months

Awards & highlights

Study Summary

"This trial aims to test the safety, side effects, and effectiveness of BL-M07D1 in patients with advanced tumors that have a specific protein called HER2."

Who is the study for?

This trial is for adults with advanced tumors that express the HER2 protein, including cancers of the biliary tract, ovaries, cervix, endometrium, and bladder. Specific eligibility details are not provided but typically include health status and prior treatments.Check my eligibility

What is being tested?

The study is testing BL-M07D1's safety and effectiveness in treating HER2-positive tumors. It's an open-label trial meaning everyone knows they're getting BL-M07D1; there's no placebo or comparison group.See study design

What are the potential side effects?

While specific side effects of BL-M07D1 aren't listed here, similar cancer drugs can cause reactions at the infusion site, fatigue, nausea, diarrhea, blood count changes and increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ though study completion, an average of 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~though study completion, an average of 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and though study completion, an average of 24 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

Summary of safety

To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1

Trial Design

1Treatment groups

Experimental Treatment

Group I: BL-M07D1 administered Day 1 of a 21-day cycleExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SystImmune Inc.Lead Sponsor

20 Previous Clinical Trials

1,092 Total Patients Enrolled

Clinical LeaderStudy DirectorSystImmune Inc.

3 Previous Clinical Trials

351 Total Patients Enrolled

Frequently Asked Questions

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

What are the risks associated with administering BL-M07D1 on the first day of a 21-day cycle for patients?

"Given the early stage of this trial, where BL-M07D1 is given on Day 1 of a 21-day cycle, our team rates its safety at Level 1. This aligns with it being a Phase 1 trial, reflecting limited available data supporting both safety and efficacy."

Answered by AI

Are individuals still able to enroll in this ongoing medical trial?

"Indeed, information on clinicaltrials.gov specifies that this study is currently enrolling participants. The trial was initially disclosed on February 9th, 2024 and last revised on March 1st, 2024. A total of 280 individuals are sought after at a single designated site."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Affirmative. Information on clinicaltrials.gov confirms that recruitment is ongoing for this clinical study, which was first shared on February 9th, 2024 and last revised on March 1st, 2024. The aim is to enroll a total of 280 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

2024. "Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06293898.

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