BL-M05D1 for Cancer

Recruiting at 16 trial locations

Overseen By Whitney Eakins

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SystImmune Inc.

Must not be taking: Antitumor therapy, Steroids

Disqualifiers: Severe heart disease, Autoimmune diseases, Hypertension, Lung diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new drug, BL-M05D1, for individuals with advanced or metastatic solid tumors. Administered every three weeks through an IV infusion, the trial evaluates the drug's efficacy and the body's response. It may suit those whose tumors have returned or progressed after previous treatments and who lack other treatment options. Interested participants should have a tumor type that potentially expresses a specific marker called CLDN18.2 and have previously undergone certain targeted cancer treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, contributing to understanding its effects in people.

Do I have to stop taking my current medications to join the trial?

The trial requires that you stop certain treatments like chemotherapy, biological therapy, and others at least 4 weeks before starting the study drug. However, the protocol does not specify if you need to stop all current medications, so it's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that BL-M05D1 is likely to be safe for humans?

Previous studies have tested the treatment BL-M05D1 in patients with advanced or spreading solid tumors. These studies primarily assessed the treatment's safety and patient tolerance, focusing mainly on safety due to their early stage.

Research shows that BL-M05D1 is a targeted treatment, aiming at specific cancer markers. This targeting can help reduce side effects by primarily affecting cancer cells. However, detailed information on side effects remains limited because the treatment is still in early testing. Generally, early trials like this aim to find a safe dose and check for any immediate negative reactions.

In summary, BL-M05D1 is still under safety testing. The early phase of trials involves close monitoring to assess patient tolerance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BL-M05D1 for cancer because it offers a new approach by being administered via intravenous infusion every three weeks, potentially allowing for a more consistent and controlled delivery of the medication. Unlike traditional chemotherapy, which can affect both cancerous and healthy cells, BL-M05D1 may target specific cancer cells more precisely, reducing the impact on healthy tissue and possibly leading to fewer side effects. This targeted mechanism of action could make it a promising option for improving patient outcomes and quality of life compared to current standards of care.

What evidence suggests that BL-M05D1 might be an effective treatment for cancer?

Research has shown that BL-M05D1, which participants in this trial will receive, may help treat advanced or spreading solid tumors. This treatment employs a method where antibodies deliver medicine directly to cancer cells, aiming to protect healthy cells. In animal studies, BL-M05D1 effectively stopped tumor growth. Although human studies provide limited information, these early results suggest it could be effective against certain types of cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Sarah Tannenbaum

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or metastatic solid tumors, specifically those affecting the biliary tract, stomach/esophagus, or pancreas. Participants should have a type of cancer that's progressed despite treatment or has no available therapy.

Inclusion Criteria

My heart functions well with an ejection fraction of 50% or higher.

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

I agree to give my latest tumor samples for testing.

Exclusion Criteria

I have an active hepatitis B infection.

I have severe lung disease.

I have a history of lung inflammation or scarring.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BL-M05D1 in a dose-escalation format to determine the maximum tolerated dose

21-day cycles

1 visit per cycle (in-person)

Dose Finding

Participants receive BL-M05D1 to identify optimal dosing for expansion

21-day cycles

1 visit per cycle (in-person)

Dose Expansion

Participants receive BL-M05D1 at the recommended dose to further evaluate safety and efficacy

21-day cycles

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• BL-M05D1

Trial Overview The study is testing BL-M05D1 to assess its safety and effectiveness in treating various solid tumors. It will also look at how the body processes the drug (pharmacokinetics).

How Is the Trial Designed?

Group I: Experimental BL-M05D1 administered Day 1 per cycle Experimental Treatment 1 Intervention

BL-M05D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks

Who Is Running the Clinical Trial?

SystImmune Inc.

Lead Sponsor

Trials

23

Recruited

1,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07021066

Study Details | NCT07021066 | Evaluate the Safety, ... The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/475659

A Study of BL-M05D1 in Patients With Locally Advanced or ... This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07021066?term=AREA%5BBasicSearch%5D(ST101)&rank=8

Study Details | NCT07021066 | Evaluate the Safety, ... The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid ...

4. systimmune.com systimmune.com/bl-m05d1

BL-M05D1 BL-M05D1 Antibody Drug Conjugates (ADC) molecules utilize specific antibodies to deliver therapeutic small molecules specifically to cancer cells.

5. discovery.researcher.life discovery.researcher.life/article/abstract-3140-blm05d1-a-novel-claudin-182targeting-adc-demonstrates-specific-potent-antitumor-efficacy-in-preclinical-evaluation/b44c0847152e369cbf6f694969aaef44

Abstract 3140: BL-M05D1, a novel claudin 18.2-targeting ADC ... The antitumor efficacy of BL-M05D1 was evaluated in xenograft tumor models. BL-M05D1 exhibited strong tumor inhibition capacity toward the human ...

6. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/3140/735447/Abstract-3140-BL-M05D1-a-novel-claudin-18-2

Abstract 3140: BL-M05D1, a novel claudin 18.2-targeting ADC ... The antitumor efficacy of BL-M05D1 was evaluated in xenograft tumor models. BL-M05D1 exhibited strong tumor inhibition capacity toward the human ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06349811

A Study of BL-M05D1 in Patients With Locally Advanced or ... This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, ...

8. adisinsight.springer.com adisinsight.springer.com/trials/700383473

A Phase 1 Open-Label Study to Evaluate the Safety ... The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or ...