BL-M14D1 for Small Cell Lung Cancer

Recruiting at 2 trial locations

Overseen By Lien Huzzy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SystImmune Inc.

Must not be taking: Strong CYP inhibitors, Antitumor therapy

Disqualifiers: Severe heart disease, Active autoimmune, CNS metastases, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 year

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BL-M14D1 to determine its safety and effectiveness for people with certain advanced or metastatic lung and neuroendocrine cancers. The trial aims to understand how the body processes the drug and its efficacy against these cancers. Individuals who have tried at least one standard cancer treatment without success and have a type of neuroendocrine tumor, such as small cell lung cancer or neuroendocrine prostate cancer, might qualify. The treatment is administered through an IV once every three weeks. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial requires that you stop certain medications, including chemotherapy, biological therapy, and strong inhibitors or inducers of CYP enzymes, at least 2 to 4 weeks before starting the study. It's best to discuss your specific medications with the trial team to see if they need to be paused.

Is there any evidence suggesting that BL-M14D1 is likely to be safe for humans?

Earlier studies have investigated the safety of BL-M14D1, a treatment for small cell lung cancer and similar tumors. These studies remain in the early stages, aiming to determine how well patients tolerate the treatment, its mechanism in the body, and its initial effectiveness.

Since this trial is in its first phase, researchers focus primarily on understanding safety and side effects. Currently, limited information is available on side effects or patient responses. However, this type of trial is crucial to ensure the treatment's safety before testing it with more participants.

At this stage, small groups are commonly tested to closely monitor any negative effects. This approach helps ensure the treatment is safe enough for larger and more detailed studies in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

BL-M14D1 is unique because it offers a new approach to treating small cell lung cancer by being administered through an intravenous infusion every three weeks, which could potentially enhance patient convenience and adherence. Researchers are excited about BL-M14D1 because it might offer a different mechanism of action compared to the standard chemotherapy and immunotherapy treatments, potentially targeting cancer cells more effectively. Additionally, BL-M14D1 could provide an option for patients who have not responded well to existing treatments like cisplatin or etoposide, offering new hope in the fight against this aggressive cancer.

What evidence suggests that BL-M14D1 might be an effective treatment for small cell lung cancer?

Research is examining BL-M14D1, the investigational treatment in this trial, as a potential therapy for small cell lung cancer and similar tumors. Although limited information exists from human studies, early research focuses on understanding the drug's mechanism in the body. Scientists study how the drug is absorbed and its effects on cancer cells. Initial results suggest that BL-M14D1 might block certain pathways in cancer cells, potentially inhibiting their growth. As more data emerges, researchers will gain a clearer understanding of this treatment's effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Rishi Jain

Principal Investigator

SystImmune Inc.

Are You a Good Fit for This Trial?

Adults over 18, weighing more than 40 kg with certain advanced cancers (like small cell lung cancer and neuroendocrine tumors) who've tried at least one standard treatment without success or can't have standard treatments. They should be relatively active (good performance status), expect to live more than three months, and have a measurable tumor.

Inclusion Criteria

I can perform all my usual activities without assistance.

Signed the informed consent form voluntarily and agreed to follow the trial requirements

Has a life expectancy of ≥3 months

Exclusion Criteria

I haven't had cancer treatment in the last 4 weeks or 5 half-lives.

I have been treated with topoisomerase inhibitor-based ADC therapy before.

Participated in another clinical trial within 4 weeks prior to first dose of study treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

BL-M14D1 is administered on Day 1 by intravenous (IV) infusion every 3 weeks

1 year

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BL-M14D1

Trial Overview The trial is testing BL-M14D1's safety and effectiveness for patients with specific advanced cancers. It involves checking how the body processes the drug and observing its impact on the cancer. Participants must provide tissue samples from biopsies for analysis.

How Is the Trial Designed?

Group I: Experimental BL-M14D1 administered Day 1 per cycle Experimental Treatment 1 Intervention

BL-M14D1 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/NCT06505824

A Study of BL-M14D1 in Patients With Locally Advanced or ... This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, ...

2. clin.larvol.com clin.larvol.com/trial-detail/NCT06505824

A Study of BL-M14D1 in Patients With Locally Advanced or ... Outcome Measure, Measure Description, Time Frame. Phase Ia: Dose limiting toxicity (DLT), DLTs are assessed according to NCI-CTCAE v5.0 during the first ...

3. trial.medpath.com trial.medpath.com/clinical-trial/f846931d498e0b92/nct07080242-bl-m14d1-small-cell-lung-cancer-neuroendocrine-tumors

Evaluating BL-M14D1 in Subjects With Locally Advanced or ... The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced...

4. synapse.patsnap.com synapse.patsnap.com/drug/e8b55fc240a04faf9c84610ec72765c1

BL-M14D1 - Drug Targets, Indications, Patents Clinical Trials associated with BL-M14D1 ... Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors. 100 Clinical Results associated with BL-M14D1.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12437200/

State of the art in treatment of small cell lung cancer - PMC Irinotecan and gemcitabine have demonstrated similar efficacy and outcomes when combined with carboplatin instead of etoposide. ... small cell ...

6. trials.braintumor.org trials.braintumor.org/trials/NCT06505824

A Study of BL-M14D1 in Patients With Locally Advanced or ... This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, ...

7. adisinsight.springer.com adisinsight.springer.com/trials/700375132

A Phase I Clinical Study to Evaluate the Safety, Tolerability ... A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M14D1 in ...