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NCT07080242 · ClinicalTrials.gov registry record · Phase 1

Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

A Phase 1 study of Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer, sponsored by SystImmune.

Recruiting
Registry status
Phase 1
Development phase
120
Enrollment target
20
Study locations

NCT07080242: Recruiting Phase 1 study of Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer, sponsored by SystImmune.

NCT07080242 is a Phase 1 study of Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer that is actively recruiting participants, run by SystImmune. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07080242, a Phase 1 study of Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer, is actively recruiting participants, sponsored by SystImmune.

RECRUITING
Registry status
Phase 1
Development phase
120 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Primary Outcome

SAEs, AESIs, TEAEs, death, TEAEs leading to discontinuation, DLTs, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, ECG parameters (including the change-from-baseline ECG parameters), and ECHO/MUGA findings

Conditions Studied

Small Cell Lung Cancer Metastatic or Locally Advanced Neuroendocrine Cancer Metastatic or Locally Advanced Neuroendocrine Prostate Cancer Metastatic or Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma Metastatic or Locally Advanced Merkel Cell Carcinoma Locally Advanced or Metastatic Large Cell Neuroendocrine Carcinoma of the Lung Metastatic or Locally Advanced Extrapulmonary Neuroendocrine Carcinoma Poorly Differentiated and/or High Grade Neuroendocrine Neoplasms With Evidence of DLL3 Expression

Interventions

  • DRUG BL-M14D1

Study Locations (20)

Texas

  • NEXT Dallas - Dallas
  • START Dallas- Fort Worth - Dallas
  • MD Anderson Cancer Center - Houston
  • NEXT Houston - Houston
  • START- San Antonio - San Antonio

California

  • Valkyrie Clinical Trials - Los Angeles
  • UCLA - Los Angeles
  • UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center) - San Francisco

New Jersey

  • John Theurer Cancer Center-Hackensack - Hackensack
  • Rutgers Cancer Institute - New Brunswick

Colorado

  • University of Colorado - Anschutz Cancer Pavilion - Aurora

Connecticut

  • Yale Cancer Center - New Haven

Georgia

  • Emory Winship - Atlanta

Kentucky

  • University of Kentucky - Markey Cancer Center - Lexington

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-04-28
Est. Completion 2027-12-31
Phase Phase 1
SystImmune

6 total trials

What NCT07080242 shows while recruiting

NCT07080242 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).

The record links to 8 conditions, with Small Cell Lung Cancer Metastatic or Locally Advanced appearing as the primary indexed condition, and to 1 intervention - of which BL-M14D1 is the first listed.

NCT07080242 names 20 study sites across 13 states, led by Texas, California, New Jersey.

Frequently Asked Questions

What is clinical trial NCT07080242 about?

NCT07080242 is a clinical study titled "Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors". The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

What is the current status of trial NCT07080242?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2025-04-28. Estimated completion is 2027-12-31.

What conditions does trial NCT07080242 study?

This clinical trial studies the following conditions: Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer, Metastatic or Locally Advanced Neuroendocrine Prostate Cancer, Metastatic or Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma, Metastatic or Locally Advanced Merkel Cell Carcinoma.

What interventions are being tested in trial NCT07080242?

The interventions under investigation include: BL-M14D1 (DRUG).

Who is sponsoring clinical trial NCT07080242?

This trial is sponsored by SystImmune, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07080242 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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How this trial's enrollment target compares

Where NCT07080242's enrollment target sits among peer trials

120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07080242

Source: ClinicalTrials.gov NCT07080242, the US trial registry maintained by the National Library of Medicine. NCT07080242 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.