NCT07080242 Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
| NCT ID | NCT07080242 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SystImmune Inc. |
| Condition | Small Cell Lung Cancer Metastatic or Locally Advanced |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-04-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment * Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting. * No prior topoisomerase inhibitor-based ADC therapy is permitted. * In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgroup): participants will be eligible based on documented positive DLL3 expression. * At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 * Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy * No serious cardiac dysfunction and left ventricular ejection fraction ≥50% * Adequate organ function Exclusion Criteria: * Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration. * Participants who have received prior topoisomerase inhibitor-based ADC therapy * Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years * Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc. * Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable. * Participated in another clinical trial within 4 weeks prior to first dose of study treatment * Participants who are pregnant or breastfeeding, or planning to become pregnant during the study * Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial
Contact & Investigator
Rishi Jain
STUDY DIRECTOR
SystImmune Inc.
Frequently Asked Questions
Who can join the NCT07080242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer Metastatic or Locally Advanced. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07080242 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07080242 currently recruiting?
Yes, NCT07080242 is actively recruiting participants. Contact the research team at lien.huzzy@systimmune.com for enrollment information.
Where is the NCT07080242 trial being conducted?
This trial is being conducted at Huntsville, United States, Los Angeles, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT07080242 clinical trial?
NCT07080242 is sponsored by SystImmune Inc.. The principal investigator is Rishi Jain at SystImmune Inc.. The trial plans to enroll 120 participants.
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