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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSystImmune Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BL-M14D1

    Drug

    BL-M14D1 will be administered on D1 every 3 weeks.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Experimental BL-M14D1 administered Day 1 per cycleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assess safety and tolerability of BL-M14D1

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

Time frame
18 months

Secondary outcomes

1

To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04)

PK Endpoints: Serum concentration of BL-M14D1, total anti-DLL3 antibody, and free payload ED-04 vs time will be utilized, serum PK parameters will include Cmax, Tmax, AUC0-8, AUClast and, if possible, Kel, t1/2, CL, Vz, Vss of BL-M14D1, total anti-DLL-3 antibody, and Ed-04. These PK parameters will be calculated both after the first dose and after multiple doses if applicable.

Time frame
18 months
2

To investigate the antitumor activity of BL-M14D1

* Tumor response evaluated using RECIST v1.1, ORR, DCR, DoR, TTR, and PFS * OS

Time frame
18 months

Other outcomes

Sponsors and contacts

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