RecruitingPhase 1Phase 2NCT06840821

Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors

A Phase I/II, Multicenter, Open-label, Single-arm, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 Sequential Therapy in Adult Subjects With Advanced Solid Tumors (Including Gastroenteropancreatic Neuroendocrine Neoplasms, Small Cell Lung Cancer or Triple Negative Breast Cancer)

Sponsor

Mainline Biosciences (Shanghai) Co., Ltd

Enrollment

156 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

This is a multicenter, open-label, single-arm, dose-escalation and dose-expansion Phase I/II study to evaluate the safety, tolerability and preliminary anti-tumor activity of MB0151 in adult subjects (at least 18 years old) with advanced solid tumors. This study includes two phases: dose escalation and dose expansion. In this study, the protocol of accelerated titration combined with i3+3 is used for dose escalation,administered intravenously every 2 weeks. Enrolled subjects will be sequentially assigned to the planned dose cohorts according to this protocol to receive MB0151 treatment and will be monitored for the occurrence of DLT. The RP2D and/or OBD will be determined by considering the PK profile, safety and efficacy data in the dose-escalation stage (including backfill cohorts).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug in people with advanced cancers that have stopped responding to standard treatments. The cancers being studied include small cell lung cancer (SCLC), certain types of gastrointestinal neuroendocrine tumors (GEP-NETs), and triple-negative breast cancer (TNBC). **You may be eligible if...** - You are 18 years old or older - You have small cell lung cancer, a gastrointestinal neuroendocrine tumor, or triple-negative breast cancer confirmed by a lab test - Your cancer has progressed after receiving standard treatment or you couldn't tolerate it - Your general health (ECOG) and organ function are within acceptable range **You may NOT be eligible if...** - You have active, untreated brain metastases - You have serious autoimmune or inflammatory conditions - You have had certain recent treatments that would conflict - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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