NCT06951243

A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer

An Open, Single-Arm, Single-Centre Efficacy and Safety Study of MHB088C for Injection in Patients With Advanced Extrapulmonary Neuroendocrine Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is an Open, Single-Arm, Single-Centre Efficacy and Safety Study of MHB088C for Injection in Patients with Advanced Extrapulmonary Neuroendocrine Cancer which cannot undergo surgical resection after failuer of standard treatment with platinum-contained or are unable to receive standard treatment with platinum-contained (including patients who are intolerant to standard treatment, deemed unsuitable for standard treatment by investigators, or refuse to receive standard treatment). Participants will receive MHB088C intravenously at a dose of 2.0 mg/kg every 2 weeks (Q2W) until disease progression, with drawal from the study, or death. During the study period, all participants will undergo tumor assessments every 2 treatment cycles (±7 days) in the first half-year after the first dose, and every 4 treatment cycles (±7 days) thereafter until disease progression, withdrawal from the study, or death. The schedule of tumor assessment related examinations is adjusted according to the administration time.After the end of treatment, all participants will receive a safety follow-up 30 days after the last dose,followed by survival follow-ups every 3 months until death, loss to follow-up, withdrawal of informed consent, or study termination by the institution.Biomarker analysis will be also performed on tumor samples collected from participants to explore their relationship with drug efficacy. The primary endpoint is ORR (RECIST v1.1).The secondary endpoints include DCR、DoR、PFS、OS (RECIST v1.1) and the safety of MHB088C.

Conditions

• Advanced Extrapulmonary Neuroendocrine Cancer

Interventions

Type	Name	Description
DRUG	MHB088C for Injection (B7-H3 ADC)	MHB088C for Injection, an antibody drug-conjugated molecule (ADC), is conjugated from a humanized monoclonal antibody targeting the B7-H3 molecule and a DNA topoisomerase I inhibitor (TOP1i) via protease-hydrolyzable linkers.The intervention will be administered intravenously at a dose of 2.0 mg/kg every 2 weeks (Q2W) until disease progression, withdrawal from the study, or death.

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-05-06
• Completion: 2028-05-06
• First posted: 2025-04-30
• Last updated: 2025-04-30