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A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer

NCT06951243 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing GoBroad Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2026-05-06
Completion
2028-05-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951243 on ClinicalTrials.gov