NCT06951243

A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer

Not yet recruiting Phase 2 Last updated 30 April 2025

What this trial tests

Phase 2 trial testing MHB088C for Injection (B7-H3 ADC) in Advanced Extrapulmonary Neuroendocrine Cancer in 40 participants. Not yet recruiting.

Timeline

6 May 2025

Primary endpoint
6 May 2026

6 May 2028

Quick facts

Lead sponsor	Beijing GoBroad Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	6 May 2025
Primary completion	6 May 2026
Estimated completion	6 May 2028

Drugs / interventions tested

• MHB088C for Injection (B7-H3 ADC) — full drug profile →

Conditions studied

• Advanced Extrapulmonary Neuroendocrine Cancer — all drugs for Advanced Extrapulmonary Neuroendocrine Cancer →

Sponsor

Beijing GoBroad Hospital

Who can join

Adults 18 to 80, any sex, with Advanced Extrapulmonary Neuroendocrine Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. B7-H3 in Cancer Immunotherapy-Prospects and Challenges: A Review of the Literature.
   Mielcarska S, Kot A, Dawidowicz M, Kula A, et al · · 2025 · cited 5× · PMID 40801642 · DOI 10.3390/cells14151209