A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer (NCT06951243) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Trial of MHB088C in Advanced Extrapulmonary Neuroendocrine Cancer
40 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Voluntary Consent: Subjects voluntarily agree to participate in the study and sign the informed consent form.
✓. Age: 18 years ≤ age ≤ 80 years, regardless of gender.
✓. ECOG Performance Status: ECOG performance status score of 0 or 1.
✓. Life Expectancy\*\*: Expected survival time of at least 3 months.
✓. Contraception Requirements:
✓. Compliance: Ability to understand trial requirements and willingness/ability to comply with trial and follow-up procedures.
✓. Diagnosis: Histologically or cytologically confirmed unresectable or metastatic extrapulmonary neuroendocrine carcinoma.
✓. Prior Treatment:
Exclusion criteria
✕. History of multiple primary malignancies: Diagnosis of more than two primary malignancies within 5 years prior to signing the informed consent form, except for effectively treated non-melanoma skin cancer, carcinoma \*in situ\* of the cervix, or other malignancies deemed cured.
What they're measuring
1
Evaluate the Objective Response Rate (ORR) of MHB088C in Participants with Advanced Extrapulmonary Neuroendocrine Cancer after failuer of systematic treatment with platinum-contained (RECIST v1.1)
Timeframe: From the first dose until disease progression, withdrawal from the study, or death from any cause (whichever occurs first), assessed up to 24 months
✕. Recent investigational treatment: Participation in other non-marketed clinical trials or receipt of investigational drugs/therapies within 4 weeks prior to the first dose of the study drug.
✕. Central nervous system (CNS) involvement:
✕. Previously received B7-H3-targeted therapy.
✕. Adverse reactions from previous anti-tumor treatments have not recovered to CTCAE v5.0 grade ≤1 (except for toxicities deemed by the investigator to pose no safety risk, such as alopecia, hypothyroidism stabilized with hormone replacement therapy, etc.).
✕. Has underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.
✕. Has underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.