MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors (NCT06912152) | Clinical Trial Compass
RecruitingPhase 1
MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
China12 participantsStarted 2025-05-12
Plain-language summary
This is an open-label, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response.
This investigation comprehensively evaluates the pharmacodynamic and pharmacokinetic profile of MT027 cellular therapy through three primary objectives: (1) systematic monitoring of treatment-emergent adverse events and clinically significant laboratory parameter deviations; (2) assessment of antitumor activity with correlative biomarker analysis; and (3) characterization of cellular kinetics including biodistribution patterns, mechanistic pathways of therapeutic activity, and comprehensive immunogenicity assessment measuring both cellular/humoral immune responses against MT027 cells. The protocol further investigates potential host-versus-product immune reactions through longitudinal monitoring of donor-specific antibodies and cytokine release profiles, while employing advanced molecular tracking methodologies to elucidate cellular persistence and functional modulation within the tumor microenvironment.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in this study and provide a signed and dated written informed consent form before undergoing any study-specific procedures, sampling, or analyses;
✓. Aged 18-70 years (inclusive), regardless of gender;
✓. Diagnosed with primary malignancy confirmed by pathology and/or histology (with complete pathological report provided), including:Advanced solid tumors that have failed ≥2 lines of prior standard therapy;Advanced solid tumors (e.g., gastric cancer, colorectal cancer, platinum-resistant advanced ovarian cancer, fallopian tube cancer, etc.) with no standard treatment available, or for which accessible treatments have failed, or for which the investigator deems the patient intolerant to accessible treatments based on comprehensive risk-benefit assessments (intolerance defined as ≥Grade 3 adverse reactions post-treatment, or reactions below Grade 3 but persistent or recurrent, impacting continued treatment). All related adverse reactions must resolve to ≤Grade 1 or return to baseline before screening or the first dose.Primary malignant peritoneal tumors confirmed by pathology and/or histology, including primary peritoneal cancer, peritoneal mesothelioma, etc., with failed or intolerable standard therapy;Other solid tumors with peritoneal metastasis judged by the investigator to lack standard treatment options.
✓. Clear systemic treatment plan for primary and metastatic lesions, with no anticipated changes during the study;
✓. Confirmed peritoneal metastasis via biopsy, cytology, CT, or prior evidence;
What they're measuring
1
Incidence of Adverse events after MT027 cells infusion
. Enhanced CT shows intraperitoneal space-occupying lesions with ≥1 measurable lesion (per iRECIST criteria); or evaluable malignant peritoneal effusion via ultrasound (per WHO criteria);
✓. Willingness to provide recent FFPE tissue samples, pathological slides (8 consecutive unstained slides), or ascites tumor cells for B7-H3 expression testing, with confirmed B7-H3 positivity;
✓. No intraperitoneal drug injections (including hyperthermic intraperitoneal chemotherapy) within 1 month before signing the informed consent, except diagnostic paracentesis;