Safety Study of MG1102 in Patients With Solid Tumors
A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is an open-label, Dose Escalation Study, multicenter phase I study to evaluate the safety and tolerability, determine the pharmacokinetics, and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor.
Each subject will receive on dose of MG1102 followed by a 6-day rest period. If the initial dose is tolerated, subject will continue with the 21 days of MG1102 administration (5 days on treatment, 2 days off treatment for 3 weeks.) Subjects that have a tumor response as stable disease, may continue therapy on a compassionate use.
Study Duration : for a minimum of 8 weeks
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Seoul, Corée, République de, 120-752
- Yonsei Cancer Center, Yonsei University Severance Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years of age or older
- Solid tumors refractory to conventional therapy or the subject does not tolerate the conventional therapy
- Evaluable disease or at least one measurable tumor mass by a radiographic technique
- Life expectancy ≥3 months
- Suitable for intravenous administration of study medication
- Signed written informed consent
- Adequate bone marrow, renal, and liver function
- Coagulation profile with aPTT and INR, each ≤ 1.5 x ULN
- No evidence of active Hepatitis B or Hepatitis C infection
- Proteinuria <100 mg
- ECOG performance status ≤2
- Female subjects must agree to use contraceptive measures
- Negative serum ß-hCG
- Ability and willingness to comply with the study protocol
Exclusion Criteria:
- Pregnant or lactating women
- Therapy with systemic anticoagulant or antithrombotic agentswithin 7 days prior to first dose
- Hemoptysis within 3 months prior to first dose
- Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks prior to first dose
- Surgery or visceral biopsy within 28 days prior to first dose
- Minor surgical procedure performed within 7 days prior to first dose
- Prior exposure to MG1102
- Known history of HIV
- With active bacterial infections and/or receiving systemic antibiotics
- Current or past diagnosis of leukemia
- Known CNS metastases or clinical evidence of CNS
- Non-healing wound within past 2 weeks
- Bleeding diathesis or bleeding within 14 days prior to enrollment
- Clinically significant thrombosis
- Non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer disease
- History of idiopathic or hereditary angioedema
- History of sickle cell or any hemolytic anemia
- Require hemoglobin, WBC, or platelet transfusion support or use of hematopoietic growth factors within 2 weeks prior to entry
- Uncontrolled hypertension
- History of clinically significant renal disease
- History of significant medical illness of cardiac or CNS disease within the past 6 months
- Treatment with an investigational agent within the longest time frame of either 5 half-lives or 30 days of initiating study drug
- Medical or psychiatric illness
- Recreational substance use or psychiatric illness
- Known hypersensitivity to MG1102 or components of the formulation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Greenstatin
Cohort 1 : 6 mg/m2 Cohort 2 : 12 mg/m2 Cohort 3 : 24 mg/m2 Cohort 4 : 48 mg/m2 Cohort 5 : 96 mg/m2 Cohort 6 : 192 mg/m2 28 Day Course Subjects will receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) by IV administration on Day 0. If no DLTs are observed during the 6 days following the initial infusion, the same dose will be administered once daily for 5 consecutive days followed by a 2-day rest period three times (over 21 days), completing the course on Day 27. Additional 21 Day Courses In the absence of a DLT, and in the case of stable disease or better, a subject may continue to receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) on a compassionate use basis at the same dose and regimen . |
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To investigate the safety and tolerability IV MG1102
Délai: A minimum of 9 weeks
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Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles
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A minimum of 9 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102
Délai: for 25 days
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for 25 days
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standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102
Délai: A minimum of 10 weeks
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A minimum of 10 weeks
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Determination of response assessed by RECIST v1.1 and Choi criteria to obtain preliminary information regarding the efficacy of MG1102
Délai: A minimum of 11 weeks
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A minimum of 11 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: hyunchul chung, dr, Yonsei Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MG1102_001
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