Clinical trial · Interventional
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
NCT01809912CI-TRIAL-00019951terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in patients with solid tumors for which no standard therapy is available.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant human apolipoprotein(a) Kringle V | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Greenstatin
- description
- 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 .
- interventionNames
- Drug: Recombinant human apolipoprotein(a) Kringle V
Primary outcomes (1)
- measure
- To investigate the safety and tolerability IV MG1102
- timeFrame
- A minimum of 9 weeks
- description
- Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.