Clinical trial · Interventional
A Trial of MBC-11 in Patients With CIBD
A Phase 1 Multicenter, Open-label, Dose-escalation Trial of MBC-11, an Etidronate-ara-C Conjugate in Patients With Malignant Tumors With Cancer-induced Bone Disease (CIBD)
NCT02673060CI-TRIAL-00021534completedPhase 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)
This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a cytostatic agent \[ara-C\] in patients with malignant tumors with CIBD. This is a first use in human.
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 |
|---|---|---|---|
| Bone Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBC-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dose escalation of MBC-11
- description
- MBC-11 was administered in 5 consecutively recruited cohort in dose 0.5 mg/kg, 1 mg/kg, 2.5 mg/kg, 5 mg/kg,10 mg/kg accordingly. The dose escalation is aimed at determining the maximum tolerated dose (MTD)
- interventionNames
- Drug: MBC-11
Primary outcomes (3)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- up to 20 weeks
- description
- evaluation of adverse events, physical examination, laboratory parameters
- measure
- Dose Limiting Toxicity [DLT]
- timeFrame
- up to 20 weeks
- description
- dose limiting toxicity is graded according to NCI CN CFT version 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignant tumor (breast cancer, prostate cancer etc) * Bone metastases, documented by radiographs, bone scan * No available standard chemotherapy or no indication for chemotherapy at the time of screening * Eastern Cooperative Oncology Group \[ECOG\] status 0-2 * Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3) * Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal \[ULN\], Alanine aminotransferase \[ALT\] ≤ 2.5 x ULN). * Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min \[measured or calculated by nomogram\]). Exclusion Criteria: * Systemic chemotherapy and/or investigational therapy within the previous 4 weeks * Fracture ≤ 6 month prior the inclusion in the study * Brain metastasis * Serum calcium levels \< 8.5 mg/dL (\< 2.2 mmol/L)
References
Publications (1)
- DERIVEDZinnen SP, Karpeisky A, Von Hoff DD, Plekhova L, Alexandrov A. First-in-Human Phase I Study of MBC-11, a Novel Bone-Targeted Cytarabine-Etidronate Conjugate in Patients with Cancer-Induced Bone Disease. Oncologist. 2019 Mar;24(3):303-e102. doi: 10.1634/theoncologist.2018-0707. Epub 2018 Nov 9. PMID 30413669