Clinical trial · Interventional
A Study of MNRP1685A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors
NCT00954642CI-TRIAL-00027607completedPhase 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 is a Phase Ib, open-label, dose-escalation study of MNRP1685A given by intravenous (IV) infusion as therapy for locally advanced or metastatic solid tumors.
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 Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| MNRP1685A | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: bevacizumab
- Drug: MNRP1685A
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: bevacizumab
- Drug: MNRP1685A
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Incidence and nature of dose-limiting toxicities (DLTs)
- timeFrame
- Through study completion or early study discontinuation
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adequate hematologic and end organ function * Evaluable disease or measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) * Agreement to use an effective form of contraception for the duration of the study Inclusion Criteria Unique to Arm A: * Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen Inclusion Criteria Unique to Arm B: * Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy; a maximum of two prior chemotherapy regimens is allowed Exclusion Criteria: * Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter, prior to initiation of study treatment with the following exceptions: hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer; herbal therapy \> 1 week prior to Day 1; hormone-replacement therapy or oral contraceptives; palliative radiotherapy for bone metastases \> 2 weeks prior to Day 1 * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava * Leptomeningeal disease as a manifestation of the current malignancy * Active infection requiring IV antibiotics * Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of ≤ 10 mg/day prednisone * Bisphosphonate therapy for symptomatic hypercalcemia * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis * Known human immunodeficiency virus (HIV) infection * Known primary CNS malignancy, or untreated or active CNS metastases * Pregnancy, lactation or breast feeding * Inadequately controlled hypertension * History of hypertensive crisis or hypertensive encephalopathy * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * New York Heart Association (NYHA) Class II or greater CHF * History of stroke or transient ischemic attack (TIA) within 6 months prior to Day 1 * Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 * History of hemoptysis within 1 month prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy in the absence of stable therapeutic anticoagulation * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to Day 1 * Clinical signs or symptoms of gastrointestinal obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding because of an active gastrointestinal condition * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture * Intrathoracic lung carcinoma of squamous cell histology * Grade ≥ 2 sensory neuropathy * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * Known hypersensitivity to recombinant human antibodies Exclusion Criterion Unique to Arm B: * Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
References
Publications (0)
Data not yet available
No reference posted for this study.