Clinical trial · Interventional
Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors for Which Bevacizumab is Indicated
An Open Label Phase 1B Dose-Escalation Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors
NCT01332721CI-TRIAL-00036023completedPhase 1Results postedClinicalTrials.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)
The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.
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 |
|---|---|---|---|
| Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRC105 and Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TRC105 and Bevacizumab
- description
- Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.
- interventionNames
- Drug: TRC105 and Bevacizumab
Primary outcomes (1)
- measure
- Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab
- timeFrame
- 1.5 years
- description
- Three patients will be initially enrolled and treated at each dose level. If none of these 3 patients experiences a dose-limiting toxicity (DLT) during the 28-day evaluation period, dose escalation will proceed following review of safety data with appropriate site staff including the principal investigators at all sites. If 1 of 3 patients experiences DLT, the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will have been exceeded if ≥ 33% of patients experience DLT in a given cohort. DLT will have occurred when a patient has 1 or more toxicity listed in the table below that is at least possibly related to the combination of bevacizumab and TRC105 during the first 28 days (cycle 1).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven advanced or metastatic solid cancer 2. Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker (e.g., CEA, PSA, CA125) 3. Age of 18 years or older 4. ECOG performance status of 0 or 1 5. Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade ≤ 1 or baseline (except alopecia) 6. Adequate organ function 7. Willing and able to consent for self to participate in study Exclusion Criteria: 1. Prior treatment with TRC105 2. Serious dose-limiting toxicity related to prior bevacizumab 3. Current treatment on another therapeutic clinical trial 4. Receipt of an investigational agent within 28 days of starting study treatment 5. Prior surgery (including open biopsy) within 28 days of starting the study treatment 6. Prior radiation therapy or systemic therapy within 21 days of starting the study treatment 7. Minor surgical procedures such as fine needle aspirations, Mediport placement or core biopsies within 7 days of study treatment 8. Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg) 9. Symptomatic pericardial or pleural effusions 10. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks 11. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease (except in the expansion cohort at the MTD where brain metastases or primary brain tumors are eligible) 12. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the past 6 months 13. Active bleeding or pathologic condition that carries a high risk of bleeding 14. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy 15. Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last 28 days 16. Known active viral or nonviral hepatitis 17. Centrally located non-small cell lung cancer (regardless of histologic sub-type), or non-small cell lung cancer of squamous histology. 18. History of hemorrhage or hemoptysis (\>½ teaspoon bright red blood) within 6 months of starting study treatment 19. Open wounds or unhealed fractures within 28 days of starting study treatment 20. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment 21. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness 22. Pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.