Clinical trial · Interventional
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, a Fully Human Monoclonal Antibody Directed Against Platelet-derived Growth Factor Receptor Alpha (PDGFRα), in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
NCT00816400CI-TRIAL-00033451MEDI-575completedPhase 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)
Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-575 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
- description
- Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
- interventionNames
- Drug: MEDI-575
- type
- EXPERIMENTAL
- label
- MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
- description
- MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
- interventionNames
- Drug: MEDI-575
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced solid tumor for which no curative or standard therapies exist * Karnofsky performance status of ≥ 60 * Life expectancy of \>12 weeks * Adequate hematologic and organ function * Negative serum pregnancy test (women only) * Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential Exclusion Criteria: * Prior chemotherapy or investigational treatment within 4 weeks of study drug administration * Prior biological or immunological treatment within 6 weeks of study drug administration * Concurrent therapy for of cancer * Major surgery within four weeks or minor surgery within two weeks of study drug administration * History of diabetes or current treatment for diabetes * New York Heart Association ≥ Grade 2 congestive heart failure * History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry * History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured) * Significant active infection * Known brain metastases * Pregnancy or lactation or plans to become pregnant while on study * Clinically significant abnormality on ECG
References
Publications (1)
- BACKGROUNDBecerra CR, Conkling P, Vogelzang N, Wu H, Hong S, Narwal R, Liang M, Tavakkoli F, Pandya N. A phase I dose-escalation study of MEDI-575, a PDGFRalpha monoclonal antibody, in adults with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Nov;74(5):917-25. doi: 10.1007/s00280-014-2567-9. Epub 2014 Aug 23. PMID 25149088