Clinical trial · Interventional
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.
NCT00430846CI-TRIAL-00016367completedPhase 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)
Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease, Hodgkin | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Large-Cell, Anaplastic | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-35 | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: SGN-35
Primary outcomes (1)
- measure
- Incidence of adverse events and laboratory abnormalities
- timeFrame
- 1 month after last dose
Secondary outcomes (3)
- measure
- PK profile
- timeFrame
- 2 months after last dose
- measure
- Immunogenicity (anti-SGN-35 antibodies)
- timeFrame
- 1 month after last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed CD30-positive hematologic malignancy. * Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant. * Patients must have measurable disease of at least 10mm as documented by radiographic technique. * Must be at least 18 years of age. Exclusion Criteria: * Patients with current diagnosis of pcALCL (systemic ALCL eligible). * Patients with history of allogeneic stem cell transplant. * Patients who have had previous treatment with any anti-CD30 antibody.
References
Publications (2)
- RESULTYounes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965. PMID 21047225
- DERIVEDSuri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28. PMID 32596842