Clinical trial · Interventional
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
NCT00399113CI-TRIAL-00005210completedPhase 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)
The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 188Re-PTI-6D2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
- measure
- To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
- measure
- To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma; * measurable disease; * at least 18 years of age; * Karnofsky status at least 50%; * life expectancy \> 3 months; * at least 4 weeks since prior therapy; * adequate organ and marrow function defined by screening laboratory tests; * negative screening human anti-murine antibodies; * females of child-bearing potential must be practicing an acceptable method of birth control and have a negative urine pregnancy test; * written informed consent obtained Exclusion Criteria: * Chemotherapy or radiation therapy within 4 weeks or poor recovery from therapy \> 4 weeks ago; * investigational drug within 30 days; * brain metastasis (all patients must have contrast-enhanced MRI within 2 weeks of treatment to rule out); * ocular inflammatory disease or ocular neoplasm (all patients must have fundoscopic and slit lamp examination within 2 weeks of treatment to rule out exclusionary ocular pathology); * prior parenteral exposure to murine proteins; * positive hep B surface Ag, hep C antibody, or HIV test at screening; * uncontrolled intercurrent illness; * pregnant/breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.