Clinical trial · Interventional
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
Phase I Study of ALT-801 in Patients With Progressive Metastatic Malignancies
NCT00496860CI-TRIAL-00011440completedPhase 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)
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801 in previously treated patients with progressive metastatic malignancies. ALT-801, a recombinant fusion protein with a interleukin-2 (IL-2) component, has a targeting mechanism that recognizes tumor cells with a specific tumor marker.
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 |
|---|---|---|---|
| Progressive Metastatic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALT-801 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies
- timeFrame
- 18 months
- description
- Number of serious adverse events per cohort
- measure
- The Maximum-tolerated Dose (MTD) of ALT-801
- timeFrame
- 18 months
- description
- Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
Secondary outcomes (3)
- measure
- Clinical Antitumor Response to ALT-801
- timeFrame
- 24 months
- description
- Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic malignancies * Histologically or cytologically confirmed * Evaluable * Surgically and medically incurable * Not responding to standard therapy or no other standard therapy exists * Human leukocyte antigen (HLA)-A2.1/p53 positive PRIOR/CONCURRENT THERAPY: * No prior Proleukin therapy within one year * No concurrent radiotherapy, chemotherapy, or other immunotherapy * More than 4 weeks since prior major radiotherapy * More than 4 weeks since prior cytotoxic therapy * More than 6 weeks since prior nitrosoureas therapy * More than 8 weeks since prior monoclonal antibody therapy PATIENT CHARACTERISTICS: Life expectancy * \> 3 months Performance status * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Bone marrow reserve * Absolute neutrophil count (AGC/ANC) ≥ 1,500/microliters (uL) * Platelets ≥100,000/uL * Hemoglobin ≥ 10g/dL Renal function * Serum creatinine ≤ 1.5 X Upper limit of normal (ULN) Hepatic function * Total bilirubin ≤ 1.5 X ULN * Aspartate Aminotransferase (AST) ≤ 2.5 X ULN * Alkaline phosphatase ≤ 2.5 X ULN * Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 X ULN * Activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN Cardiovascular * May be safely tapered off anti-hypertensives if currently on anti-hypertensives * New York Heart Association classification I or II * No congestive heart failure \<6 months * No unstable angina pectoris \<6 months * No myocardial infarction \<6 months * No history of ventricular arrhythmias * Normal cardiac stress test required if any of the following is present: * Over age 50 * History of abnormal EKG * Symptoms of cardiac ischemia or arrhythmia Pulmonary * Normal pulmonary function test (FEV1 ≥ 75% of predicted value) if any of the following is present: * Prolonged history of cigarette smoking * Symptoms of respiratory dysfunction Other * No known autoimmune disease * No known HIV positive * No psychiatric illness/social situations that would limit study compliance * No history or evidence of central nervous system (CNS) disease * No active systemic infection requiring parental antibiotic therapy * No systemic steroid therapy required * No prior organ allograft * Not receiving other investigational agents * Not receiving chronic medication for asthma * Not pregnant or nursing * Fertile patients must use effective contraception
References
Publications (1)
- DERIVEDFishman MN, Thompson JA, Pennock GK, Gonzalez R, Diez LM, Daud AI, Weber JS, Huang BY, Tang S, Rhode PR, Wong HC. Phase I trial of ALT-801, an interleukin-2/T-cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies. Clin Cancer Res. 2011 Dec 15;17(24):7765-75. doi: 10.1158/1078-0432.CCR-11-1817. Epub 2011 Oct 12. PMID 21994418