CompletedPhase 1Results posted

Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies

Phase I Study of ALT-801 in Patients With Progressive Metastatic Malignancies

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Oncology

Eligibility highlights

Primary endpoints

•Serious AEs (any)•Maximum-tolerated Dose (MTD) of ALT-801

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00496860

Org study IDCA-ALT-801-01-06

Timeline

Milestones

Study first posted2007-07-04estimated

Results first posted2013-07-15estimated

Last update posted2013-07-22estimated

Study start2007-05 (month precision)

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Assets

Investigational agents

Pemvidutide

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies

Time frame:18 months

Serious AEs (any)

event count, event

Posted result

Group	Number · Events	95% CI
ALT-801 0.015 mg/kg/Dose	0	-
ALT-801 0.040 mg/kg/Dose	2	-
ALT-801 0.080 mg/kg/Dose	4	-

Primary/protocol endpoint

The Maximum-tolerated Dose (MTD) of ALT-801

Time frame:18 months

descriptive

Posted result

Group	Number · events	95% CI
ALT-801 0.015 mg/kg/Dose	0	-
ALT-801 0.040 mg/kg/Dose	1	-
ALT-801 0.080 mg/kg/Dose	2	-

Secondary/protocol endpoint

ALT-801 Induced Cell-mediated Immune Responses

Time frame:24 months

descriptive

Posted result

Group	Mean · IFNg spots per million PMBCs	95% CI
ALT-801 0.015 mg/kg/Dose	6433	-
ALT-801 0.040 mg/kg/Dose	9117	-
ALT-801 0.080 mg/kg/Dose	1125	-

Secondary/protocol endpoint

Immunogenicity of ALT-801

Time frame:24 months

Immunogenicity (ADA)

descriptive

Posted result

Group	Mean · titer	95% CI
ALT-801 0.015 mg/kg/Dose	347	-
ALT-801 0.040 mg/kg/Dose	5483	-
ALT-801 0.080 mg/kg/Dose	762	-

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Clinical Antitumor Response to ALT-801

Time frame:24 months

threshold achievement, improvement

Posted result

Group	Number · participants	95% CI
ALT-801 0.015 mg/kg/Dose	2	-
ALT-801 0.040 mg/kg/Dose	5	-
ALT-801 0.080 mg/kg/Dose	3	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Clinical cancer research : an official journal of the American Association for Cancer Research2011 Dec 15PMID21994418doi:10.1158/1078-0432.CCR-11-1817via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.