DelfaGLP-1 Atlas

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CompletedPhase 1, PHASE2

QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

8

Recruiting sites

—

Enrollment

25

actual

Study population

Oncology

Key I/E criterion

—

Primary endpoints

•Safety of the ALT-801-Cisplatin regimen•Objective response (OR) which includes CR and PR•Clinical benefit (CB) of the ALT-801-Cisplatin regimen which includes CR (complete response, partial response, stable disease)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01029873
Org study IDCA-ALT-801-02-09
Secondary IDR44CA097550

Timeline

Milestones

Study first posted2009-12-10estimated
Last update posted2016-10-27estimated
Study start2010-02 (month precision)
Primary completion2011-11actual (month precision)
Study completion2013-09actual (month precision)

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

Oncology

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

•Locally advanced or metastatic melanoma
•Measurable
•Histologically or cytologically confirmed
•Surgically incurable
•HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes

PRIOR/CONCURRENT THERAPY:

•If prior Proleukin treatment, must have had clinical benefit
•No prior systemic cytotoxic chemotherapy for melanoma
•No concurrent radiotherapy, chemotherapy, or other immunotherapy
•More than 4 weeks since prior major radiotherapy
•More than 8 weeks since prior CTLA-4 antagonist immunotherapy
•Not receiving other investigational agents

PATIENT CHARACTERISTICS:

Life expectancy

•> 3 months

Performance status

•ECOG 0 or 1

Bone marrow reserve

•Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL
•Platelets ≥100,000/uL
•Hemoglobin ≥ 10g/dL

Renal function

•Serum creatinine ≤ 1.5 mg/dL

Hepatic function

•Total bilirubin ≤ 1.5 X ULN
•AST ≤ 2.5 X ULN
•Alkaline phosphatase ≤ 2.5 X ULN
•PT INR ≤ 1.5 X ULN
•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:
–Age ≥ 50
–History of abnormal EKG
–Symptoms of cardiac ischemia or arrhythmia

Pulmonary

•Normal pulmonary function test (FEV1 ≥ 70% 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 CNS disease
•No active systemic infection requiring parental antibiotic therapy
•No systemic steroid therapy required
•No prior organ allograft or allogeneic transplantation
•Not receiving chronic medication for asthma
•Not pregnant or nursing
•Fertile patients must use effective contraception

Endpoints (6)

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
3
Cardiovascular outcomes
1
Other clinical outcomes
1
Other (unclassified)
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

To assess the six-month and one-year survival rates.

Time frame:12 months

All-cause death

threshold achievement, event

SNOMED 419620001

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint/low confidence

To evaluate the safety of the ALT-801-Cisplatin regimen.

Time frame:12 months

descriptive

Primary/protocol endpoint

To determine the MTD of the ALT-801-Cisplatin regimen.

Time frame:7 weeks

descriptive

Secondary/protocol endpoint

To evaluate the immunogenicity and pharmacokinetic profile of ALT-801.

Time frame:2 months

descriptive

componentsImmunogenicity (ADA), Plasma concentration (steady state)

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

To assess the clinical benefit (CB) of the ALT-801-Cisplatin regimen which includes CR, PR and SD.

Time frame:3 months

categorical status, improvement

componentscomplete response, partial response, stable disease

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

To assess the objective response (OR) which includes CR and PR.

Time frame:3 months

categorical status, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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 1, 2026 snapshot.