GLP-1 Peptide Atlas, by Delfa

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TerminatedPhase 1, PHASE2Results posted

QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Oncology

Key I/E criterion

•EF ≤50%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01670994

Org study IDCA-ALT-801-01-11

Timeline

Milestones

Study start2012-08-14actual

Study first posted2012-08-23estimated

Primary completion2015-09-09actual

Study completion2015-09-09actual

Last update posted2024-06-18actual

Results first posted2024-06-18actual

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 CHARATERISTICS:

•Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.

–Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy.

–Progressive disease is defined by a 25% increase from the lowest response value in specified tests.

•Measurable disease as defined by at least one of the following:

–Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)

–Urine M-protein ≥ 200mg/24hours

–Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio

PRIOR/CONCURRENT THERAPY:

•No anti-myeloma treatments within 28 days before the start of study treatment.

•Must have recovered from side effects of prior treatments.

PATIENT CHARACTERISTICS:

Age

• ≥ 18 years

Performance Status

• ECOG 0, 1, or 2

Bone Marrow Reserve

•Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL

•Platelets ≥ 30,000/uL

•Hemoglobin ≥ 8g/dL

Renal Function

• Glomerular Filtration Rate (GFR) > 45mL/min/1.73m^2

Hepatic Function

•Total bilirubin ≤ 2.0 X ULN

•AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist)

Cardiovascular

•No congestive heart failure < 6 months

•No unstable angina pectoris < 6 months

•No myocardial infarction < 6 months

•No history of ventricular arrhythmias

•No history of supraventricular arrhythmias

•No NYHA Class > II CHF

•Normal Transthoracic Echocardiogram (TTE) is required for patients with history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or with a history of having received adriamycin or doxorubicin

•Patients with a left ventricular ejection fraction (LVEF) of less than 50% will be excluded from study entry

Pulmonary

• Normal clinical assessment of pulmonary function

Other

•Negative serum pregnancy test if female and of childbearing potential

•Women who are not pregnant or nursing

•Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study

•No known autoimmune disease other than corrected hypothyroidism

•No known prior organ allograft or allogeneic transplantation

•Not HIV positive

•No history or evidence of uncontrollable CNS disease

•No psychiatric illness/social situation

•No other illness that in the opinion of the investigator would exclude the subject from participating in the study

•Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

•Active systemic infection requiring parenteral antibiotic therapy.

•No ongoing chronic systemic steroid therapy required.

Endpoints (1)

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.

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Participants With Treatment-Related Adverse Events

Time frame:7 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
ALT-801 0.04mg/kg	3	—
ALT-801 0.06mg/kg	3	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.