Health TrialsbyHealthPanel

A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia

ConditionCachexia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAVEO Pharmaceuticals, Inc.

About this trial

This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be ≥ 18 years of age at the time of signing the informed consent.

Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.

Weight loss > 5% over past 6 months (in absence of simple starvation), or

BMI < 20 kg/m2 and any degree of weight loss > 2%, or

Disqualifiers

History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.

Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy

Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

Trial design

Design model

Sequential

Treatments tested in this trial

  • AV-380

    Biological/Vaccine

    AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Dose Escalation CohortsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of adverse events (AEs)

AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\])

Time frame
From enrollment to the last follow-up visit approximately 60-days post dose
2

Toxicity

Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380

Time frame
While receiving study drug (up to 4 months)
3

Laboratory Abnormalities

Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.

Time frame
From enrollment to the last follow-up visit approximately 60-days post dose.

Secondary outcomes

1

Cmax

Maximum observed plasma concentration for AV-380

Time frame
From first dose to the last follow-up visit approximately 60-days post dose.
2

Tmax

Time to reach the Cmax for AV-380

Time frame
From first dose to the last follow-up visit approximately 60-days post dose
3

AUC(0-t)

Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380

Time frame
From first dose to the last follow-up visit approximately 60-days post dose.

Other outcomes

1

Immunogenicity

Serum levels of Anti-Drug Antibody (ADA) against AV-380 and their potential relationship with AEs and serum levels of GDF-15

Time frame
From first dose to the last follow-up visit approximately 60-days post dose.
2

Weight

Change from baseline body weight during the study

Time frame
From enrollment to the last follow-up visit approximately 60-days post dose.
3

Patient-Reported Outcomes

Change from baseline in the following questionnaires: Functional Assessment of Anorexia Cachexia Therapy (FAACT); Patient global impression of severity (PGI-S) and patient global impression of change (PGI-C) for appetite, fatigue, and physical activity.

Time frame
From enrollment to the end of treatment, approximately 4 months
4

Lumbar (L3) Skeletal Muscle Index (L3SMI)

Measurement of a cross-sectional area of muscle at the level of the third lumbar vertebra (L3) using computed tomography (CT) scan

Time frame
From enrollment to the end of treatment, approximately 4 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AVEO Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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