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Monoclonal Antibodies

AV-380 for Cachexia

Phase 1

Recruiting

Research Sponsored by AVEO Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients with cachexia as defined by Fearon criteria: 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 Sarcopenia and any degree of weight loss > 2%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies an antibody that targets a protein linked to cancer-induced cachexia in metastatic cancer patients.

Who is the study for?

This trial is for metastatic cancer patients with cachexia, which means significant weight loss due to illness. They must have a life expectancy of at least 3 months and be undergoing first-line chemotherapy for colorectal or pancreatic cancer. Participants need to be adults who've completed at least two chemo cycles and can't join if they have untreated brain tumors, recent heart issues, severe allergies or organ problems.

What is being tested?

AV-380, an antibody designed to target a specific protein (GDF-15) related to cachexia in cancer patients, is being tested. The study will gradually increase the dose given to participants while monitoring safety, how the body processes the drug (PK), its effects on the body (PD), and any immune response against it.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions associated with monoclonal antibodies such as infusion-related reactions, allergic responses, fatigue or flu-like symptoms. Since AV-380 targets GDF-15 involved in weight regulation, unintended impacts on weight might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have lost more than 5% of my weight in the last 6 months, or my BMI is below 20 with any weight loss, or I have muscle loss with any weight loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC(0-t)

Assessment of adverse events (AEs)

Cmax

+1 more

Secondary study objectives

6-minute walk test

Handgrip test

Immunogenicity

+3 more

Other study objectives

Best objective response (BOR)

Biomarkers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment1 Intervention

IV infusion AV-380. This cohort will proceed at a new dose level with approval of the Dose Escalation Committee, after evaluation of data from the previous cohort. IV infusion AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.

Group II: Cohort 4Experimental Treatment1 Intervention

Group III: Cohort 3Experimental Treatment1 Intervention

Group IV: Cohort 2Experimental Treatment1 Intervention

Group V: Cohort 1Experimental Treatment1 Intervention

IV infusion of AV-380. 7 doses will be given -- the 2nd dose will be 28 days after the first dose, the remaining 5 doses will be given every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AV-380

2021

Completed Phase 1