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This trial accepts CRC patients who are receiving Folfox/Folfoxiri ± bevacizumab as first line of therapy to treat metastatic disease, have completed at least two cycles of chemotherapy and experimenting cachexia. Patients will remain enrolled until they start 2nd-line systematic anticancer therapy.
AV-380, the study drug, is added to standard of care chemotherapy.

AV-380 (rilogrotug): humanized inhibitory IgG1 antibody targeting growth differentiation factor 15 (GDF-15).

GDF-15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia. This has been observed in actual patients and also in several animal models of cancer cachexia. The evidence suggests that a pro-inflammatory state may be responsible for many of the symptoms associated with cachexia.

Preclinical data show that inhibition of GDF-15 results in a switch from catabolism to anabolism, suggesting that GDF-15 inhibition with AV-380 may reverse the effects of cachexia. It has the potential of contributing to restore immune functions, suppressed in a pro-inflammatory state.

AV-380 added to standard of care therapy may allow patients to remain on therapy longer by reducing cachexia and from the drug’s anti-cancer effects.

Trial was highlighted in Clinical Trial Conversation blog in July 2023; trial is not randomized, all the participants receive the experimental drug, at different doses.

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Inclusion Criteria

Inclusion Criteria:

1. Patient must be ≥ 18 years of age at the time of signing the informed consent.
2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.
3. Patients with cachexia as defined by Fearon criteria:

1. Weight loss > 5% over past 6 months (in absence of simple starvation), or
2. BMI < 20 kg/m2 and any degree of weight loss > 2%, or
3. Sarcopenia and any degree of weight loss > 2%
4. Patients with life expectancy ≥ 3 months

Exclusion Criteria

Exclusion Criteria:

1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
2. 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.
3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy
4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
5. Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.
6. Patients receiving tube feedings or parenteral nutrition at the time of Screening.