Trial Title:
A Dose Escalation Study of AV-380 in Metastatic Cancer Patients With Cachexia
NCT ID:
NCT05865535
Condition:
Cachexia
Conditions: Official terms:
Neoplasm Metastasis
Wasting Syndrome
Cachexia
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
AV-380
Description:
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.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Arm group label:
Cohort 5
Summary:
This open label ascending dose study is designed to evaluate the safety, pharmacokinetics
(PK), pharmacodynamics (PD), and immunogenicity of AV-380 in metastatic 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient must be ≥ 18 years of age at the time of signing the informed consent.
2. Patients with histologically confirmed metastatic CRC or pancreatic cancer, who are
actively receiving SoC chemotherapy in the first line setting for metastatic
disease; eligible patients must have completed at least 2 Cycles of chemotherapy to
eligible:
1. CRC patients who are receiving FOLFOX/FOLFOXIRI ± bevacizumab
2. Pancreatic cancer patients who are receiving FOLFOX/FOLFIRINOX
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:
1. Significant clinical manifestation of any allergic, dermatological, hepatic, renal,
hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological,
or psychiatric disorders (e.g., anorexia nervosa).
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. Significant cardiovascular disease, including myocardial infarction within 3 months
prior to start of protocol therapy.
4. Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within
the Screening period prior to the first dose of study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Advent Health Orlando Hospital
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Corina Mattix
Phone:
407-303-1327
Email:
Corina.mattix@adventhealth.com
Contact backup:
Last name:
Iman Boudlal
Email:
iman.boudlal@adventhealth.com
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Atlanta
Zip:
30318
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taiwo Obembe
Phone:
404-835-6799
Email:
TObembe@piedmontcancerinstitute.com
Contact backup:
Last name:
Summer Zamadie
Email:
SZamadie@piedmontcancerinstitute.com
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Atlanta
Zip:
30328
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taiwo Obembe
Phone:
404-835-6799
Email:
TObembe@piedmontcancerinstitute.com
Contact backup:
Last name:
Summer Zamdie
Email:
SZamadie@piedmontcancerinstitute.com
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Fayetteville
Zip:
30214
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taiwo Obembe
Phone:
404-835-6799
Email:
TObembe@piedmontcancerinstitute.com
Contact backup:
Last name:
Summer Zamadie
Email:
SZamadie@piedmontcancerinstitute.com
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Newnan
Zip:
30265
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taiwo Obembe
Phone:
404-835-6799
Email:
TObembe@piedmontcancerinstitute.com
Contact backup:
Last name:
Summer Zamadie
Email:
SZamadie@piedmontcancerinstitute.com
Facility:
Name:
Piedmont Cancer Institute
Address:
City:
Stockbridge
Zip:
30281
Country:
United States
Status:
Recruiting
Contact:
Last name:
Taiwo Obembe
Phone:
404-835-6799
Email:
TObembe@piedmontcancerinstitute.com
Contact backup:
Last name:
Summer Zamadie
Email:
SZamadie@piedmontcancerinstitute.com
Facility:
Name:
New York Cancer And Blood Specialists
Address:
City:
Babylon
Zip:
17702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Nemeth
Phone:
631-648-2321
Email:
jnemeth@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
North Shore Hematology Oncology Associates P.C. dba NY Cancer and Blood Specialists
Address:
City:
Bronx
Zip:
10469
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sujey Diaz
Phone:
971-732-4073
Email:
sudiaz@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
New York
Zip:
10028
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carissa Pederson
Phone:
917-258-7633
Email:
cpedersen@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
New York Cancer And Blood Specialists
Address:
City:
Patchogue
Zip:
11772
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Nemeth
Phone:
631-648-2321
Email:
jnemeth@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Nemeth
Phone:
631-648-2321
Email:
jnemeth@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
New York Cancer And Blood Specialists
Address:
City:
Riverhead
Zip:
11901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Nemeth
Phone:
631-648-2321
Email:
jnemeth@nycancer.com
Contact backup:
Last name:
Megan Stahl
Email:
mstahl@nycancer.com
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emily Michelich
Phone:
216-286-3357
Email:
Emily.Michelich@UHhospitals.org
Contact backup:
Last name:
Megan Boland
Email:
Megan.Boland@UHhospitals.org
Facility:
Name:
MUSC Hollings Cancer Center
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carly Fecio
Phone:
843-792-3479
Email:
fecio@musc.edu
Contact backup:
Last name:
Bria Sanders
Email:
sandebri@musc.edu
Facility:
Name:
Medical Oncology Associates
Address:
City:
Spokane Valley
Zip:
99216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Andrews
Phone:
509-462-2273
Email:
Ashley.Connors@aoncology.com
Contact backup:
Last name:
Sophie Miller
Email:
Sophie.Miller@aoncology.com
Facility:
Name:
Medical Oncology Associates
Address:
City:
Spokane
Zip:
99208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Andrews
Phone:
509-462-2273
Email:
Ashley.Connors@aoncology.com
Contact backup:
Last name:
Sophie Miller
Email:
Sophie.Miller@aoncology.com
Start date:
June 13, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
AVEO Pharmaceuticals, Inc.
Agency class:
Industry
Source:
AVEO Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05865535
