Cachexia study: Ponsegromab
Official title A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue
ClinicalTrials.gov ID: NCT06989437
What this study is testing
What is ponsegromab?
ponsegromab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cachexia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding ponsegromab (a medicine) to chemotherapy is safe and works better than chemotherapy alone for adults with metastatic pancreatic cancer who have lost weight and feel very tired.
- Who it's for
- You may be able to join if you are an adult with metastatic pancreatic cancer, have lost weight and feel very tired.
- What's involved
- You would receive standard chemotherapy plus either ponsegromab or a pretend treatment with no medicine. You will have doctor visits and tests to check safety and how well it works.
- Time commitment
- The study lasts several months with regular visits during treatment and later check‑ins.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed Consent Document
- Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
- Cachexia defined by Fearon criteria of weight loss
- Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and...
- ECOG PS ≤1 with life expectancy of at least 4 months Key
You likely can't join if
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association...
- Left ventricular ejection fraction \<50%
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
See the full eligibility criteria
- Signed Informed Consent Document
- Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
- Cachexia defined by Fearon criteria of weight loss
- Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
- ECOG PS ≤1 with life expectancy of at least 4 months Key
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
- Left ventricular ejection fraction \<50%
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
- History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
- Inadequate liver function
- Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Bryant, Arkansas, United States
- Conway, Arkansas, United States
- Little Rock, Arkansas, United States
- North Little Rock, Arkansas, United States
- Pine Bluff, Arkansas, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Santa Rosa, California, United States
- Vista, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Athens, Georgia, United States
- Honolulu, Hawaii, United States
+ 144 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Bryant, Arkansas, United States; Conway, Arkansas, United States; Little Rock, Arkansas, United States; North Little Rock, Arkansas, United States and 158 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.