BridgeMD
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
EU CTIS ID: 2025-522093-36-00
What this study is testing
1. To evaluate the effect of ponsegromab compared with placebo on body weight. 2. To evaluate the effect of ponsegromab compared with placebo on the appetiterelated symptoms as measured by FAACT-5IASS 3. Primary (OLE): To evaluate the effect of ponsegromab on body weight
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥18 years of age (or the minimum age of consent in accordance with local regulations if >18 years) at the Screening Visit.
- Documented histologic or cytologic active diagnosis of mPDAC (locally advanced disease is not eligible) • Measurable disease; participant has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media) according to RECIST v 1.1. and: • Completed 1 × 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 × 14-day cycles of FOLFIRINOX chemotherapy and must be prior to receiving the next cycle of nab-paclitaxel plus gemcitabine chemotherapy or FOLFIRINOX chemotherapy.
- Cachexia as defined by Fearon criteria (see Section 8.1.1 for details on documented body weight from medical records): • BMI < 20 kg/m2 and involuntary weight loss of > 2% within 6 months prior to screening • Involuntary weight loss of >5% over the past 6 months prior to screening irrespective of BMI
- Participants who are assessed by the investigator to have: • an ECOG PS ≤1 and • a life expectancy of ≥4 months.
- Evidence of personally signed and dated ICD indicating that the participant has been informed of and comprehended all pertinent aspects of the trial.
- Participant has been evaluated and determined that available anticachexic treatments have either been administered with no positive effect or the participant is not suitable for these treatments.
You likely can't join if
- Medical Conditions: Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to: • NCI CTCAE Grade 3 or 4 oral mucositis • NCI CTCAE Grade 3 or 4 GI disorders (nausea, vomiting, diarrhea, and constipation) • Mechanical obstructions interfering with the participant's ability to eat
- History of severe liver disease or cirrhosis, unrelated to metastatic cancer. Potential participants with the following liver function test abnormalities will also be excluded; results may be confirmed by a single repeat test, if necessary: • Total bilirubin ≥1.5 × ULN (For Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) • AST 3 × ULN (AST 5× ULN if there is liver involvement by the tumor) • ALT 3 × ULN (ALT 5× ULN if there is liver involvement by the tumor) • Alkaline phosphatase 3 x ULN (Alkaline phosphatase 5× ULN if there is liver involvement by the tumor and/or in case of bone metastases, or if considered related to prior surgery eg, pancreaticoduodenectomy).
- Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >470 ms).
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Left ventricular ejection fraction <50% on echocardiogram (or MUGA scan).
- Other Exclusion Criteria: Current adherence to a calorie-restricted diet with the intention of weight loss within 6 months prior to Screening/Visit 1
See the full eligibility criteria
Who can join
- Aged ≥18 years of age (or the minimum age of consent in accordance with local regulations if >18 years) at the Screening Visit.
- Documented histologic or cytologic active diagnosis of mPDAC (locally advanced disease is not eligible) • Measurable disease; participant has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media) according to RECIST v 1.1. and: • Completed 1 × 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 × 14-day cycles of FOLFIRINOX chemotherapy and must be prior to receiving the next cycle of nab-paclitaxel plus gemcitabine chemotherapy or FOLFIRINOX chemotherapy.
- Cachexia as defined by Fearon criteria (see Section 8.1.1 for details on documented body weight from medical records): • BMI < 20 kg/m2 and involuntary weight loss of > 2% within 6 months prior to screening • Involuntary weight loss of >5% over the past 6 months prior to screening irrespective of BMI
- Participants who are assessed by the investigator to have: • an ECOG PS ≤1 and • a life expectancy of ≥4 months.
- Evidence of personally signed and dated ICD indicating that the participant has been informed of and comprehended all pertinent aspects of the trial.
- Participant has been evaluated and determined that available anticachexic treatments have either been administered with no positive effect or the participant is not suitable for these treatments.
What rules you out
- Medical Conditions: Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to: • NCI CTCAE Grade 3 or 4 oral mucositis • NCI CTCAE Grade 3 or 4 GI disorders (nausea, vomiting, diarrhea, and constipation) • Mechanical obstructions interfering with the participant's ability to eat
- History of severe liver disease or cirrhosis, unrelated to metastatic cancer. Potential participants with the following liver function test abnormalities will also be excluded; results may be confirmed by a single repeat test, if necessary: • Total bilirubin ≥1.5 × ULN (For Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) • AST 3 × ULN (AST 5× ULN if there is liver involvement by the tumor) • ALT 3 × ULN (ALT 5× ULN if there is liver involvement by the tumor) • Alkaline phosphatase 3 x ULN (Alkaline phosphatase 5× ULN if there is liver involvement by the tumor and/or in case of bone metastases, or if considered related to prior surgery eg, pancreaticoduodenectomy).
- Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >470 ms).
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Left ventricular ejection fraction <50% on echocardiogram (or MUGA scan).
- Other Exclusion Criteria: Current adherence to a calorie-restricted diet with the intention of weight loss within 6 months prior to Screening/Visit 1
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification.
- Cachexia caused by reasons other than mPDAC, as determined by the investigator, including, but not limited to: •Severe COPD requiring use of home O2 •Active, uncontrolled or untreated AIDS
- Undergoing major surgery (central venous access placement, endoscopic retrograde cholangiopancreatography with or without biliary stent placement, and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Participants must have recovered from acute effects of surgery prior to screening. Participants should not have plans to undergo major surgical procedures during the study.
- Clinically significant ascites that requires medical intervention or underwent a paracentesis within 4 weeks prior to randomization.
- History of any secondary malignancy in the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody.
- Participants who have a history of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients, or participants who exhibit any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the chemotherapeutic prescribing Information.
- Current or chronic HBV or HCV infection as evidenced by HBsAg and anti-hepatitis C antibody positivity, respectively, or known seropositivity for HIV.
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Symptomatic brain metastasis or leptomeningeal disease.
- Prior/Concomitant Therapy: Participants must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with chemotherapy in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no persistence of treatment-related toxicities are present.
- Current use of any prohibited concomitant medication(s) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study intervention. Refer to Section 6.9 for full details of prohibited and permitted medications.
- Prior/Concurrent Clinical Study Experience: Previous administration with an IP (drug, biologic agents, or vaccine) either within 30 days (or as determined by the local requirement) or 5 half lives, whichever is longer, preceding the first dose of study intervention used in this study through the duration of the study.
- Previous participation in a clinical study evaluating ponsegromab (including exposure to placebo).
- Diagnostic Assessments: Renal disease requiring dialysis or eGFR <30 mL/min/1.73m2 calculated using 2021 CKD-EPI equation described in Section 10.8.2.1.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- Brazil
- Mexico
- Taiwan
- Australia
- Korea, Republic of
- Canada
- India
- China
- Israel
- United States
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; Brazil; Mexico; Taiwan; Australia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.