BridgeMD
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
EU CTIS ID: 2023-510446-24-00
What this study is testing
To evaluate the effect of ponsegromab compared with placebo on body weight in participants with cancer, cachexia, and elevated concentrations of GDF-15.
- Therapeutic exploratory (Phase II)
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
- Participants aged ≥18 years (or the minimum age of consent if > 18 in accordance with local regulations) at screening who have signed informed consent. a. A female participant is eligible to participate if she is not pregnant or breastfeeding. b. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- Documented histologic or cytologic active diagnosis of NSCLC, PANC, or CRC and are currently receiving, or have completed, standard of care treatment for this cancer (which may include systemic therapy).
- Cachexia defined by Fearon criteria of weight loss as (See Section 8.1.1 for details if the participant’s body weight is unavailable from medical record): BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening; or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI.
- Serum GDF-15 concentrations of ≥1.5 ng/mL (as measured using the Investigational Use Only Roche Elecsys GDF-15 assay)10 at Screening.
- Participants who are assessed by the investigator to have: an ECOG PS ≤3, and; a life expectancy of at least 4 months to be able to complete Part A.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
You likely can't join if
- 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 study participants with the following liver function test abnormalities will be excluded; result may be confirmed by a single repeat test, if necessary:Total bilirubin ≥1.5 × ULN (except for Gilbert’s syndrome);AST >3 × ULN (AST > 5X ULN if there is liver involvement by the tumor); ALT >3 × ULN (ALT >5X ULN if there is liver involvement by the tumor). Alkaline phosphatase >3 x ULN (Alkaline phosphatase >5X ULN if there is liver involvement by the tumor and/or in case of bone metastases, or if considered related to prior surgery e.g. pancreaticoduodenectomy).
- Renal disease requiring dialysis.
- Current adherence to a calorie-restricted diet with the intention of weight loss.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
See the full eligibility criteria
Who can join
- Participants aged ≥18 years (or the minimum age of consent if > 18 in accordance with local regulations) at screening who have signed informed consent. a. A female participant is eligible to participate if she is not pregnant or breastfeeding. b. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- Documented histologic or cytologic active diagnosis of NSCLC, PANC, or CRC and are currently receiving, or have completed, standard of care treatment for this cancer (which may include systemic therapy).
- Cachexia defined by Fearon criteria of weight loss as (See Section 8.1.1 for details if the participant’s body weight is unavailable from medical record): BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening; or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI.
- Serum GDF-15 concentrations of ≥1.5 ng/mL (as measured using the Investigational Use Only Roche Elecsys GDF-15 assay)10 at Screening.
- Participants who are assessed by the investigator to have: an ECOG PS ≤3, and; a life expectancy of at least 4 months to be able to complete Part A.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
What rules you out
- 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 study participants with the following liver function test abnormalities will be excluded; result may be confirmed by a single repeat test, if necessary:Total bilirubin ≥1.5 × ULN (except for Gilbert’s syndrome);AST >3 × ULN (AST > 5X ULN if there is liver involvement by the tumor); ALT >3 × ULN (ALT >5X ULN if there is liver involvement by the tumor). Alkaline phosphatase >3 x ULN (Alkaline phosphatase >5X ULN if there is liver involvement by the tumor and/or in case of bone metastases, or if considered related to prior surgery e.g. pancreaticoduodenectomy).
- Renal disease requiring dialysis.
- Current adherence to a calorie-restricted diet with the intention of weight loss.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
- Cachexia caused by other reasons, as determined by the investigator, including, but not limited to: Severe COPD requiring use of home O2; NYHA class III-IV heart failure; AIDS.
- Undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must have recovered from acute effects of surgery prior to screening. Patient should not have plans to undergo major surgical procedures during the study.
- Other 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.
- Current use of any prohibited concomitant medication(s) within 4 weeks prior to first dose of study intervention. Refer to Section 6.9.
- Concurrent administration of investigational products (including drug, biologic agents, or vaccines) are not permitted within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) of the first dose of study intervention through the duration of the study (including both Part A and B). Refer to Section 6.9.
- Enrollment and previously dosed in a prior study with ponsegromab.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- China
- United States
- Canada
- Taiwan
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; China; United States; Canada; Taiwan. 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.