BridgeMD
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
EU CTIS ID: 2023-507469-24-00
What this study is testing
Part 1: Dose Escalation To evaluate the safety and tolerability of ascending doses of elritercept in participants with very low, low, or intermediate risk MDS in order to determine the dose(s) that will be evaluated in Part 2 of the study. Part 2: Dose Confirmation To confirm the safety and tolerability of the dose(s) selected in Part 1. Long-Term Extension To evaluate the long-term safety and tolerability of elritercept in participants with very low, low, or intermediate risk MDS in the Long term Extension (LTE).
- 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
- Diagnosis of MDS (Parts 1 and 2) according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
- < 5% blasts in bone marrow during the Pretreatment Period.
- Peripheral blood white blood cell (WBC) count < 13,000/μL during the Pretreatment Period.
- Anemia defined as: A). In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL during the Pretreatment Period OR B).a. In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period OR C). In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
- Females of child-bearing potential and sexually active males must agree to use highly effective methods of contraception.
You likely can't join if
- Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
- Treatment history: Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment history: Treatment with ESA within 8 weeks prior to C1D1 (or C5D1 for the Part 1 Extension).
- Treatment history for part 2: Prior treatment with luspatercept (Cohorts A, B, C, D, E, and F only)
- Treatment history: Prior or concurrent chronic treatment with granulocyte colony stimulating factor (G-CSF) orgranulocyte-macrophage colony stimulating factor (GM-CSF), for reasons other than the treatment of MDS.
- Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
See the full eligibility criteria
- Diagnosis of MDS (Parts 1 and 2) according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.
- < 5% blasts in bone marrow during the Pretreatment Period.
- Peripheral blood white blood cell (WBC) count < 13,000/μL during the Pretreatment Period.
- Anemia defined as: A). In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL during the Pretreatment Period OR B).a. In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period OR C). In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).
- Females of child-bearing potential and sexually active males must agree to use highly effective methods of contraception.
- Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.
- Treatment history: Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.
- Treatment history: Treatment with ESA within 8 weeks prior to C1D1 (or C5D1 for the Part 1 Extension).
- Treatment history for part 2: Prior treatment with luspatercept (Cohorts A, B, C, D, E, and F only)
- Treatment history: Prior or concurrent chronic treatment with granulocyte colony stimulating factor (G-CSF) orgranulocyte-macrophage colony stimulating factor (GM-CSF), for reasons other than the treatment of MDS.
- Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
- Transferrin saturation < 15%.
- Ferritin < 50 μg/L.
- Folate < 4.5 nmol/L (< 2.0 ng/mL).
- Vitamin B12 < 148 pmol/L (< 200 pg/mL).
- Estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
- Pregnant or lactating females.
- For Cohort G ONLY (for part 2): 1. Any luspatercept related AE Grade ≥ 3 that has not resolved to baseline or Grade ≤1 2. No history of allergy/anaphylaxis/hypersensitivity to luspatercept. 3. No prior treatment with imetelstat.
- Medical history: Diagnosis of MDS with deletion of chromosome 5q (Del5q).
- Medical history: Presence of uncontrolled heart disease or New York Heart Association Class III or IV heart failure.
- Medical history: Presence of uncontrolled hypertension (Grade >/= 2 high blood pressure).
- Diagnosis of secondary MDS (ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Medical history: Any malignancy other than MDS that has not been in remission and/or has required systemictherapy 1 year prior to C1D1 (or C5D1 for the Part 1 Extension).
- Medical history: History of solid organ or hematological transplantation
- Medical history: Body mass index >/= 40 kg/m2 during the pretreatment period.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- New Zealand
- Israel
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 Australia; United States; New Zealand; Israel. 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.