SCB-219M / Sichuan Clover Biopharma - LARVOL DELTA

A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT) (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=76 ➔ 36 | Trial completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Breast Cancer • Hematological Disorders • Thrombocytopenia

A phase I clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and preliminary efficacy of SCB-219M in patients with chemotherapy-induced thrombocytopenia (CIT): An interim analysis. (ASCO 2024) - P1 | "Incidence of CIT can occur in about 15-25% of patients undergoing standard chemotherapy regiments with platinum, taxane and/or gemcitabine-based regimen. In this interim analysis, drug safety, PK profile and durable efficacy are expected to support SCB-219M dosing interval of ≥2-weeks or a single dosing regimen within a chemotherapy cycle. Accordingly, a Phase Ib trial evaluating repeated dosing of SCB-219M is planned to initiate in 2024. Clinical trial information: NCT05426369."

Clinical • P1 data • PK/PD data • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • Thrombocytopenia

A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT) (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia

Clover Announces Positive Phase I Results for SCB-219M for Treatment of Chemotherapy-Induced Thrombocytopenia (CIT) (PRNewswire) - P1 | N=76 | NCT05426369 | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | "Clover Biopharmaceuticals...announced positive preliminary safety, efficacy and pharmacokinetics data in a Phase I clinical trial evaluating SCB-219M, an innovative thrombopoietin receptor agonist (TPO-RA) mimetic bispecific Fc-fusion protein produced from CHO cells, for the treatment of cancer patients with chemotherapy-induced thrombocytopenia (CIT). All cancer patients enrolled to-date (n=9) receiving chemotherapy plus a single subcutaneous dose of SCB-219M observed platelet counts maintained or recovered at >75 x 109/L (threshold level for CIT) after one week, with responses durable through at least three weeks (i.e. through the chemotherapy cycle)....A Phase Ib trial evaluating repeated dosing of SCB-219M in CIT and CTIT patients is planned to initiate in 2024."

New P1 trial • P1 data • Thrombocytopenia

A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT) (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Solid Tumor • Thrombocytopenia

A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT) (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Sichuan Clover Biopharmaceuticals, Inc.

New P1 trial • Hematological Disorders • Solid Tumor • Thrombocytopenia

Clover Doses First Patient with SCB-219M in Phase 1 Trial for Chemotherapy-Induced Thrombocytopenia (GlobeNewswire) - "Clover Biopharmaceuticals, Ltd...announced that the first patient has been dosed with SCB-219M, an innovative thrombopoietin receptor agonist (TPO-RA) mimetic Fc-fusion protein, in a Phase 1 clinical trial to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and efficacy of SCB-219M in cancer patients with chemotherapy-induced thrombocytopenia (CIT)...Interim safety and recommendations for Phase II dosing is anticipated in the first half of 2023."

P1 data • Trial status • Oncology