China-based CStone Pharmaceuticals (HKG: 2616) has announced a Phase Ib clinical filing in Australia for its ROR1-targeted antibody-drug conjugate (ADC), CS5001, in combination with first-line standard-of-care (SoC) for diffuse large B-cell lymphoma (DLBCL). The move underscores the company’s commitment to expanding the therapeutic potential of CS5001 across hematologic and solid tumor malignancies.
Phase Ib Trial Design
The Phase Ib trial is designed to evaluate the safety and efficacy of CS5001 in combination with first-line SoC in DLBCL, as well as in monotherapy and in combination with a PD-L1 inhibitor in advanced solid tumors. The trial aims to enroll patients across all DLBCL stages, including those who have not received prior systemic therapy, patients with relapsed or refractory DLBCL, and those with ROR1-expressing solid tumors.
Global Multi-Center Study Progress
Meanwhile, a global multi-center study for CS5001 as a monotherapy and in combination with a PD-L1 inhibitor in advanced solid tumors is well underway. This study is designed to further explore the potential of CS5001 in treating a broad range of malignancies, with a focus on ROR1-expressing tumors. The combination with PD-L1 inhibitors represents a promising approach to enhancing anti-tumor activity through complementary mechanisms of action.-Fineline Info & Tech
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