FDA clears IND for Ph 1/2 Trial of ABT-301 Triplet Therapy for Advanced CRC
FDA has approved the Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 clinical trial in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia. Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene).
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