FDA Clears IND application for Ph 1/2 Trial of ABT-301 Triplet Therapy for Advanced CRC
Anbogen Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved its 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). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024.
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us