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A clinical trial to evaluate the safety and preliminary efficacy of GEN1079 in participants with certain advanced solid tumors.
THE TRIAL CONSISTS OF 3 PARTS. THE OBJECTIVE OF PART 1 IS TO ASSESS THE SAFETY OF GEN1079 AT INCREASING DOSES AND TO IDENTIFY THE DOSES TO BE USED IN SUBSEQUENT PHASES. THE OBJECTIVE OF PART 2 IS TO REFINE AND IDENTIFY THE DOSE THAT IS EFFECTIVE WHILE CAUSING THE FEWEST SIDE EFFECTS. THE GOAL OF PART 3 IS TO FURTHER INVESTIGATE WHETHER GEN1079 WORKS AGAINST THE TUMOR AND HOW IT DOES SO, AND TO CONTINUE LEARNING ABOUT ITS SIDE EFFECTS.
Technical Summary
- A PHASE I, OPEN-LABEL, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY AND PRELIMINARY EFFICACY OF GEN1079 IN PARTICIPANTS WITH CERTAIN ADVANCED SOLID TUMORS.
- Code EudraCT: 2025-523931-21
- Protocol number: GCT1079-01
- Promoter: Genmab A/S
- Molecule/Drug: GEN1079
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