A Phase 1/2 Multi-Center Open-Label Study to Evaluate the Safety Tolerability and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination with a PARP Inhibitor in Patients with BRCA 1/2 Mutant or Other HRD+ Advanced or Metastatic S

Brief description of study

This study is split into two parts: Phase 1 and Phase 2. The study team is testing a new medicine, TNG348, for patients with tumors that have specific types of mutations related to defects in DNA repair and have certain advanced and spread-out cancers. In Phase 1, the study team will try out different doses of TNG348 alone and mixed with another medicine, olaparib, to see which dosage has few side effects for patients. The study team will use special methods to figure out the right doses and adjust them as they gather more data and information throughout the study. In Phase 2, the study team will give the medicine to more people using the doses with few side effects they found in Phase 1. They'll also check if the medicine helps treat cancer effectively. Phase 2 will have different groups of people getting either TNG348 alone or combined with olaparib, and the study team will watch how patients respond to the treatment.

Clinical Study Identifier: s23-01229

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