Phase Ia/Ib trial of the safety and efficacy of mobocertinib in combination with T-DM1 for patients with HER2-mutant solid tumors (WJOG16022M) - PubMed
9 hours ago
- #HER2-mutant
- #phase I trial
- #combination therapy
- The study evaluated mobocertinib plus T-DM1 for HER2-mutant solid tumors, finding the combination feasible with potential efficacy.
- In dose escalation, DLT occurred at 120 mg mobocertinib, leading to a recommended dose of 80 mg mobocertinib plus 3.6 mg/kg T-DM1.
- Grade ≥3 adverse events, such as decreased platelet count, diarrhea, and hypokalemia, affected 75.0% of patients but were manageable.
- In part Ib, the confirmed objective response rate was 28.6%, and median progression-free survival was 3.3 months for 21 evaluable patients.
- This is the first clinical trial investigating a HER2-TKI and anti-HER2 ADC combination for HER2-mutant solid tumors.