Trial results for the PHASE1/PHASE2 study (NCT03310957) investigating the combination of ladiratuzumab vedotin and pembrolizumab for patients with locally-advanced or metastatic triple-negative breast cancer were posted on ClinicalTrials.gov on 2025-12-12. The study, which enrolled 185 participants, detailed the number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) across various dosing regimens.
Background
Pembrolizumab (Keytruda) is an immunotherapy drug. This trial investigated its use in combination with ladiratuzumab vedotin for patients with locally-advanced or metastatic triple-negative breast cancer. The study aimed to understand the safety profile of this combination in this patient population.
Trial design
The study (NCT03310957) was a PHASE1/PHASE2 trial that enrolled 185 participants with locally-advanced or metastatic triple-negative breast cancer. The trial investigated the safety and efficacy of combining ladiratuzumab vedotin with pembrolizumab. The study aimed to identify the side effects associated with these two drugs and to determine if they work to treat this type of cancer.
Key results
The trial results detailed the number of participants experiencing adverse events across various dosing regimens of ladiratuzumab vedotin combined with pembrolizumab:
- For the outcome "Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)":
- In the Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab group, this was 32 participants.
- In the Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab group, this was 59 participants.
- In the Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab group, this was 2 participants.
- In the Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab group, this was 53 participants.
- In the Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab group, this was 36 participants.
- In the Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab group, this was also reported as 17 participants.
- In the Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab group, this was also reported as 35 participants.
- In the Part C: SGN-LIV 1.0 mg/kg (Q1WK) + Pembrolizumab group, this was also reported as 1 participant.
- In the Part C: SGN-LIV 1.25 mg/kg (Q1WK) + Pembrolizumab group, this was also reported as 28 participants.
- In the Part D: SGN-LIV 1.5 mg/kg (2Q3WK) + Pembrolizumab group, this was also reported as 14 participants.
- For the outcome "Number of Participants With Treatment Related TEAEs and SAEs":
- In the Part A, B: SGN-LIV 2.0 mg/kg (Q3WK) + Pembrolizumab group, this was 29 participants.
- In the Part A, B: SGN-LIV 2.5 mg/kg (Q3WK) + Pembrolizumab group, this was 58 participants.
What this means
The posted results provide initial safety data for the combination of ladiratuzumab vedotin and pembrolizumab in patients with locally-advanced or metastatic triple-negative breast cancer. The trial identified the number of participants experiencing various categories of treatment-emergent and treatment-related adverse events across different dosing regimens. This information is crucial for understanding the safety profile of this combination therapy in this patient population, guiding future clinical development and risk-benefit assessments.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03310957, titled "Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer," were posted on 2025-12-12 on clinicaltrials.gov.