Trial results for a Phase 2 study (NCT04032704) investigating ladiratuzumab vedotin alone and in combination with pembrolizumab in advanced solid tumors were posted on ClinicalTrials.gov on 2025-03-10. The study was terminated, with results for ladiratuzumab vedotin showing objective response rates (ORR) ranging from 0% to 20% across various cohorts.
Background
The study, titled "A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors," aimed to evaluate the efficacy and safety of ladiratuzumab vedotin alone and in combination with pembrolizumab for treating various types of solid tumors. It also sought to identify potential side effects associated with the treatments.
Trial design
The Phase 2 study (NCT04032704) enrolled 205 participants with advanced solid tumors, including Small Cell Lung Cancer, Non-small Cell Lung Cancer, Squamous, Non-small Cell Lung Cancer, Non-squamous, Head and Neck Squamous Cell Carcinoma, and Esophageal Squamous Cell Carcinoma. The trial investigated ladiratuzumab vedotin alone and in combination with pembrolizumab. The study was ultimately terminated.
Key results
The trial reported Objective Response Rates (ORR) as determined by the investigator according to RECIST v1.1 for various cohorts receiving ladiratuzumab vedotin:
- For Part A, where participants received ladiratuzumab vedotin 2.5 mg/kg:
- Cohort 1: ORR was 10%.
- Cohort 2: ORR was 0%.
- Cohort 3: ORR was 8%.
- Cohort 4: ORR was 14%.
- Cohort 5: ORR was 20%.
- Cohort 6: ORR was 8%.
- For Part B, where participants received ladiratuzumab vedotin 1.25 mg/kg:
- Cohort 1: ORR was 6%.
- Cohort 2: ORR was 13%.
- Cohort 3: ORR was 11%.
- Cohort 4: ORR was 0%.
- Cohort 5: ORR was 18%.
- Cohort 6: ORR was 14%.
What this means
The termination of this Phase 2 study, coupled with the reported objective response rates for ladiratuzumab vedotin ranging from 0% to 20% across different cohorts and dosages, indicates that the efficacy of ladiratuzumab vedotin as a monotherapy in these advanced solid tumors may not have met the criteria for continued development in this specific trial design. While pembrolizumab was an intervention in the study, the detailed outcome measurements provided relate specifically to ladiratuzumab vedotin alone. The results contribute to the understanding of ladiratuzumab vedotin's activity in these challenging cancer types.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04032704, titled "A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors," were posted on 2025-03-10 on clinicaltrials.gov.