Trial results for a Phase 1/2 study (NCT05070247) investigating TAK-500 with or without Pembrolizumab (Keytruda) in adults with select locally advanced or metastatic solid tumors were posted on ClinicalTrials.gov on 2026-01-22. The study, which was terminated, reported safety data, specifically the number of participants experiencing one or more treatment-emergent adverse events (TEAEs) across various dose escalation groups.
Background
The study investigated TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. Pembrolizumab is also known by its brand name, Keytruda. The trial focused on conditions including Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, and Gastric Cancer.
Trial design
The Phase 1/2 study, NCT05070247, titled "A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors," was designed to assess the safety profile and anti-tumor effects of TAK-500 when given alone and in combination with pembrolizumab. The trial enrolled 61 participants and was ultimately terminated. Conditions studied included Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, and Gastric Cancer. Interventions involved TAK-500, pembrolizumab, tocilizumab, and dexamethasone. The study's primary outcomes were not listed in the posted results.
Key results
The posted results focused on safety data, specifically the "Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)" during dose escalation. The counts of participants reporting TEAEs across various groups were:
- Single Agent Dose Escalation: TAK-500 8 µg/kg: 3 Participants
- Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg: 3 Participants
- Single Agent Dose Escalation: TAK-500 16 µg/kg: 5 Participants
- Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg: 3 Participants
- Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg: 3 Participants
- Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg: 7 Participants
- Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg: 3 Participants
- Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg: 2 Participants
- Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg: 6 Participants
- Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg: 4 Participants
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg: 5 Participants
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg: 5 Participants
What this means
The posting of these results, particularly the counts of treatment-emergent adverse events, provides initial safety insights from the terminated Phase 1/2 study. The termination of the trial suggests that further development of TAK-500, either alone or in combination with pembrolizumab, in these specific solid tumor indications may not be proceeding as initially planned. The detailed counts of TEAEs across different dose levels and combinations contribute to the overall safety profile understanding of these agents.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05070247, titled "A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors," were posted on 2026-01-22 on clinicaltrials.gov.