Nxera's HTL0039732 Enters Phase 2a Clinical Trial for Advanced Solid Tumors
Nxera Pharma Co., Ltd. and Cancer Research UK have announced that the first patient has been dosed in a Phase 2a clinical trial evaluating the investigational immunotherapy drug HTL0039732 for advanced solid tumors. The trial, which is sponsored and managed by Cancer Research UK's Centre for Drug Development, aims to assess the efficacy and safety of HTL0039732 in combination with atezolizumab in patients with microsatellite stable colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer.
Key Takeaways:
- The Phase 1 part of the trial identified a safe and well-tolerated dose of HTL0039732, a novel EP4 antagonist, in combination with checkpoint inhibitor atezolizumab, which achieved good engagement of the intended target EP4 without significantly engaging EP2.
- The Phase 1 trial showed encouraging early efficacy, including two confirmed partial responses in two distinct tumor types when administered in combination with atezolizumab.
- The Phase 2a trial will be expanded to four cohorts of patients with specific types of cancer, including microsatellite stable colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer.
- Nxera holds a license to the results generated under the trial to continue the clinical development and commercialization of HTL0039732.
- The trial's lead site is Addenbrooke's Hospital, Cambridge, and it is open for recruitment across several other sites across the Experimental Cancer Medicine Centre (ECMC) network.
Statistics:
- 30 active programs are being advanced by Nxera's unique NxWave
- discovery platform, which is focused on addressing major unmet needs in obesity and metabolic disorders, neurology/neuropsychiatry, and immunology and inflammation.
- Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland), and Seoul (South Korea).
- The Phase 2a trial will be conducted across multiple sites in the UK and Japan.
Sources:
- [1] Nxera Pharma Co., Ltd., 2025-09-17 ( joint press release with Cancer Research UK )
- [2] Cancer Research UK Centre for Drug Development, 2025-09-17 ( press release )