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- ||| PE0116 / HyaMab
Enrollment open, Trial initiation date, Metastases: PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - Dec 14, 2023
P1/2, N=120, Recruiting, Sponsor: Shanghai HyaMab Biotech Co.,Ltd.
Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Sep 2023
- || PE0116 / HyaMab
Trial completion: PE0116 Injection in Treatment of Patients With Advanced Solid Tumours (clinicaltrials.gov) - Dec 12, 2023
P1, N=31, Completed, Sponsor: Shanghai HyaMab Biotech Co.,Ltd.
Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Sep 2023 Active, not recruiting --> Completed
- |||| PE0105 / Shanghai Yunyi Health Technology, PE0116 / HyaMab
New P1/2 trial, Metastases: A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - Sep 7, 2023
P1/2, N=120, Not yet recruiting, Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.
- |||| PE0116 / HyaMab
New P1/2 trial, Metastases: PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor (clinicaltrials.gov) - Apr 6, 2023
P1/2, N=120, Not yet recruiting, Sponsor: Shanghai HyaMab Biotech Co.,Ltd.
- || PE0116 / HyaMab
New P1 trial, Metastases: PE0116 Injection in Treatment of Patients With Advanced Solid Tumours (clinicaltrials.gov) - Apr 5, 2023
P1, N=31, Active, not recruiting, Sponsor: Shanghai HyaMab Biotech Co.,Ltd.
- | utomilumab (PF-05082566) / Pfizer, PE0116 / HyaMab, urelumab (BMS-663513) / BMS, Ono Pharma
Journal: Development and characterization of a novel human CD137 agonistic antibody with anti-tumour activity and a good safety profile in non-human primates. (Pubmed Central) - Oct 1, 2022
In vivo, PE0116 exhibits a good safety profile and has typical pharmacokinetic characteristics of an IgG antibody in preclinical studies of non-human primates. In summary, PE0116 is a promising anti-CD137 antibody with a good safety profile in preclinical studies.
- PE0116 / HyaMab
First-in-human/phase I trial of PE0116 (4-1bb Ig G4 McAb) as single agent in patients with solid tumors progressed after lines of therapies in China. (Available On Demand; 295) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1700;
Preliminary data are very encouraging as single agent HE0116 showed durable responses with 1 iPR, 4 iSD in several difficult to treat late-stage cancer pts. Dose escalation is ongoing as per study protocol.