SYN-818 / SynRx Therap - LARVOL DELTA

Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd

New P1 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

SYN-818-101: Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA

SYN818 Shows Favorable Safety Profile in Locally Advanced or Metastatic Solid Tumors (OncLive) - P1 | N=30 | NCT06666270 | Sponsor: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd | "The DNA polymerase theta (POLQ) inhibitor SYN818 demonstrated an acceptable toxicity profile when administered as a single agent at doses of 50 mg, 100 mg, and 200 mg in patients with locally advanced or metastatic solid tumors enrolled in a first-in-human, phase 1 study (NCT06666270). Early data, shared at the 2025 AACR Annual Meeting, indicated that in the first 3 dosing cohorts, the most common adverse effects (AEs) reported with the monotherapy were grade 1 in severity, and no dose-limiting toxicities were reported. Moreover, no hematological toxicities that are typically experienced with DNA damage repair inhibitors were observed."

P1 data • Solid Tumor

A phase I study of POLQ inhibitor SYN818 as monotherapy in adult patients with locally advanced or metastatic solid tumors (AACR 2025) - P1 | "SYN818 has exhibited a favorable safety profile and PK characteristics when administered as a single agent at doses up to 100 mg. The preliminary safety profile supports its potential value in combination with PARPi and/or rational therapeutics modalities. As of the cut-off date, the MTD has not been reached, and enrollment is ongoing."

Clinical • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor • BRCA • BRCA1 • BRCA2 • HRD • POLQ • RAD51