Phase 1a1b Study of DR-0202 for Advanced or Metastatic Relapsed or Refractory Carcinomas

What this Trial Is About

This trial investigates DR-0202, a bispecific antibody, in patients with locally advanced or metastatic, relapsed or refractory carcinomas. It is a phase 1a1b, multicenter, open-label study focused on evaluating the safety and activity of DR-0202 in several types of epithelial cancers including breast, lung, cervical, prostate, pancreatic, head-and-neck, endometrial, ovarian, gastric, gastroesophageal-junction, and urothelial cancers. The study aims to provide information for patients who have relapsed or are refractory after at least two prior therapies and have no standard treatment options left. Participants will receive DR-0202 at varying dose levels DL1 through DL8 administered every two weeks until disease progression or withdrawal from the study. This dose escalation and expansion study allows researchers to explore multiple doses to assess safety and activity. The treatment continues for each participant until they either experience disease progression or choose to stop. Throughout the study, participants will undergo safety assessments focusing on treatment-emergent adverse events using standardized criteria. Researchers will monitor participants closely during treatment and through study completion, which includes a 28-day dose-limiting toxicity period. Participants will also provide tumor tissue samples before and possibly during treatment to help evaluate the therapys effects. The total duration depends on individual treatment response and continuation until progression or withdrawal.

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas