Phase 1 Study of DCSZ11 Alone and With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors Evaluating Safety, Dosage, and Early Effects

What this Trial Is About

Researchers are evaluating DCSZ11, a monoclonal antibody, as a treatment for patients with advanced or metastatic solid tumors. This Phase 1, multicenter, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential antitumor activity of DCSZ11 both alone and in combination with pembrolizumab. The study includes patients who have relapsed or refractory tumors and have limited or no effective standard therapy options. The study has two main phases Phase 1a Dose Escalation and Phase 1b Dose ExpansionOptimization. In Phase 1a, patients receive intravenous infusions of DCSZ11 every 3 weeks either as monotherapy or combined with pembrolizumab, with doses increased to find the maximum tolerated or planned dose. Phase 1b evaluates DCSZ11 combined with pembrolizumab or standard-of-care treatments like doxorubicin for soft tissue sarcoma and tebentafusp for uveal melanoma, using designs to optimize dosing and monitor safety continuously. Participants will undergo screening that includes biopsies, imaging, and laboratory tests to confirm eligibility and monitor response. Researchers will evaluate tumor response using established criteria such as RECIST and iRECIST over one year, and follow safety and survival outcomes for up to three years. The study involves regular clinic visits, safety assessments, and monitoring for immune responses and drug levels to understand treatment effects and tolerability.

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors