NCT05785754

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

A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: DynamiCure Biotechnology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b).

Detailed description

DCSZ11 will be administered as monotherapy and in combination with pembrolizumab in patients with advanced-stage or metastatic solid tumors. The Escalation Phase will be followed by a Dose Expansion/Optimization Phase (Phase 1b) to further characterize safety, PK, pharmacodynamics, and evidence of antitumor activity of DCSZ11 in combination with pembrolizumab in select relapsed/refractory (R/R) solid tumors and, if desired, optimize the DCSZ11 dose. Phase 1a - Dose Escalation Phase 1a is a dose escalation study of DCSZ11 as monotherapy in Part 1 and in combination with pembrolizumab in Part 2. DCSZ11 dose levels may be escalated up to the maximum tolerated dose level or to the maximum planned dose level of 20mg/kg. Patients will receive DCSZ11 IV initially every 3 weeks. Phase 1b - Dose Expansion/Optimization in Select Indications Phase 1b will evaluate DCSZ11 in combination with pembrolizumab in select indications following a Simon two-stage like design that allows for dose optimization. Phase 1b - Standard-of-Care (SOC) Combinations Safety Lead-in/ Expansion in Select Indications A safety lead-in using the BOIN design followed by a Simon two-stage like design will be used to evaluate DCSZ11 in combination with standard of care in select indications. Patients will receive DCSZ11 IV at one of the dose escalation dose levels/schedule (or dose/schedule selected for optimization/expansion). Once the safety lead-in is completed, a Bayesian continuous toxicity monitoring will be used to monitor for unacceptable toxicity in expansions.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	DCSZ11	A monoclonal antibody that binds to CD93, DCSZ11 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
DRUG	Pembrolizumab	Pembrolizumab injection
DRUG	Doxorubicin	1b SOC Cohort 1: Doxorubicin combination in soft tissue sarcoma
DRUG	Tebentafusp	1b SOC Cohort 2: Tebentafusp combination in uveal melanoma

Timeline

• Start date: 2023-06-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-03-27
• Last updated: 2025-06-26

Locations

35 sites across 4 countries: United States, Australia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study