DCSZ11 Monotherapy and Combination for Advanced Solid Tumors

This study is testing a new drug called DCSZ11, both by itself and in combination with other approved cancer treatments like pembrolizumab, doxorubicin, or tebentafusp. It's for people with advanced or metastatic (spread throughout the body) solid tumors that have progressed after standard treatments. Researchers want to see how safe DCSZ11 is, what side effects it might cause, and if it can shrink tumors. They will also look at how your body handles the drug. To join, you must be at least 18 years old and have a solid tumor that has progressed after prior therapy. The study is currently recruiting up to 320 participants, but its overall status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves two main parts: a dose escalation phase (Phase 1a) to find the right dose, and a dose expansion/optimization phase (Phase 1b) to further study safety and effectiveness. Up to 320 participants are planned.
What's involved
You will receive DCSZ11 as a single intravenous (IV) infusion on Day 1 of each 21-day cycle. The study will also involve assessments for side effects and tumor response.
Compensation
Not stated in the trial record.
Follow-up
The frequency and severity of side effects will be monitored for up to 3 years. Tumor response will be assessed for 1 year.

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NCT05785754

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
DynamiCure Biotechnology
~320 participants
Updated 2025-06-26 on ClinicalTrials.gov
What's tested:DCSZ11PembrolizumabDoxorubicinTebentafusp

At a glance

Recruiting sites
29 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Incidence of dose limiting toxicites (DLTs)
Measured over 21 days
+2 more outcomes measured
Advanced or Metastatic Solid Tumors
35 sites across 19 states
South Korea5
Australia4
Taiwan4
Arizona2
Colorado2
Florida2
New South Wales2
South Australia2

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  • Phase 1a: Incidence of dose limiting toxicites (DLTs)21 days
  • Phase 1a: Frequency and severity of treatment emergent adverse eventsup to 3 years
  • Phase 1b: Overall response rate (ORR) per Investigator-assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)1 year