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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDynamiCure Biotechnology

About this trial

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).

Eligibility criteria

Qualifiers

Male or female patients ≥ 18 years of age.

Be willing and able to provide written informed consent for the study.

Patients in Phase 1a must have a histologically or cytologically documented, advanced (metastatic and/or unresectable) solid tumor that has progressed on or after standard therapy (relapsed/refractory patients; patients must have failed at least one prior line of therapy) or for whom there is no effective standard therapy based on the Investigator's judgment.

Non-squamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed and that has progressed to no more than 2 prior systemic therapies. Patients must not have presented with disease progression during the first 3 months of treatment with first line anti-PD-(1/L1)-containing therapy. Patients must have had documented disease progression per RECIST 1.1 within 12 weeks from the last dose of anti-PD-1/L1 mAb to be considered to have failed an anti-PD-(1/L1) mAb containing therapy. The initial evidence of disease progression to anti-PD-1/L1 mAb containing therapy needs to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • DCSZ11
  • Pembrolizumab
  • Doxorubicin
  • Tebentafusp

Treatment groups

320 Participants
are divided into 4 treatment groups

Locations

35
Australia
Scientia Clinical Research2031, RandwickNew South Wales, Australia
St Vincent's Hospital2010, SydneyNew South Wales, Australia
University of Sunshine Coast4556, BuderimQueensland, Australia
Southern Oncology Clinical Research Unit (SOCRU)5042, Bedford ParkSouth Australia, Australia

Sponsors and collaborators

DynamiCure Biotechnology

Lead sponsor