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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
DynamiCure Biotechnology
Study ID
NCT05785754
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCSZ11 — DRUG
    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.
  • Pembrolizumab — DRUG
    Pembrolizumab injection
  • Doxorubicin — DRUG
    1b SOC Cohort 1: Doxorubicin combination in soft tissue sarcoma
  • Tebentafusp — DRUG
    1b SOC Cohort 2: Tebentafusp combination in uveal melanoma

Study Details

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).

Key Dates

Start date
Jun 28, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Dose Escalation Monotherapy
    Dose escalation to investigate the safety and tolerability of DCSZ11.
  • Experimental: Phase 1a Dose Escalation Combination
    Dose escalation to investigate safety and tolerability, and determine DCSZ11 Phase 1b doses in combination with pembrolizumab.
  • Experimental: Phase 1b Dose Expansions
    Dose expansion to further investigate the safety, tolerability, and preliminary evidence of antitumor activity of the combination with pembrolizumab in select tumor indications.
  • Experimental: Phase 1b Standard of Care
    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. The following SOC combination expansion cohorts will be enrolled: * 1b SOC Cohort 1: Doxorubicin combination in soft tissue sarcoma * 1b SOC Cohort 2: Tebentafusp combination in uveal melanoma

Primary Outcome Measure

Phase 1a: Incidence of dose limiting toxicites (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
Mayo ClinicPhoenixArizona85054-
HonorHealthScottsdaleArizona85258-
University of ColoradoAuroraColorado80045-
Sarah Cannon Research Institute Denver HealthoneDenverColorado80218-
Yale Cancer CenterNew HavenConnecticut06519-
Mayo ClinicJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
John Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
MonteFioreThe BronxNew York10461-
Ohio State UniversityColumbusOhio43210-
SCRI Oncology PartnersNashvilleTennessee37203-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALMayo Clinic· Phoenix, AZHonorHealth· Scottsdale, AZUniversity of Colorado· Aurora, COSarah Cannon Research Institute Denver Healthone· Denver, COYale Cancer Center· New Haven, CT

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