Actively Recruiting
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
Led by DynamiCure Biotechnology · Updated on 2025-06-26
320
Participants Needed
35
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Expansion/Optimization). 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.
CONDITIONS
Brief Title
DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Able and willing to provide written informed consent
- Histologically or cytologically confirmed advanced (metastatic or unresectable) solid tumor that progressed after at least one prior therapy or has no effective standard therapy
- Patients with glioblastoma or CNS tumors may participate if corticosteroid use is stable or not required
- Phase 1b patients must have specific tumor types per protocol, including non-squamous NSCLC, microsatellite stable colorectal cancer, soft tissue sarcoma, or uveal melanoma, meeting additional criteria
- At least one measurable lesion by RECIST 1.1 criteria, except specified exceptions
- Stable treated CNS metastases allowed under certain conditions
- ECOG performance status 0 to 2 (0 or 1 for expansion cohorts)
- Adequate organ function and bone marrow reserve per laboratory assessments
- Recovery from prior treatment toxicities to Grade 1 or baseline
- Patients with HIV must have well-controlled disease and meet specified criteria
- Female patients must use effective contraception or be postmenopausal/surgically sterile
- Male patients must agree to use effective contraception or abstinence
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Received systemic anticancer treatments or investigational products within 28 days or 5 half-lives before study drug
- Recent radiotherapy or radiation-related toxicities requiring corticosteroids
- Second malignancy within 3 years except certain treated cancers
- Active CNS metastases or carcinomatous meningitis
- Recent arterial or venous thrombotic events
- Left ventricular ejection fraction below 50%
- Recent major or minor surgery with ongoing complications
- Marked proteinuria or nephrotic syndrome
- Known allergies to study drugs or imaging agents
- Prior severe immune-related adverse events or hypersensitivity to pembrolizumab for combination groups
- Autoimmune disease requiring recent immunosuppressive therapy
- Immunodeficiency or recent high-dose steroid use
- History of lung radiation over dose limits or pneumonitis/interstitial lung disease
- History of organ transplant
- Recent live vaccine administration
- Active infection requiring systemic therapy
- Active hepatitis B or C infection
- Serious cardiac conditions within 6 months
- Conditions or circumstances that impair consent or study cooperation
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several 21-day cycles during the dose escalation phase
Participants receive initial dose escalation of DCSZ11 as monotherapy or in combination with pembrolizumab to assess safety and determine dosage.
Repeated visits every 3 weeks for dosing and assessments
Duration - Ongoing 21-day cycles during dose expansion and optimization phases
Participants receive DCSZ11 intravenously every 3 weeks either as monotherapy or in combination with pembrolizumab or other standard-of-care drugs depending on their cohort, to evaluate safety, tolerability, and antitumor activity.
Visits every 3 weeks for dosing and monitoring
Duration - Up to 3 years
Participants are monitored for long-term safety, treatment response, and survival outcomes after treatment ends.
Periodic visits for follow-up assessments over several years
Trial Site Locations
Total: 35 locations
1
University of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Sarah Cannon Research Institute Denver Healthone
Denver, Colorado, United States, 80218
Actively Recruiting
6
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
7
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
9
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
10
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Completed
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
MonteFiore
The Bronx, New York, United States, 10461
Actively Recruiting
13
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
14
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Actively Recruiting
16
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
17
University of Sunshine Coast
Buderim, Queensland, Australia, 4556
Withdrawn
18
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
19
The Queen Elizabeth Hospital (TQEH)
Woodville South, South Australia, Australia, 5011
Actively Recruiting
20
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
21
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Completed
22
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
23
Townsville Hospital
Douglas, Australia, QLD4810
Actively Recruiting
24
Liverpool Hospital
Liverpool, Australia, NSW2170
Completed
25
Mater Misericordiae Health Services Brisbane Ltd
South Brisbane, Australia, QLD4101
Actively Recruiting
26
Sydney Adventist Hospital
Wahroonga, Australia
Withdrawn
27
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
28
Dong-a University Hospital
Busan, South Korea, 49201
Actively Recruiting
29
Cha University Bundang Medical Center
Gyeonggi-do, South Korea, 13496
Actively Recruiting
30
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
31
Asan Medical Center
Seoul, South Korea
Withdrawn
32
Kaohsiung Medical University Chung-ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
33
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
34
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
35
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
S
Sr Medical Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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