Actively Recruiting
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
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Willing and able to provide written informed consent
- Patients in Phase 1a must have advanced (metastatic or unresectable) solid tumors that progressed after standard therapy or have no effective standard therapy
- Patients in Phase 1b must have specific relapsed/refractory solid tumors including non-squamous NSCLC, microsatellite stable colorectal cancer failing prior therapies, or certain soft tissue sarcomas or uveal melanoma eligible for combination treatments
- Must have a lesion suitable for biopsy and at least one measurable lesion per RECIST 1.1, with exceptions for some patients
- Patients with treated and stable CNS metastases may participate under specified conditions
- ECOG performance status 0 to 2 (0 or 1 for expansion cohorts)
- Adequate organ function and bone marrow reserve based on laboratory tests within 10 days before first dose
- Recovery to Grade 1 or baseline from prior therapy toxicities
- Meet established criteria for standard-of-care agents if receiving combination treatment
- HIV-positive patients must have well-controlled disease on stable antiretroviral therapy
- Female patients must agree to contraception or abstinence during and after treatment
- Male patients must agree to effective barrier contraception or abstinence during and after treatment
- Willing and able to comply with clinic visits and study procedures
You will not qualify if you...
- Received systemic anticancer treatment or investigational agents within 28 days before first dose
- Received extended field radiotherapy within 4 weeks or have radiation-related toxicities requiring corticosteroids
- Have a second malignancy within 3 years except certain treated or non-active cancers
- Known active CNS metastases or carcinomatous meningitis
- Recent arterial thrombotic or embolic events within 3 months
- Recent venous thrombotic or pulmonary embolism events within 1 month unless stable on anticoagulation
- Left ventricular ejection fraction less than 50%
- Major surgery within 4 weeks or minor surgery within 2 weeks before first dose with unresolved complications
- Marked proteinuria or nephrotic syndrome
- Allergy or hypersensitivity to study drugs or imaging agents
- Prior severe immune-related adverse events or hypersensitivity related to pembrolizumab
- Autoimmune disease requiring immunosuppressive therapy within 2 years
- Immunodeficiency or recent systemic steroid/immunosuppressive therapy
- History of lung radiation >30 Gy within 6 months
- History or current pneumonitis or interstitial lung disease requiring steroids
- History of allogeneic tissue or solid organ transplant
- Received live vaccines within 4 weeks before treatment
- Active infection requiring systemic therapy
- Hepatitis B or C infection without appropriate control or treatment
- Serious cardiac conditions or events within 6 months
- Any condition or circumstance that may impair consent or study participation
- Pregnant or breastfeeding females
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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