Actively Recruiting
DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
Led by West China Hospital · Updated on 2026-03-11
9
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.
CONDITIONS
Official Title
DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Able and willing to provide written informed consent
- Histologically confirmed advanced or metastatic solid tumors eligible for guideline-based chemotherapy and immunotherapy
- Patients with recurrent or metastatic head and neck squamous cell carcinoma must have PD-L1 Combined Positive Score (CPS) of 1 or higher
- Lung cancer patients with actionable driver mutations are excluded
- Prior adjuvant or neoadjuvant chemotherapy allowed if at least 6 months have passed since last treatment and disease recurrence is documented
- Gastric cancer patients must be HER2-negative
- At least one measurable lesion per RECIST 1.1 criteria
- Patients with treated CNS metastases must have stable disease for at least 4 weeks, neurological symptoms resolved, and no steroid use for at least 14 days prior to first dose
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function within 10 days prior to first dose
- PD-L1 status available via approved assay
- Resolution of prior treatment toxicities to Grade 1 or baseline, except some allowed neuropathy, hearing loss, alopecia, or stable autoimmune endocrinopathies
- Female patients must agree to contraception or abstinence requirements and not breastfeed for 5 months after last dose
- Male patients must agree to contraception or abstinence requirements
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Systemic anticancer or investigational therapy within 6 months prior to first dose (except low-dose corticosteroids and certain bone therapies)
- Extensive radiotherapy within 6 months before treatment or unresolved radiotherapy toxicity requiring corticosteroids
- Second primary malignancy within 3 years, except certain treated skin, prostate, cervical, breast, or colorectal conditions
- Known active CNS metastases or carcinomatous meningitis
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose without full recovery
- Known hypersensitivity to study drugs
- Prior immunotherapy discontinued due to severe immune-related adverse events
- Active autoimmune disease requiring systemic immunosuppression within 2 years, except stable hormone replacement
- Immunodeficiency or recent use of systemic steroids or immunosuppressants
- History of significant lung radiation or pneumonitis/ILD requiring steroids
- History of allogeneic tissue or organ transplantation
- Live or live-attenuated vaccines within 4 weeks before treatment
- Active infection needing systemic therapy
- Positive hepatitis B surface antigen with detectable DNA
- Hepatitis C infection with detectable RNA at screening
- Recent serious cardiovascular conditions within 6 months prior to first dose
- Any condition compromising consent, study compliance, or safety
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sichuan University West China Hospital, Chengdu, Sichuan
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
CONTACT
Z
Ziyu Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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