Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors
Led by Zhejiang Doer Biologics Co., Ltd. · Updated on 2026-04-27
216
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to characterize the safety,tolerability, pharmacokinetics(PK),and preliminary anti-tumor activity of DR30206, in subjects with advanced or metastatic solid tumors
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form
- Age between 18 and 75 years
- Part A: Patients with advanced or metastatic malignant solid tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no effective standard therapy
- Part B: Patients with locally advanced or metastatic non-small cell lung cancer without EGFR-sensitive mutations or ALK gene fusions, no prior systemic anti-tumor therapy for this stage, and tumor tissue samples available with PD-L1 TPS ≥1%
- Patients must have at least one evaluable lesion (Part A) or measurable lesion per RECIST v1.1 (Part B)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate bone marrow, liver, and renal function
- Male or female patients with fertility must agree to use effective contraception during and for 6 months after treatment
- Ability to understand and follow study procedures
You will not qualify if you...
- History of severe allergies to monoclonal or bispecific antibodies or components of the study drug
- Active malignant tumors within the past 2 years except locally cured tumors or study tumors
- Severe chronic or active infections within 4 weeks prior to treatment start
- Systemic antibiotic treatment within 2 weeks before study treatment
- Participation in interventional clinical studies, major surgery, or severe trauma within 4 weeks before treatment
- Live attenuated vaccine use expected during treatment or within 5 months after last dose
- Systemic anti-tumor or immune stimulator treatments within 4 weeks before treatment
- Radical radiotherapy within 3 months before treatment
- Systemic immunosuppressive medication within 4 weeks before treatment or expected during treatment
- Known active central nervous system metastasis
- Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to dosing
- Active or history of autoimmune disease or immune deficiency
- History or presence of certain lung diseases or active pneumonia
- Active or diagnosed inflammatory bowel disease
- Large or symptomatic pleural, pericardial, or abdominal effusions during screening
- Tumors with high bleeding risk as assessed by imaging
- History of gastrointestinal perforation, wound healing issues, or bleeding events
- Recent use of high-dose aspirin or certain platelet inhibitors
- Unstable use of full-dose anticoagulant or thrombolytic therapy
- Unresolved adverse reactions from prior treatments above CTCAE level 1
- Known active infection
- Prior allogeneic stem cell or organ transplantation
- History of transplantation requiring immunosuppressants
- Pregnant or lactating women
- Any other condition that could affect safety or study results as judged by the investigator
- Participants deemed inappropriate for the trial by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
S
Senior Clinical Operations Director
CONTACT
C
Chief Operating Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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