Actively Recruiting
Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer
Led by Zhejiang Doer Biologics Co., Ltd. · Updated on 2026-01-13
186
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label phase Ib/IIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.
CONDITIONS
Official Title
Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Between 18 and 75 years old.
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
- For colorectal cancer: confirmed unresectable locally advanced or metastatic disease; either no prior systemic chemotherapy (except specific cases) or progression after first-line chemotherapy.
- For other gastrointestinal tumors: confirmed unresectable locally advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma, HER2-negative or low; no prior systemic chemotherapy or progression more than 6 months after prior curative treatment.
- At least one measurable lesion per RECIST v1.1.
- Adequate bone marrow, liver, and kidney function.
- Agreement to use effective contraception during the study and for 180 days after last medication if of reproductive potential.
- Ability to understand and comply with study visits, treatments, and tests.
You will not qualify if you...
- Presence of MSI-H or dMMR.
- History of severe allergic reactions to monoclonal or bispecific antibodies or known allergies to study drugs.
- Use of high-dose corticosteroids or immunosuppressants within 14 days before first dose.
- Receipt of live attenuated vaccines, systemic or local anti-tumor treatments within specified timeframes before study start.
- Local radiotherapy within 2 months before first dose (except certain palliative cases).
- Use of nonspecific immunomodulatory therapy within 2 weeks before first dose.
- Participation in other investigational drug/device studies within 28 days before first dose.
- Major surgery or severe trauma within 28 days before first dose or expected during study.
- Severe infections within 28 days before first dose or recent systemic antibiotic use (except prophylactic).
- Persistent significant toxicities from prior treatments.
- Presence of central nervous system metastases or cancerous meningitis, with specific conditions for brain metastases.
- Active infections including hepatitis B, hepatitis C, HIV, syphilis, or tuberculosis.
- Significant cardiovascular or cerebrovascular diseases within 6 months before first dose.
- Active autoimmune diseases requiring systemic treatment within 2 years before first dose.
- History of other malignancies within 3 years except certain cured cancers.
- Severe or uncontrolled medical conditions affecting safety or compliance.
- History of allogeneic stem cell or solid organ transplantation.
- History of substance abuse or mental disorders affecting study compliance.
- Pregnant or breastfeeding women.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yulong Gan Clinical Operations Director
CONTACT
Y
Yongliang Fang 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
3
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