Actively Recruiting
SG1906 for CLDN18.2-Positive Solid Tumors
Led by Hangzhou Sumgen Biotech Co., Ltd. · Updated on 2025-06-25
60
Participants Needed
9
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.
CONDITIONS
Official Title
SG1906 for CLDN18.2-Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Expected survival time of at least 3 months.
- Able to provide tumor tissue samples for CLDN18.2 testing.
- Phase Ia: Patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors who have relapsed after, failed, are intolerant to, ineligible for, or refuse standard therapy.
- Phase Ib: Patients with CLDN18.2-positive locally advanced unresectable or metastatic gastric, gastroesophageal junction adenocarcinoma, or pancreatic cancer who have failed, relapsed after, or are intolerant to standard therapy.
- At least one evaluable lesion according to RECIST 1.1.
- Adequate bone marrow function: neutrophils ≥1.5 x 10⁹/L, platelets ≥100 x 10⁹/L, hemoglobin ≥10.0 g/dL without recent supportive treatment.
- Adequate liver function: serum total bilirubin ≤1.5 x ULN, AST and ALT ≤2.5 x ULN (≤5 x ULN with liver metastases), albumin ≥3.0 g/L.
- Adequate renal function: serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min.
- Coagulation within normal limits without anticoagulation therapy.
- Toxicity from prior anti-tumor therapy recovered to Grade 0-1 except certain controlled conditions.
- Women of childbearing potential and male partners must use approved contraception during and 6 months after treatment; women must have negative pregnancy test and not be breastfeeding.
- Male patients must not donate sperm during and 6 months after treatment.
You will not qualify if you...
- Active central nervous system metastases or spinal cord compression, except stable treated brain metastases or small asymptomatic brain metastases.
- Active autoimmune disease requiring systemic therapy within past 2 years.
- Pyloric obstruction or chronic nausea, persistent vomiting, or diarrhea.
- Recent gastrointestinal bleeding within 3 months without recovery.
- Active gastrointestinal diseases such as ulcers, pancreatitis, enteritis, megacolon, or Crohn's disease.
- Long-term use of NSAIDs or therapeutic anticoagulants.
- Presence of body fluid requiring treatment or drainage.
- Unintentional weight loss of 5% or more in 1 month despite nutritional support.
- History of hemolytic anemia or red blood cell disorders.
- Active infection needing antibiotics within 2 weeks prior to first dose.
- Recent significant cardiovascular disease or abnormalities.
- Uncontrolled hypertension.
- Active hepatitis B or C requiring treatment.
- Known HIV infection.
- History of severe hypersensitivity to biological products or SG1906 components.
- Prior treatment targeting CLDN18.2 or CD47.
- Recent open surgery within 3 months except biopsy.
- Recent systemic anticancer therapy or radiotherapy within defined timeframes.
- Recent live vaccine within 4 weeks.
- Recent use of growth factors or blood products for anemia or platelet count.
- Recent systemic corticosteroids or immunosuppressive drugs except specified exceptions.
- Any condition deemed unsuitable by the Investigator.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
2
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
3
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
5
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
6
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
7
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
8
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
9
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
P
Pengyu Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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