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New treatment option for Locally Advanced Unresectable or Metastatic Solid Tumors
Official title SG1906 for CLDN18.2-Positive Solid Tumors
ClinicalTrials.gov ID: NCT05857332
What this study is testing
What is SG1906?
SG1906 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced unresectable or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all the following criteria to be eligible for participation in this study:
- Understand and voluntarily sign the informed consent form (ICF).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Expected survival time of ≥3 months.
You likely can't join if
- Patients who meet any of the following criteria cannot be enrolled:
- Presence of active central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or...
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or...
- Pyloric obstruction or any other condition that can cause long-term chronic nausea, persistent recurrent vomiting (≥3 vomit episodes in 24 hours) or...
- Patients who have recently developed gastrointestinal bleeding (i.e., a history of hematemesis, hematochezia, or melena within the past 3 months)...
- Patients with active gastrointestinal disease including, but not limited to, gastric or duodenal ulcers, acute gastric or intestinal perforation...
See the full eligibility criteria
Who can join
- Patients must meet all the following criteria to be eligible for participation in this study:
- Understand and voluntarily sign the informed consent form (ICF).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Expected survival time of ≥3 months.
- Able to provide tumor tissue samples for CLDN18.2 detection.
- Specific requirements for patients enrolled in Phase Ia and Phase Ib are as follows: Phase Ia Dose Escalation Phase
- Patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to...
- CLDN18.2 positivity is defined as H score ≥1 by central laboratory immunohistochemistry. Phase Ib Dose Expansion Stage
- Patients with histologically or cytologically confirmed CLDN18.2-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma or pancreatic cancer who have failed to respond to standard therapy, have...
- CLDN18.2 positivity is defined as H score ≥40 by central laboratory immunohistochemistry.
- At least one evaluable lesion (refer to Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1]).
- Adequate function of vital organs, defined as follows:
- Bone marrow function (no transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medically supportive therapy within 7 days prior to the first dose): neutrophil count ≥1.5 × 109/L, platelet count...
- Adequate liver function, which must meet all of the following criteria:
- Serum total bilirubin ≤1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (AST and ALT ≤5 × ULN in patients with liver metastases).
- Albumin ≥3.0 g/L.
- Renal function: serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50 mL/min (Cockcroft-Gault formula).
- Coagulation: international normalized ratio ≤1.5 × ULN or prothrombin time ≤1.5 × ULN, activated partial thromboplastin time ≤1.5 × ULN without receiving anticoagulation therapy.
- Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders controlled with hormone replacement therapy.
- Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study...
- Male patients must refrain from donating sperm from the time the ICF is signed until at least 6 months after the last dose.
What rules you out
- Patients who meet any of the following criteria cannot be enrolled:
- Presence of active central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Exception: patients with previously treated brain metastases...
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressive medications); related replacement therapy is allowed (e.g...
- Pyloric obstruction or any other condition that can cause long-term chronic nausea, persistent recurrent vomiting (≥3 vomit episodes in 24 hours) or diarrhea.
- Patients who have recently developed gastrointestinal bleeding (i.e., a history of hematemesis, hematochezia, or melena within the past 3 months) without evidence of recovery confirmed by endoscopy or colonoscopy; or...
- Patients with active gastrointestinal disease including, but not limited to, gastric or duodenal ulcers, acute gastric or intestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital...
- Patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs); patients who are using anticoagulants such as heparin at therapeutic doses or vitamin K antagonists (except for prophylaxis).
- Presence of body fluid (hydrothorax, ascites, pericardial effusion, etc.) requiring local treatment or repeated drainage.
- Unintentional weight loss ≥5% within 1 month prior to initial dose, even with peripheral or central intravenous nutritional support.
- History of hemolytic anemia from any cause (including Evans syndrome).
- History of defects in red blood cell production, hemoglobin production, or metabolism, such as glucose-6-phosphate dehydrogenase deficiency, thalassemia, sickle cell disease, and hereditary spherocytosis.
- History of hemophagocytic lymphohistiocytosis.
- Presence of active infection requiring antibiotic therapy within 2 weeks prior to the first dose, except for prophylaxis.
- Presence of cardiovascular system disease within 6 months prior to screening that meets any of the following:
- Cardiac function: congestive heart failure of New York Heart Association (NYHA) class III or IV; left ventricular ejection fraction \<50%.
- Clinically significant cardiac disease or surgery within 6 months prior to the first dose of the investigational drug, including myocardial infarction, unstable angina pectoris, cerebrovascular accident...
- QTcF (corrected QT interval with Fridericia formula) \>450 ms in men and \>470 ms in women; history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation...
- History of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose.
- Hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg) that has not been effectively controlled after treatment with standardized antihypertensive medication.
- Patients with active hepatitis B or C. In case of positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) during the screening period, further hepatitis B virus (HBV) DNA titer testing...
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);
- Known history of Grade 3 to 4 hypersensitivity reactions to any biological product, history of life threatening hypersensitivity reactions, or known hypersensitivity to components of SG1906 drug product (Grade ≥3...
- Have received any of the following treatments or procedures:
- Prior treatment with any antitumor therapy targeting CLDN18.2 or CD47
- Patients who have undergone open surgery ≤3 months prior to the first dose (except for surgeries for the purpose of biopsy).
- Prior allogeneic organ grafting.
- Systemic anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy and immunotherapy) within 28 days or 5 drug half-lives (whichever is shorter) prior to the first dose of the investigational drug...
- Radiotherapy ≤14 days prior to the first dose of the investigational drug; palliative radiotherapy is allowed if it is completed within 2 weeks prior to the enrollment in the study and radiotherapy-related toxicity has...
- Any live vaccine within 4 weeks prior to the first dose of the investigational drug
- Have received treatment with various growth factors, blood transfusions or other blood products for anemia or decreased platelet count within 14 days prior to the first dose of the investigational drug.
- Have received systemic corticosteroids (at a dose equivalent to \>10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. The following are permitted:
- Topical or inhaled glucocorticoids in physiologic replacement doses are allowed
- The use of short-course (≤7 days) corticosteroids at physiologic replacement doses for the prevention or treatment of non-autoimmune diseases is allowed.
- Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Shenyang, Liaoning, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Shenyang, Liaoning, China; Taiyuan, Shanxi, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.