SG1906 for CLDN18.2-Positive Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Sumgen Biotech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 (e.g., surgery, radiation therapy) who are clinically stable for at least 4 weeks after treatment (calculated from the first dose of investigational drug) and have discontinued corticosteroids for ≥14 days prior to the administration of investigational drug; patients with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, brain metastases ≤1.5 cm in length, no significant edema around the 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., thyroid hormone, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency).
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 evidence of risk of gastric bleeding.
Trial design
Design model
Single group
Treatments tested in this trial
SG1906
DrugPhase 1a will use an accelerated titration-Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 9 mg/kg, and 12 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 2 cohorts.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: SG1906Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0
Time frame
Through study completion, an average of one year2
MTD/MAD/ RP2D
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG1906 in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG1906 given intravenously in patients with CLDN18.2-positive locally advanced unresectable or metastatic solid tumors.
Time frame
Through study completion, an average of one yearSecondary outcomes
1
Pharmacokinetics (PK): AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame
Through study completion, an average of one year2
Pharmacokinetics (PK): Cmax
Cmax to maximum drug concentration.
Time frame
Through study completion, an average of one year3
Pharmacokinetics (PK):limination half-life (T1/2)
limination half-life (T1/2) of the drug after administration.
Time frame
Through study completion, an average of one year4
receptor occupancy (RO)
receptor occupancy (RO) of CD47 on the surface of peripheral blood cells;
Time frame
Through study completion, an average of one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov