SG1906 for CLDN18.2-Positive Solid Tumors

NCT05857332 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CSG-1906-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief Summary

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

Locally Advanced Unresectable or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0

  Through study completion, an average of one year

• 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.

  Through study completion, an average of one year

Secondary Outcomes (6)

• Pharmacokinetics (PK): AUC

  Through study completion, an average of one year

• Pharmacokinetics (PK): Cmax

  Through study completion, an average of one year

• Pharmacokinetics (PK):limination half-life (T1/2)

  Through study completion, an average of one year

• receptor occupancy (RO)

  Through study completion, an average of one year

• Immunogenicity endpoints:

  Through study completion, an average of one year

Study Arms (1)

SG1906

EXPERIMENTAL

SG1906 monotherapy intravenous (IV) infusion - Biweekly doses

Drug: SG1906

Interventions

SG1906 DRUG

Phase 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.

SG1906

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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 standard therapy, are not eligible for standard therapy, or refuse standard therapy.
• 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 relapsed after standard therapy, or are intolerant to standard therapy.
• 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:

You may not qualify 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 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.
• 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 megacolon or Crohn's disease.
• 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%.

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (9)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian, China

RECRUITING

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110801, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Pengyu Shi

CONTACT

+86 010 56315401; shipengyu@sumgenbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 12, 2023
• Study Start: May 30, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)