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SG1906 for CLDN18.2-Positive Solid Tumors

NCT05857332 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

DRUG

SG1906

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.

Sponsors & Collaborators

  • Hangzhou Sumgen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2027-02-28
Completion
2027-08-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857332 on ClinicalTrials.gov