An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors

NCT06076291 | Active Not Recruiting Phase 1

• 1 other identifier: CSG-1827-101
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG1827 in subjects with Advanced Solid Tumors, refractory or resistant to standard therapy, or without available standard or curative therapy.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

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

  Through study completion, an average of one year

• MTD/MAD/ RP2D

  MTD/MAD/RP2D will be determined based on the DLTs and safety data.

  Through study completion, an average of one year

Secondary Outcomes (5)

• 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

• PD endpoints: cytokine levels

  Through study completion, an average of one year

• Immunogenicity endpoints:

  Through study completion, an average of one year

• Efficacy endpoints:

  Through study completion, an average of one year

Study Arms (1)

SG1827

EXPERIMENTAL

SG1827 monotherapy intravenous (IV) infusion - administered every three weeks (Q3W)

Drug: SG1827

Interventions

SG1827 DRUG

PhaseⅠa will use an accelerated titration and Bayesian optimal interval (AT-BOIN) design with 7 dose cohorts: 0.02mg/kg, 0.2mg/kg, 1mg/kg, 3mg/kg, 6mg/kg, 10mg/kg, and 15mg/kg by IV infusion. Accelerated titration (1 patient) will be only applied to the first cohort.

SG1827

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign the informed consent form (ICF).
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy ≥3 months.
• Histologically or cytologically documented advanced or metastatic solid tumors that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available. In the dose-expansion cohorts (Phase 1b), histologically or cytologically confirmed selected advanced solid tumors.
• Subject must have at least one measurable lesion according to RECIST Version1.1.
• Adequate organ function.
• Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0).
• 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 treatment and for at least 5 months (150 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test within 7 days prior to dosing and must not be lactating.
• Male patients must refrain from donating sperm from the time the ICF is signed until at least 5 months after the last dose.

You may not qualify if:

• Subjects with symptomatic central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Except the subjects who have been treated, be asymptomatic.
• 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).
• Have received any of the following treatments or procedures:
• Prior treatment with any antitumor therapy targeting CTLA-4.
• Subjects received open surgery within 28 days prior to the first dose (except for surgeries for the purpose of biopsy).
• Subjects received systemic anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, immunotherapy and other experimental drugs) within 28 days or 5 drug half-lives (which occurs first) prior to the first dose, and all AEs have not returned to grade ≤1 (CTCAE 5.0).
• Subjects received curative radiotherapy within 28 days prior to the first dose; palliative radiotherapy is allowed if which occurs within 14 days prior to the first dose, and all AEs have not returned to grade ≤1 (CTCAE 5.0).
• Any live vaccine within 28 days prior to the first dose.
• Prior allogeneic organ grafting or allogeneic stem cell transplantation.
• Subjects received systemic corticosteroids (equivalent dose \> 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose or will receive during the study. Except topical or prophylactic treatment for non-autoimmune diseases.
• Presence of active infection requiring antibiotic therapy within 30 days prior to the first dose, except for prophylaxis use.
• 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 , including myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass, etc.
• QTcF \>450 ms (corrected QT interval with Fridericia formula); history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twist ventricular tachycardia); history or family history of congenital long QT syndrome; arrhythmias requiring antiarrhythmic drug therapy (patients with atrial fibrillation with controllable heart rate 1 month prior to the first dose of the investigational drug may be enrolled).

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (6)

The Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Henan Cancer Hospital

Zhenzhou, Henan, 450003, China

Location

The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, 410013, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

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: September 24, 2023
• First Posted: October 10, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)