Trial Title:
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
NCT ID:
NCT06076291
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SG1827
Description:
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.
Arm group label:
SG1827
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.
Detailed description:
After a screening period of up to 28 days for each study phase, qualified patients will
be enrolled to receive their assigned dose of SG1827, administered every three weeks
(Q3W), until disease progression, intolerable toxicity or others, whichever occurs first.
The study consists of a dose escalation phase (Phase 1a) to determine the maximum
tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for SG1827 as a single agent,
and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will
characterize treatment of SG1827 as a single agent at the MTD or RP2D.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign the informed consent form (ICF).
2. Age ≥18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
4. Life expectancy ≥3 months.
5. 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.
6. Subject must have at least one measurable lesion according to RECIST Version1.1.
7. Adequate organ function.
8. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0).
9. 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.
10. Male patients must refrain from donating sperm from the time the ICF is signed until
at least 5 months after the last dose.
Exclusion Criteria:
1. 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.
2. 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).
3. Have received any of the following treatments or procedures:
1. Prior treatment with any antitumor therapy targeting CTLA-4.
2. Subjects received open surgery within 28 days prior to the first dose (except
for surgeries for the purpose of biopsy).
3. 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).
4. 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).
5. Any live vaccine within 28 days prior to the first dose.
6. Prior allogeneic organ grafting or allogeneic stem cell transplantation.
4. 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.
5. Presence of active infection requiring antibiotic therapy within 30 days prior to
the first dose, except for prophylaxis use.
6. Presence of cardiovascular system disease within 6 months prior to screening that
meets any of the following:
1. Cardiac function: congestive heart failure of New York Heart Association (NYHA)
class III or IV; left ventricular ejection fraction <50%.
2. Clinically significant cardiac disease or surgery , including myocardial
infarction, unstable angina pectoris, coronary/peripheral artery bypass, etc.
3. 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).
4. History of arterial thrombosis, deep venous thrombosis and pulmonary embolism.
7. Hyperglycaemia or Hypertension that has not been effectively controlled after
standard treatment.
8. Patients with active hepatitis B or C, or HIV antibody positive.
9. 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.
10. History of interstitial lung disease or non-infectious pneumonitis except for those
induced by radiation therapies.
11. Presence of body fluid (hydrothorax, ascites, pericardial effusion, etc.) requiring
local treatment or repeated drainage.
12. Immune-related adverse effects leading to permanent discontinuation during previous
antineoplastic immunotherapy.
13. Subjects with unhealed wounds.
14. Subjects with high risk of bleeding.
15. Subjects with other malignant solid tumors (except for cured defined tumors) within
5 years prior to the first dose.
16. Any other condition that, in the opinion of the Investigator, may lead to
inappropriate participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of USTC
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinghua Han
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ning LI
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhenzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jufeng Wang
Facility:
Name:
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shanzhi Gu
Facility:
Name:
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongchang Zhang
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Funan LIU
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Weijia Fang
Start date:
September 27, 2023
Completion date:
March 28, 2025
Lead sponsor:
Agency:
Hangzhou Sumgen Biotech Co., Ltd.
Agency class:
Industry
Source:
Hangzhou Sumgen Biotech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06076291
