Trial Title:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants With Advanced Solid Tumors
NCT ID:
NCT05781360
Condition:
Locally Advanced Unresectable or Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SIM0237
Description:
SIM0237 should be administered intravenously at recommended dose qw or other dosing
regimens
Arm group label:
Experimental: PART ONE- Dose escalation
Arm group label:
Experimental: PART TWO- Dose expansion
Summary:
This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and
pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with
advanced solid tumors.
Detailed description:
The study starts with a dose escalation part (Part 1) followed by a dose expansion part
(Part 2). The main purpose of this study is to evaluate the safety and tolerability of
SIM0237 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended
dose(s) (RD) and preliminary anti-tumor activity when given once every week or other
dosing regimens. Additional purposes of the study are to evaluate the pharmacokinetics
(PK) properties, immunogenicity, correlation of the biomarkers and PK profile with
anti-tumor activity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent;
- ≥18 years of age;
- Histological/cytological diagnosis of selected locally advanced unresectable or
metastatic solid tumor not amenable to local therapies (clinical diagnosis of HCC is
allowed); participants must have failed to derive clinical benefit on standard
therapies, or ineligible for the standard of care therapy
- Presence of at least one measurable lesion according to RECIST Version 1.1
- ECOG performance status score of 0 or 1;
- Life expectancy of ≥12 weeks;
- Participant must have adequate main organ function.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 72 hours prior to the start of study treatment. WOCBP must be willing to use
either 2 adequate barrier methods or a barrier method plus a hormonal method of
contraception to prevent pregnancy or to abstain from heterosexual activity
throughout the study, starting from the first dose of the study treatment through
180 days after the last dose of study treatment.
- Male participants must agree to use adequate contraception starting from the first
dose of the study treatment through 180 days after the last dose of the study
treatment.
Exclusion Criteria:
- Within the defined washout periods for prior anti-cancer treatments;
- Participant is currently participating or has participated in a study of an
investigational agent or using an investigational device within 4 weeks of first
dose of SIM0237.
- Any other malignancy within 2 years prior to the first dose of the study treatment
except for localized cancers that are considered to have been cured and in the
opinion of the Investigator present a low risk for recurrence.
- Participant has not recovered (i.e., to Grade 1 or to baseline) from previous
anticancer therapy-induced AEs.
- Participants with a history of recently (within previous 2 years of the first dose
of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;
- Major surgery within 2 weeks of receiving the first dose of study treatment;
- Participant has symptomatic central nervous system (CNS) metastases, or CNS
metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or
corticosteroids therapy within 2 weeks of first dose of study treatment;
- Participants with a history of active pulmonary tuberculosis infection within 1
year; participants with history more than 1 year prior to the first dose of study
treatment may be considered suitable if there is no evidence of active pulmonary
tuberculosis judged by the Investigator;
- Participants with clinically significant cardiovascular diseases, in the past 6
months prior to the first dose of the study treatment; symptomatic coronary heart
disease requiring drug treatment; arrhythmia requiring drug treatment; QTcF interval
>480 msec; or uncontrolled hypertension;
- Participants who have ascites requiring drainage or pleural effusion or pericardial
effusion requiring drainage within 28 days after previous drainage; Known human
immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome
(AIDS);
- Active or chronic hepatitis B or hepatitis C infection; participant with HBsAg
positive or detective HBV-DNA at screening should receive antiviral treatment as per
local practice during the study.
- Concomitant therapy with any other anti-cancer therapy or chronic use of
immunosuppressive doses (more than 10 mg/day of prednisone or equivalent) of
systemic corticosteroids.
- Active known or suspected autoimmune disease.
- History of non-infectious pneumonitis that has required a course of oral or
intravenous steroids to assist with recovery, or interstitial lung disease or severe
obstructive pulmonary disease;
- History of severe hypersensitivity reactions to mAbs;
- History of allogeneic organ transplantation or graft-versus-host disease;
- Use of any live vaccine therapy within 4 weeks prior to the first dose of study
treatment;
- Any active infection requires systemic treatment via intravenous infusion within 2
weeks prior to the first dose of study treatment;
- Known psychiatric disorder or drug abuse that would interfere the trial
requirements;
- Previous treatment with IL-15 agonists;
- Participant is pregnant or breastfeeding, or expecting to conceive or father
children within the projected duration of the study.
- Other conditions that researchers consider inappropriate for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rohan Maniar, MD
Facility:
Name:
NYU Langone
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Salman Punekar, MD
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarina Piha-Paul, MD
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230061
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinhua Han, MD
Contact backup:
Last name:
Aizong Shen, MD
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingfeng Liu, MD
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiming Wang, MD
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Wang, MD
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuping Sun, MD
Contact backup:
Last name:
Xue Meng, MD
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianzhong Shentu, MD
Contact backup:
Last name:
Weijia Fang, MD
Start date:
March 8, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Xianxiang Medical Technology Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Simcere Zaiming
Agency class:
Other
Source:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781360
