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Monoclonal Antibodies
SIM0237 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study Summary
This trial studies if a drug (SIM0237) is safe and effective to treat advanced solid tumors.
Who is the study for?
Adults over 18 with advanced solid tumors that can't be removed by surgery or treated locally, who haven't benefited from standard treatments or can't receive them. They should have a life expectancy of at least 12 weeks, a performance status score of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature, and measurable cancer according to specific criteria. Women must test negative for pregnancy and agree to contraception; men also need to use contraception.Check my eligibility
What is being tested?
The trial is testing SIM0237's safety and effectiveness on patients with advanced solid tumors. It's an early-phase study (phase I) where researchers will observe how the drug behaves in the body (pharmacokinetics), its effects on the tumor (pharmacodynamics), side effects, and preliminary signs if it works against cancer.See study design
What are the potential side effects?
Since this is an early phase trial for SIM0237, exact side effects aren’t listed but may include typical reactions seen with other monoclonal antibodies such as allergic reactions, fatigue, nausea, fever, rash or potential organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation (Part One): Incidence and nature of Dose-Limiting Toxicity (DLT)
Dose Escalation (Part One): Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
+1 moreSecondary outcome measures
Dose Escalation (Part One): Objective Response Rate (ORR)
Dose Escalation and Expansion: Assessment of SIM0237 AUC
Dose Escalation and Expansion: Assessment of SIM0237 Cmax
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Experimental: PART TWO- Dose expansionExperimental Treatment1 Intervention
Patients will be administered a recommended dose of SIM0237 established from the Dose Escalation Phase of the study.
Group II: Experimental: PART ONE- Dose escalationExperimental Treatment1 Intervention
The purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of SIM0237 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period.
Find a Location
Who is running the clinical trial?
Jiangsu Simcere Pharmaceutical Co., Ltd.Lead Sponsor
68 Previous Clinical Trials
14,666 Total Patients Enrolled
Shanghai Xianxiang Medical Technology Co., Ltd.UNKNOWN
4 Previous Clinical Trials
835 Total Patients Enrolled
Simcere ZaimingUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced cancer cannot be removed by surgery and doesn't respond to standard treatments.I am not on any other cancer treatments or high-dose steroids.I am 18 years old or older.I haven't had major heart issues or uncontrolled high blood pressure in the last 6 months.I have brain metastases needing treatment or have been on steroids for them within the last 2 weeks.I haven't had any infections needing IV treatment in the last 2 weeks.I have active hepatitis B or C and am receiving or will receive antiviral treatment.My heart, lungs, and kidneys are functioning well.I am not pregnant and agree to use birth control or abstain from sex during the study.I have had lung inflammation or severe lung disease treated with steroids.I have not had major surgery within the last 2 weeks.I am fully active or can carry out light work.I agree to use contraception for 6 months after my last treatment dose.I haven't had any cancer besides localized ones considered cured in the last 2 years.I haven't had active tuberculosis in the past year.I have not received any live vaccines in the last 4 weeks.I have been treated with IL-15 agonists before.I have had diverticulitis or peptic ulcer disease in the last 2 years.I still have side effects from cancer treatment that haven't improved.I have fluid buildup needing drainage or HIV/AIDS.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: PART ONE- Dose escalation
- Group 2: Experimental: PART TWO- Dose expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for enrolment in this clinical trial?
"The most up-to-date information from clinicaltrials.gov shows that this medical trial is recruiting patients; it was initially posted on March 8th 2023 and edited for the last time on March 10th 2023."
Answered by AI
To what extent is participation in this clinical trial being sought?
"The sponsor, Jiangsu Simcere Pharmaceutical Co., Ltd., will be running this clinical study at various medical centres including NYU Langone in New york and University of Texas MD Anderson Cancer Center in Houston. In order to successfully conduct the trial, 192 patients that meet inclusion criteria must be recruited."
Answered by AI
Has the FDA sanctioned Experimental: PART ONE- Dose escalation?
"As this study is still in its initial phase, the safety rating for Experimental: PART ONE- Dose escalation was determined to be 1 due to limited data showing both efficacy and security."
Answered by AI
What outcomes is this research aiming to evaluate?
"This trial aims to gauge the proportion of participants who experience treatment-emergent adverse events (TEAEs) over an 18 month period. Secondary endpoints being evaluated are dose interruption and delay rates, peak drug concentration in the blood stream (Cmax), and total amount of exposure calculated through area under curve analysis (AUC)."
Answered by AI
To what extent is this experiment being conducted in clinical facilities?
"Currently, 8 sites are actively running this trial. Locations span New york, Houston and Fuzhou as well as half a dozen other places. To reduce travel necessitated by the study's requirements, participants should select the closest centre to their home."
Answered by AI
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