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Monoclonal Antibodies
SIM0237 for Solid Tumors
New York, NY
Phase 1
Waitlist Available
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
No Placebo-Only Group
Summary
This trial studies if a drug (SIM0237) is safe and effective to treat advanced solid tumors.
See full description
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Closest Location:Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN· 168 miles
Who is running the clinical trial?
Shanghai Xianxiang Medical Technology Co., Ltd.Industry Sponsor
6 Previous Clinical Trials
1,181 Total Patients Enrolled
Jiangsu Simcere Pharmaceutical Co., Ltd.Lead Sponsor
74 Previous Clinical Trials
15,556 Total Patients Enrolled
Simcere ZaimingUNKNOWN
Bijoyesh Mookerjee, MDStudy ChairSimcere Zaiming
4 Previous Clinical Trials
179 Total Patients Enrolled
Media Library
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.