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TJ210001 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by I-Mab Biopharma US Limited
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 up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, TJ210001, in patients with advanced solid tumors that have come back or resisted treatment. The drug is given regularly, and doses are adjusted to find the safest and most effective amount.
Eligible Conditions
- Solid Tumors
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and Severity of Adverse Events
Maximum Tolerated Dose
Secondary study objectives
Anti-drug Antibodies (ADA)
Pharmacokinetic Profile
Response Rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Level 4Experimental Treatment1 Intervention
15 mg/kg Q1W
Group II: Dose Level 3Experimental Treatment1 Intervention
10mg/kg Q1W
Group III: Dose Level 2Experimental Treatment1 Intervention
3 mg/kg Q1W
Group IV: Dose Level 1Experimental Treatment1 Intervention
1mg/kg Q1W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TJ210001
2020
Completed Phase 1
~20
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Who is running the clinical trial?
I-Mab Biopharma US LimitedLead Sponsor
9 Previous Clinical Trials
560 Total Patients Enrolled
I-Mab Biopharma Co. Ltd.Lead Sponsor
21 Previous Clinical Trials
2,495 Total Patients Enrolled
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