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TJ011133 for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by AbbVie
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 21 or 28 days, depending on study part
Awards & highlights

Study Summary

This trial will test the safety of TJ011133, a potential new cancer treatment, in patients with solid tumors or lymphoma.

Eligible Conditions
  • Lymphoma
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 or 28 days, depending on study part
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 or 28 days, depending on study part for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Dose Limiting Toxicities (DLT)
Incidence and Severity of Adverse Events
+1 more
Secondary outcome measures
Efficacy: Best Overall Response (BOR)
Efficacy: Duration Of Response (DOR)
Efficacy: Objective Response Rate (ORR)
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2 - Dose ExpansionExperimental Treatment3 Interventions
30 participants (with DLBCL or indolent lymphoma) in the TJ011133 combination therapy with rituximab expansion and 20 participants with solid tumors in the TJ011133 combination therapy with pembrolizumab expansion.
Group II: Part 1C - Combination therapy of TJ011133 with rituximabExperimental Treatment2 Interventions
TJ011133 will be administered Q1W, starting at 20 mg/kg, in combination with rituximab.
Group III: Part 1B - Combination therapy of TJ011133 with pembrolizumabExperimental Treatment2 Interventions
TJ011133 will be administered Q1W, starting at 20 mg/ kg, in combination with pembrolizumab.
Group IV: Part 1A - TJ011133 MonotherapyExperimental Treatment1 Intervention
TJ011133 alone will be administered at up to 7 dose levels (0.3, 1, 3, 10, 20, 30, 45 mg/kg) once weekly (Q1W) (the 0.3 mg/kg dose level cohort will be enrolled if a DLT in 1 out of 3 subjects is observed following the 1 mg/kg dose level).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TJ011133
2019
Completed Phase 2
~210
Pembrolizumab
2017
Completed Phase 2
~2010
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,946 Total Patients Enrolled
49 Trials studying Lymphoma
7,681 Patients Enrolled for Lymphoma
I-Mab Biopharma Co. Ltd.Industry Sponsor
21 Previous Clinical Trials
2,385 Total Patients Enrolled
Claire Xu, MD, PhDStudy DirectorI-Mab Biopharma
2 Previous Clinical Trials
181 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what quantity of U.S.-based healthcare facilities is the clinical experiment being conducted?

"This medical trial is being administered from Yale School of Medicine in New Haven, Connecticut; University of Alabama - Birmingham in Birmingham, Alabama; and Vanderbilt-Ingram Cancer Center /ID# 233975 in Rochester, Minnesota. Additionally, there are 25 other sites participating in this study."

Answered by AI

Has the Food and Drug Administration given TJ011133 regulatory clearance?

"TJ011133 has only gone through Phase 1 trials, so it was assigned a score of one in terms of safety. This reflects the limited data that is available regarding its efficacy and security."

Answered by AI

What is the ultimate aim of this clinical experimentation?

"The principal measure of impact for this AbbVie-sponsored study will be the Occurrence and Intensity of Adverse Reactions, observed over a period up to 100 days after their last dose. Additionally, Secondary Outcomes such as Maximum Observed Concentration (Cmax), Volume of Distribution at Steady State (Vss) and Trough Concentration (Ctrough) shall also be evaluated."

Answered by AI

How many individuals have registered for participation in this clinical experiment?

"At the present, this clinical trial is not accepting any more patients. Initially posted on April 16th 2019 and last updated August 22nd 2022, it has stopped recruiting participants. Nevertheless, there are many other studies requiring individuals with lymphoma - 2135 in total - as well as 1357 actively enrolling for TJ011133 specifically."

Answered by AI

Could you provide an overview of previous research studies conducted with TJ011133?

"TJ011133 was first investigated in 1993 at the NIH Clinical Centre, 9000 Rockville Pike. A total of 1053 studies have been concluded since then. As it stands, 1357 active investigations are underway, many taking place out of New Haven, Connecticut."

Answered by AI

Are the recruitment stages of this trial still open?

"At this juncture, recruitment for the aforementioned clinical trial has been suspended. Its first appearance online was on April 16th 2019 and it last underwent an edit on August 22nd 2022. If you are shopping around for other studies, there are presently 2135 trials involving lymphoma that still need more participants and 1357 studies actively recruiting patients for TJ011133."

Answered by AI

What maladies is TJ011133 commonly employed to alleviate?

"TJ011133 is a therapeutic agent that can be used to treat polyangium as well as malignant tumours, unresectable melanoma and microsatellite instability high conditions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma
2019. "Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03934814.
~16 spots leftby Apr 2025
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