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TJ004309 for Ovarian Cancer

Phase 2
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 from pre-dose in day 1 of cycle 1 to post-dose in day 21 of cycle 1 (each cycle is 21 days)
Awards & highlights

Study Summary

This trial is testing a new drug combination to treat advanced or metastatic solid tumors.

Eligible Conditions
  • Ovarian Cancer
  • Head and Neck Cancers
  • Gastrointestinal Cancer
  • Non-Small Cell Lung Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose in day 1 of cycle 1 to post-dose in day 21 of cycle 1 (each cycle is 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose in day 1 of cycle 1 to post-dose in day 21 of cycle 1 (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) in each Tumor Type
Secondary outcome measures
Assessment of PK parameter: Cmax
Assessment of PK parameter: tmax
Disease control rate (DCR)
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TJ004309 and AtezolizumabExperimental Treatment1 Intervention
TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TJ004309
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

I-Mab Biopharma US LimitedLead Sponsor
1 Previous Clinical Trials

Frequently Asked Questions

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

What potential harms could arise from exposure to TJ004309?

"TJ004309's safety is rated a 2 as there have been some studies conducted to verify its security, yet no clinical data demonstrating the efficacy of this drug exists."

Answered by AI

What indications is TJ004309 commonly utilized to treat?

"TJ004309 is most commonly used for the treatment of small cell lung cancer, but it has also been effective at managing malignant neoplasms, non-small cell lung carcinoma and postoperative cases."

Answered by AI

How many research subjects are involved in this investigation?

"At present, this medical trial is not looking for patients. It was first published on November 2nd 2021 and updated lastly on the 14th of November 2022. If you seek alternate studies to join, 1997 clinical trials are currently seeking participants with gastrointestinal cancers while 352 are also enrolling individuals affected by TJ004309."

Answered by AI

Is this experimentation open to new participants?

"This investigation is no longer accepting participants, according to the information posted on clinicaltrials.gov. Initially published November 2nd 2021 and last edited November 14th 2022, this study has ceased recruitment of candidates; however, there are currently 2349 other medical studies actively looking for volunteers."

Answered by AI

Have other controlled trials studied the effects of TJ004309?

"SCRI Tennessee Oncology Chattanooga was the originating site of TJ004309's clinical trial in 2008. Currently, there are 352 trials utilizing this medication actively recruiting patients with 80 studies having already been completed. Durham, North carolina is a major hub for these active trials."

Answered by AI

Does this initiative represent a pioneering effort in the medical field?

"Currently, there are 352 clinical investigations of TJ004309 in motion across 74 nations and 1656 cities. Hoffmann-La Roche initiated the initial trial for this medication back in 2008 and it included 720 participants before achieving Phase 2 drug approval status. Subsequently, another 80 studies have transpired since that time."

Answered by AI

How many sites are administering this investigation?

"For this medical trial, there are 20 operating locations such as Duke Cancer Center in Durham, Illinois Cancer Specialists in Arlington Heights and Maryland Oncology Hematology in Rockville. Moreover, there are other sites available for patient participation."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
Innovative Clinical Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Apr 2025