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TJ033721 for Cancer

Phase 1

Recruiting

Research Sponsored by I-Mab Biopharma Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay

Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days post last dose

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating advanced or metastatic solid tumors.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including stomach and esophageal cancers, who have no standard treatment options left. They must be relatively healthy (ECOG status 0 or 1), have CLDN18.2-positive tumor expression, known PD-L1 status, and adequate organ function.Check my eligibility

What is being tested?

The study tests TJ033721's safety and effectiveness in patients with specific types of cancer. It's an early-phase trial where everyone gets the drug to see how well it works and what dose is best.See study design

What are the potential side effects?

Possible side effects aren't detailed here but typically include reactions at the injection site, fatigue, nausea, immune-related issues like inflammation in organs due to the drug targeting certain proteins on cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is CLDN18.2 positive.

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My cancer's PD-L1 status is known from previous testing.

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I am mostly active and my organs work well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days post last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days post last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days post last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicities (DLTs)

Incidence and severity of AEs

Maximum tolerated or administered dose (MTD, MAD)

Secondary outcome measures

Pharmacokinetic (PK) Parameters: AUCt

Pharmacokinetic (PK) Parameters: AUC∞

Pharmacokinetic (PK) Parameters: Cmax

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation: TJ033721Experimental Treatment1 Intervention

Dose Escalation:: TJ033721 will be administered at up to 8 dose levels (0.1, 0.3, 1, 3, 5, 8, 12 and 15 mg/kg) bi-weekly (Q2W) During dose expansion, TJ033721 will be administered Q2W, starting at the highest dose to have cleared the DLT period. After the conclusion of dose expansion TJ033721 will be administered Q2W at the MAD or RP2D.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

I-Mab Biopharma Co. Ltd.Lead Sponsor

21 Previous Clinical Trials

2,381 Total Patients Enrolled

Media Library

TJ033721 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04900818 — Phase 1

Stomach Cancer Research Study Groups: Dose Escalation: TJ033721

Stomach Cancer Clinical Trial 2023: TJ033721 Highlights & Side Effects. Trial Name: NCT04900818 — Phase 1

TJ033721 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900818 — Phase 1

Frequently Asked Questions

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

Could you please provide the aggregate number of participants in this exploration?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this research is actively searching for participants to join its ranks. The trial first opened its doors on June 29th 2021 and was most recently updated in August 9th 2022. 132 patients need to be enrolled across 12 sites."

Answered by AI

In which locations are the participants engaging with this trial?

"This trial is running in 12 distinct medical centres, a few of which are the Carolina BioOncology Institute of Huntersville, Beth Israel Deaconess Medical Center Dallas and Mary Crowley Cancer Research Aurora."

Answered by AI

Are there any potential hazards associated with TJ033721?

"There is scant clinical evidence backing TJ033721's safety and efficacy, giving it a grade of 1 on the scale."

Answered by AI

What is the goal of this research endeavor?

"The primary evaluation metric of this clinical trial, conducted over a period of 28 days, is the incidence and severity of adverse events. Secondary metrics include pharmacokinetic parameters such as AUC∞ (area under the curve from time zero extrapolated to infinity), Tmax (time of peak concentration) and AUC0-t (AUC from time zero to the last quantifiable concentration)."

Answered by AI

Are there any opportunities to enroll in this study presently?

"The clinical trial is actively seeking participants, as indicated on the official website. It was first posted in late June 2021 and has been updated recently at the start of August 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors

2021. "Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900818.

All > No Stomach For Cancer