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TJ033721 for Esophageal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Esophageal Cancer+6 MoreTJ033721 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Metastatic Cancer
  • Esophageal Cancer
  • Gastroesophageal Junction Cancer
  • Advanced Cancer
  • Solid Tumors
  • Stomach Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 5 Secondary · Reporting Duration: up to 100 days post last dose

28 Days
Maximum tolerated or administered dose (MTD, MAD)
28 days
Dose-limiting toxicities (DLTs)
Day 100
Incidence and severity of AEs
Pharmacokinetic (PK) Parameters: AUC∞
Day 100
Pharmacokinetic (PK) Parameters: AUCt
Pharmacokinetic (PK) Parameters: Cmax
Pharmacokinetic Parameters: T1/2
Pharmacokinetic Parameters: Tmax

Trial Safety

Safety Progress

1 of 3

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1
Dose Escalation (Phase 1)
1
Dose Expansion
1
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Trial Design

1 Treatment Group

Dose Escalation: TJ033721
1 of 1

Experimental Treatment

132 Total Participants · 1 Treatment Group

Primary Treatment: TJ033721 · No Placebo Group · Phase 1

Dose Escalation: TJ033721
Drug
Experimental Group · 1 Intervention: TJ033721 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 100 days post last dose

Who is running the clinical trial?

I-Mab Biopharma Co. Ltd.Lead Sponsor
19 Previous Clinical Trials
2,013 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People with advanced or metastatic solid tumors that haven't responded to standard therapy, or who can't have standard therapy, or who don't qualify for standard therapy.
Advanced gastric cancer, gastroesophageal junction carcinoma, esophageal adenocarcinoma, and pancreatic ductal adenocarcinoma that are not being treated with any standard therapies or those therapies are not suitable for the individual.
A person with an ECOG performance status of 0 or 1 who also has adequate organ function is considered to have a good prognosis.
The tumor must have positive expression of CLDN18.2, as determined by the CLDN18.2 IHC assay.
References

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