Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byJaffer A. Ajani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Mebiopharm Co., Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing MBP-426, a new medication, in patients whose stomach or esophagus cancer did not respond to initial treatments. The study aims to find the best dose that works well and has fewer side effects.

Eligibility Criteria

Inclusion Criteria

Advanced or metastatic solid tumor malignancy that is refractory to STD therapy, or that has relapsed after STD therapy, or for which conventional therapy is not reliably effective, or no effective therapy is available.

Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.

Age ≥18.

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Treatment Details

Interventions

MBP-426 (Anti-metabolites)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Study of MBP-426/leucovorin/5-FUExperimental Treatment1 Intervention

Study of MBP-426/leucovorin/5-FU. MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered ata dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2.