The Safety, Dosimetry and Efficacy of 177Lu-INN805 in Patients With Malignant Solid Tumors

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFindCure Biosciences (ZhongShan) Co., Ltd.

About this trial

This study is a prospective, single-arm, open-label, dose-escalation study. A total of 4 dose groups were pre-defined in this study. The drug was administered once every 6 weeks.The drug would be administered for 1 to 4 cycles. The dosing schedule and dose could also be adjusted according to the patient's condition. After each dose group completed the enrollment and DLT observation, based on the participant's safety tolerance, radiation dosimetry, and preliminary efficacy evaluation results, it was decided whether to adjust the dose of the subsequent dose groups or to suspend the dose escalation.

Eligibility criteria

Qualifiers

Aged 18 to 75 years old male and female.

Patients with advanced malignant solid tumors who have failed standard treatments.

According to RECIST 1.1, there is at least one measurable lesion.

ECOG performance status 0-1.

Disqualifiers

Received anti-tumor therapy within 4 weeks before enrollment.

Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.

Have undergone surgery within 4 weeks before enrollment.

Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).

Trial design

Treatments tested in this trial

  • INN805

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

FindCure Biosciences (ZhongShan) Co., Ltd.

Lead sponsor

Affiliated Hospital of Jiangnan University

Collaborator