A Phase I Clinical Study Evaluating the Safety, Tolerability, MTD or MAD, PK, PD, and Antitumor Activity of TJ210001(a Fully Human C5aR Monoclonal Antibody) in Subjects With Advanced Solid Tumors

I-Mab Biopharma US Limited1 site in 1 country25 target enrollmentDecember 31, 2023

ConditionsAdvanced Solid Tumor

InterventionsTJ210001 Injection

DrugsTJ210001 Injection

Overview

Phase: Phase 1
Intervention: TJ210001 Injection
Conditions: Advanced Solid Tumor
Sponsor: I-Mab Biopharma US Limited
Enrollment: 25
Locations: 1
Primary Endpoint: Rate and Severity of Dose-limiting toxicity （DLT）
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase I clinical study evaluating TJ210001 in the treatment of subjects with advanced solid tumors

Detailed Description

This study is a phase I clinical study evaluating TJ210001 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the TJ210001 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of TJ210001 monotherapy.

Registry

clinicaltrials.gov

Start Date

December 31, 2023

End Date

December 31, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

I-Mab Biopharma US Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first administration of the study drug, except for the following items:
•Nitrosourea or Mitomycin C has been used within 6 weeks before the first administration of the study drug;
•Oral fluorouracil and small molecule targeted drugs are used 2 weeks before the first administration of the study drug or 5 half-lives of the drug (whichever is longer);
•Chinese medicine with anti-tumor indications is used within 2 weeks before the first administration of the study drug.
•Have received other unmarketed clinical study drugs or treatments within 4 weeks before the first administration of the study drug;
•Have received major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first administration of the study drug, or the elective surgery will be required during the study period;
•Have received systemic glucocorticoids (prednisone\> 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration of the study drug; Except for the following situations: Use topical, eye, intra-articular, intranasal and inhaled glucocorticoid therapy; short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy)
•Have received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc. within 14 days before the first administration of study drug;
•Have received the live attenuated vaccine within 4 weeks before the first administration of study drug;
•Have received C5aR inhibitor treatment in the past;