A Study Evaluating TJ210001 in the Treatment of Subjects With Advanced Solid Tumors

NCT04947033 | Unknown Phase 1 DMC

• 1 other identifier: TJ210001STM102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Rate and Severity of Dose-limiting toxicity （DLT）

  up to 28 days after last dose of study drug

• Maximum tolerated dose (MTD)

  up to 21days following first dose

Study Arms (1)

TJ210001 Injection

EXPERIMENTAL

Single Arm Dose expansion

Drug: TJ210001 Injection

Interventions

TJ210001 Injection DRUG

The test drug TJ210001 will be preset with 5 escalation dose levels: 0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg and 15mg/kg, administered once a week.

TJ210001 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female aged 18 or above;
• ECOG score: 0-1;
• The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up.
• Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
• Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
• Subjects who have recovered from the toxicity of previous anti-tumor therapy (CTCAE v5.0) to ≤ Grade 1 or baseline (except for alopecia and neuropathy);
• Expected survival period ≥ 3 months;
• The main organs are functioning normally and the laboratory indicators meet the following standards:
• Absolute neutrophil count (ANC) ≥ 1500/μL (≥1.5 ×109/L), and have not received growth factor or colony stimulating factor treatment within 7 days before the start of the study;
• Platelets ≥ 75,000/uL (≥100×109/L), and have not received platelet therapy within 14 days before the start of the study;
• Hemoglobin ≥8.5g/dL, and have not received blood transfusion treatment in the 14 days before the start of the study (have not received erythropoietin within 3 days before the start of the study);
• Adequate renal function and serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 45 mL/min (calculated by Cockcroft-Gault formula);
• Serum total bilirubin ≤ 1.5 × ULN; if diagnosed with Gilbert's disease, serum total bilirubin ≤ 3.0 × ULN; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3× ULN, or ≤5×ULN for subjects with liver metastasis;
• Activated partial thromboplastin time (aPTT) ≤1.5×ULN; International normalized ratio (INR) ≤1.5×ULN (except for anticoagulants with stable doses);
• QT interval for QTcF correction and/or QTcB correction of electrocardiogram: male ≤450 ms, female ≤470 ms;

You may not qualify if:

• 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;
• Those who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
• The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade evaluation ≤ grade 1 (except for the toxicity that the investigator judges to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.);
• Those who have an active infection 1 week before the first administration of the study drug and currently require systemic anti-infective treatment;
• Have a history of immunodeficiency, including HIV antibody test positive ;
• Active hepatitis B (HBsAg positive and HBV-DNA \> the lower limit of detection of the study center). For subjects who are HBsAg positive but HBV-DNA negative, if the antiviral therapy is needed judged by investigator, the subjects will not be excluded; Hepatitis C virus infection (anti-HCV positive);

Sponsors & Collaborators

• I-Mab Biopharma US Limited: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 310000, China

RECRUITING

Study Officials

• Jin Li

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingling Gu

CONTACT

021-60575734; lingling.gu@i-mabbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: December 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)