A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor

NCT05148533 | Terminated Phase 1 DMC

• 1 other identifier: TJ011133STM104
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 22

Brief Summary

This study is a phase I/II study of single drug TJ011133 and Toripalimab combine treatment forAdvanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to comfirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safty, effectiveness, PK, PD and biomarker properties for effective subjects.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events

  The NCI CTCAE V5.0 will be used to assess adverse events on this study

  throughout the dose escalation assessed to 1year

• The Objective Response Rate(ORR)

  The Objective response rate will be assessed by RECIST v1.1 criteria in this study.

  Through the dose expansion assessed to 1 year

Study Arms (1)

TJ1133 Injection

EXPERIMENTAL

Drug: TJ1133 Injection

Interventions

TJ1133 Injection DRUG

TJ011133 (30 mg/kg, 45 mg/kg,QW) in combination with toripalimab injection (240 mg, Q3W)

TJ1133 Injection

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥18 years old (inclusive);
• ECOG score: 0-1 points;
• Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, and those who failed or were intolerant to standard therapy, or have no effective treatment options:
• Enrollment of patients with advanced solid tumors in the dose escalation phase;
• Subjects with melanoma, gastric cancer, head and neck squamous cell carcinoma will be enrolled in the dose expansion phase;
• Collect FFPE tumor tissue slides: Collect 12 to 13 archival pre-treatment (mandatory) and 10 on-treatment (optional) paraffin sections from fresh tumor biopsies.
• Subjects with at least 1 measurable lesion as per RECIST V1.1;
• Expected survival ≥ 3 months;
• Main organ function is normal (within 7 days prior to the first dose), i.e., relevant laboratory test criteria are met, and some laboratory indicators meet the following criteria:
• a) Hematology: i. Hemoglobin ≥ 11.0 g/dL or 6.8 mmol/L, received no blood transfusion within 7 days of evaluation, and without dependence on erythropoietin (EPO), ii. Absolute neutrophil count (ANC) ≥1.5×109/L, iii. Platelets ≥ 75×109/L; b) Renal function: i. Creatinine clearance ≥ 45 mL/min (calculated by Cockcroft-Gault formula), ii. Qualitative urine protein ≤ 1+; or qualitative urine protein ≥ 2+, 24-hour urine protein \< 1 g; c) Liver function i. Serum total bilirubin ≤ 1.5 × ULN, ii. Both aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 2.5 × ULN, iii. Serum albumin ≥ 2.8 g/dL (received no albumin infusion within 2 weeks prior to blood collection); d) Coagulation function: i. International normalized ratio (INR), or prothrombin time (PT) ≤ 1.5 x ULN, or PT parameters can be maintained ≤ 1.5 x ULN with an anticoagulant at a stable dose, ii. Activated partial thrombin time (aPTT) ≤ 1.5 × ULN, or aPTT parameters can be maintained ≤ 1.5 × ULN with the use of anticoagulants;
• Male subjects with reproductive potential and female subjects with pregnancy potential (which refer to men or women who have not been surgically sterilized, and women who are not post-menopausal) must use highly effective contraceptive methods such as oral contraceptives, intrauterine devices, sexual abstinence or barrier contraception in conjunction with spermicides during the course of the study and until 6 months after the last dose;
• Subjects who are willing to participate in this study and sign the ICF, have good compliance and cooperate with the follow-up.
• Subjects must be excluded if they meet any of the following criteria:
• Pregnant or breast-feeding women;
• Have received prior treatment with CD47 or SIRPα inhibitors;

You may not qualify if:

• Pregnant or breast-feeding women;
• Prior treatment with CD47 or SIRPα inhibitors;
• Prior CAR-T cell therapy;
• Subjects who have received systemic anti-tumor therapies within 4 weeks prior to the initiation of treatment or within five half-lives (whichever is shorter) of the study drug, except for the following;
• Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study drug;
• Oral fluorouracils and small molecule targeted agents are within 2 weeks prior to the first dose of study drug or within 5 half-lives of the drug, whichever is longer;
• Traditional Chinese medicine with anti-tumor indications is within 2 weeks prior to the first dose of study drug.
• Subjects who had or have two or more primary tumors cannot be enrolled, except for cured carcinoma in situ and basal cell carcinoma. Subjects with concomitant tumors that have been stable for more than 5 years before enrollment in the study can be enrolled;
• Subjects who have active auto-immune diseases requiring systemic treatment with immunomodulatory drugs within 12 months prior to treatment initiation, but relevant alternative therapies are allowed;
• Subjects who have received systemic treatment with corticosteroids (more than 10 mg/day prednisone equivalent) or other immunosuppressants for more than 7 days within 2 weeks prior to treatment initiation (inhaled or topical steroids or adrenal replacement therapy in excess of 10 mg prednisone equivalents is permitted in the absence of active auto-immune disease);
• Subjects who have participated in clinical trials (including investigational vaccines), and received interventional and investigational treatment with invasive and investigational medical devices within 4 weeks prior to the initiation of treatment;
• Subjects who have experienced major surgery or severe trauma within 4 weeks prior to treatment initiation, or who are recovering, but which will exert an impact on the study as judged by the investigator, or who have surgical arrangements during their participation in the study;
• Chest radiotherapy or expanded field radiotherapy (defined as more than 50% pelvic bone mass or equivalent) within 4 weeks prior to the initiation of treatment, or palliative radiotherapy within 2 weeks prior to the initiation of treatment;
• Presence of symptomatic metastases to the central nervous system (CNS) and neurological instability within 2 weeks prior to initiation of dosing or a need to increase the dose of steroids to control CNS symptoms;
• HBsAg positive and HBV-DNA copies \> 500 IU/ml or lower limit of detection at the site (only if the lower limit of detection at the site is above 500 IU/ml); HCV antibody positive and result of HCV-RNA quantitative assay above the ULN;

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (22)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 33004, China

Location

Anhui Province Cancer Hospital

Hefei, Anhui, 230000, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Medical University Affiliated Tumor Hospital

Guangzhou, Guangdong, 510095, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530031, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

HuNan Cancer Hospital

Changsha, Hunan, 410031, China

Location

The first affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130028, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Shandong Tumor Hospital

Jinan, Shandong, 250117, China

Location

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200011/201999, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610044, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China

Location

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: November 25, 2021
• First Posted: December 8, 2021
• Study Start: December 30, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (22)