Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Atezolizumab

Immunoglobulins

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

TJ004309

This expanded access protocol was designed to provide TJ004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.

Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer

Expanded Access Protocol for an Intermediate Size Population-use of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

I-Mab Biopharma US Limited

Neoplasms, Second Primary

TJ004309 will be dose escalated in a 3+3 design in combination with atezolizumab.

Charles Theuer, MD, PhD

This is a multicenter, open label, Phase 1 dose escalation study of TJ004309 in combination with standard dose atezolizumab in patients with advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy.

Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

A Phase 1 Dose-Escalation Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer

Evaluate safety and tolerability and determine a recommended Phase 2 dose of TJ004309 when combined with standard dose atezolizumab in patients with advanced or metastatic cancer. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and coded using MedDRA 14.1.

Determine the Phase 2 dose of TJ004309 as a single agent

Trough (pre-dose and post-dose) serum TJ004309 concentrations will be measured when given as a single agent and with atezolizumab

Trough (pre-dose and post-dose) serum atezolizumab concentrations will be measured when given with TJ004309

The number of patients who develop immunogenicity to TJ004309 (anti-product antibody development) will be determined.

The number of patients who develop immunogenicity to atezolizumab (anti-product antibody development) will be determined.

Antitumor activity will be assessed by the response rate by iRECIST and RECIST 1.1

Tracon Pharmaceuticals Inc.

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Head and Neck Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. This clinical study includes two cohorts: Cohort 1 will include Immuno-Oncology (IO) treatment naïve ovarian cancer (OC) patients who have progressed on or after platinum therapy; and Cohort 2 will include patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer (GC), triple negative breast cancer (TNBC), or ovarian carcinoma (OC) with PD-L1 expression ≥ 1%. Additional cohorts for selected tumor types might be added later.

A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors

Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumors (RECIST v1.1) and iRECIST for target lesions assessed by CT or MRI

Treatment-emergent adverse event (TEAE) is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) Number of subjects with significant changes in vital signs, physical examinations, and clinical laboratory findings

Assessed by number of participants with clinically significant laboratory values.

Assessed by number of participants with clinically significant vital sign values

Assessed by number of participants with clinically significant abnormal physical examination results

Time from documentation of tumor response to disease progression assessed among patients who had an objective response

Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

Overall survival (OS) will be calculated for each subject as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of death from any cause.

AUC0-T is the area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval after the first infusion

Cmax is maximum drug concentration observed

TJ004309 will be dose escalated in a 3+3 design in Monotherapy or combination with Toripalimab

Toripalimab

This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced 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 confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.

A Phase I/II Study of TJ004309 for Advanced Solid Tumor

A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer	NCT04869501	Cancer	TJ004309 Atezolizumab	-	I-Mab Biopharma US Limited
Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer	NCT03835949	Solid Tumor Metastatic Canc...	TJ004309 Atezolizumab	18 Years -	Tracon Pharmaceuticals Inc.
A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors	NCT05001347	Ovarian Cancer Head and Neck C... Non Small Cell ... Gastrointestina... Triple Negative... Ovarian Carcino...	TJ004309	18 Years -	I-Mab Biopharma US Limited
Study of TJ004309 in Combination With Atezolizumab (Tecentriq®) in Patients With Advanced or Metastatic Cancer	NCT03835949	Solid Tumor Metastatic Canc...	TJ004309 Atezolizumab	18 Years -	Tracon Pharmaceuticals Inc.
A Phase I/II Study of TJ004309 for Advanced Solid Tumor	NCT04322006	Advanced Solid ...	TJ004309 Toripalimab	18 Years -	TJ Biopharma Co., Ltd.
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer	NCT04869501	Cancer	TJ004309 Atezolizumab	-	I-Mab Biopharma US Limited
A Phase I/II Study of TJ004309 for Advanced Solid Tumor	NCT04322006	Advanced Solid ...	TJ004309 Toripalimab	18 Years -	TJ Biopharma Co., Ltd.
Expanded Access Study of TJ004309 in Patients With Advanced or Metastatic Cancer	NCT04869501	Cancer	TJ004309 Atezolizumab	-	I-Mab Biopharma US Limited

Spots Global Cancer Trial Database for tj004309

Every month we try and update this database with for tj004309 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tj004309

Every month we try and update this database with for tj004309 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tj004309 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.