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

TJ Biopharma Co., Ltd.

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: TJ004309

Drug: Toripalimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04322006

TJ004309STM102

Details and patient eligibility

About

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.

Enrollment

376 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
In the dose-escalation phase, subjects with advanced solid tumors that are histologically or cytologically confirmed to be unresectable or have metastasized, subjects with standard treatment failure or intolerance (disease progression, or inability to tolerate chemotherapy, targeted therapy, etc.), or subjects without effective treatment.
Synchronous dose expansion (will base on dose-escalation phase)
At least one measurable disease by modified RECIST 1.1 for immune based therapeutics V1.1
Expected survival ≥ 3 months
Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 times the ULN
- Absolute neutrophil count (ANC) ≥ 1.5 ×109/ L
- Platelets ≥ 100×109/ L without transfusion support within 28 days prior to study treatment
- Hemoglobin ≥ 9.0 g/dL without transfusion support within 14 days prior to study treatment
- Serum creatinine ≤ 1.5 times the ULN or Creatinine clearance > 30 mL/min by Cockcroft-Gault formula
- International normalized ratio (INR) in normal range
Serum pregnancy test must be negative for childbearing female prior to study treatment
The man have reproductive ability or childbearing female (refers to men and women not on birth control operation, and the menopause women), must use the highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive device, abstemious sexual desire or barrier contraceptive method combined with spermicide) during the study, and sustain contraception 6 months after the last dose
Willingness and ability to consent for self to participate in study and comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

Pregnancy or breastfeeding
Prior T-cell therapy
Receipt of systemic anticancer therapy or ≥ 5 times the elimination half-life of the drug has elapsed within 2 weeks prior to study treatment (Note: whichever is shorter shall prevail.)
Exist ≥ 2 kinds of primary tumor, expect cured preinvasive carcinoma and basaloma. (patients are not excluded if ≥ 5 years treatment with other tumor prior to study treatment.)
Autoimmune disease requiring treatment within the past twelve months only requiring related treatment replacement
Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications more than 7 days within 14 days prior to study treatment (Note: inhaled and topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.)
Current treatment on another therapeutic clinical trial within 14 days prior to study treatment
Major surgical procedure or significant traumatic injury within 4 weeks prior to study treatment and no date of surgery (if applicable) or anticipated need for a major surgical procedure planned during study treatment
Chest radiotherapy ≤ 4 weeks, wide field radiotherapy ≤ 4 weeks (defined as > 50% of volume of pelvic bones or equivalent) or palliative radiotherapy ≤ 2 weeks prior to study treatment
Brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease, unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for central nervous system disease over the 2 weeks prior to study treatment
Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible.
Known human immunodeficiency virus (HIV) positive
Ascites or pericardial effusion that can not be control
History of or active interstitial lung disease
Hypertension is not well controlled by medication. Hypertension defined as blood pressure (BP) systolic > 150 or diastolic > 90 mm Hg (Note: Initiation or adjustment of antihypertensive medication prior to study entry is allowed provided that the average of the three most recent BP readings prior to study enrollment is ≤150/90 mm Hg.)
Cardiovascular diseases with clinical significance, include phase II-III cardiac insufficiency defined by New York Heart Association, myocardial infarction (MI) within 3 months prior to study treatment, symptomatic congestive heart failure, cerebral infarction within 3 months prior to study treatment, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
Deep-venous thrombosis within 6 months prior to study treatment (except treated without warfarin 2 weeks prior to study treatment)
Thrombolytic use (except to maintain IV catheters) within 10 days prior study treatment
Any active infection requiring systemic treatment
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study