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

• Sponsor: I-Mab Biopharma Co. Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04322006
• Collaborator: (none)
• Enrollment: 376
• Locations: 26
• Arm: 1
• Anticipated Duration (Months): 42.7
• Patients Per Site: 14.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is a phase I/II study of single drug TJ004309 and PD-1 monoclonal antibody injection 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: PD-1 monoclonal antibody injection; Drug: TJ004309 Injection	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 376 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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 PD-1 Monoclonal Antibody Injection Combine Treatment for Advanced Solid Tumor
• Actual Study Start Date: May 9, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TJ004309 Injection 2mg/kg~20mg/kg TJ004309 Injection is administered once a week for a treatment cycle every 28 days	Drug: PD-1 monoclonal antibody injection; 15mg/kg~20mg/kg TJ004309 Injection in combination with PD-1 monoclonal antibody injection every 2 weeks for a treatment cycle every 28 days; Drug: TJ004309 Injection; 2mg/kg~20mg/kg TJ004309 Injection is administered once a week for a treatment cycle every 28 days

Outcome Measures

Primary Outcome Measures

1. Dose Limiting Toxicities(DLT) [28days after first dose]

   The safety and tolerance of TJ004309

2. MTD [2 years]

   Maximum tolerated dose (MTD)

3. MED [2 years]

   Maximum effective dose (MED)

4. Recommend dose of TJ004309 [2 years]

   Recommend dose of TJ004309

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
2	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China
3	Army Medical Center of PLA	Chongqing	Chongqing	China
4	Chongqing Cancer Hospital	Chongqing	Chongqing	China
5	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080
6	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong	China
7	The First Hospital of China Medical University	Guangzhou	Guangdong	China
8	Cancer Hospital affiliated to Shantou University Medical College	Shantou	Guangdong	China
9	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
10	Harbin Medical University Cancer Hospital	Haerbin	Heilongjiang	China
11	Henan Cancer Hospital	Zhengzhou	Henan	China
12	Hubei Cancer Hospital	Wuhan	Hubei	China
13	Hubei Cancer Hospital	Wuhan	Hubei	China
14	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
15	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
16	Hunan Cancer Hospital	Changsha	Hunan	China
17	Hunan Cancer Hospital	Changsha	Hunan	China
18	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China
19	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
20	The First Bethune Hospital of Jilin University	Changchun	Jilin	China	130021
21	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning	China
22	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi	China
23	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
24	Sichuan Cancer Hospital	Chengdu	Sichuan	China
25	Yunnan Cancer Hospital	Kunming	Yunnan	China
26	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hanzhou	Zhejiang	China

Sponsors and Collaborators

• I-Mab Biopharma Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: I-Mab Biopharma Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04322006
• Other Study ID Numbers: TJ004309STM102
• First Posted: Mar 26, 2020
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Antibodies; Antibodies, Monoclonal

Study Results

No Results Posted as of Aug 4, 2022