Actively Recruiting
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
Led by Phrontline Biopharma · Updated on 2026-01-12
200
Participants Needed
7
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors. The main objectives of this study are : * To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101 * to show preliminary antitumor activity in patients with advanced solid tumors Participants will: * Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. * Undergo regular tumor imaging to assess response. * Provide blood samples for pharmacokinetics (PK) and biomarker analysis. * Be monitored for side effects and overall tolerability. This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
CONDITIONS
Official Title
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological and/or cytological diagnosis of advanced or metastatic solid tumors with no effective standard treatment
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Men or women aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Adequate organ and laboratory function within 7 days prior to first dosing, including liver, kidney, blood, and coagulation parameters
- Negative serum pregnancy test for females of childbearing potential within 7 days prior to first dosing
- Agreement to use effective contraception during the study and for 6 months after the last dose
- Willingness to participate, understand, and comply with study procedures and visits
You will not qualify if you...
- Prior treatment with topoisomerase 1 inhibitors or related antibody-drug conjugates
- Known allergy to TJ101 components or severe reactions to monoclonal antibodies
- Recent treatment with mitomycin, nitrosoureas, oral fluorouracil-like drugs, or palliative radiotherapy within specified timeframes before first dose
- Use of strong or moderate CYP3A4 inhibitors within 3 half-lives prior to first dose
- Participation in other investigational drug studies within 28 days or 2 half-lives prior to first dose
- Unrecovered toxic effects from previous anti-cancer therapy beyond Grade 1 (except alopecia and skin pigmentation)
- History or presence of interstitial lung disease or pneumonitis
- Severe eye conditions increasing risk of corneal damage
- Uncontrolled or significant cardiovascular diseases including prolonged QT interval, arrhythmias, recent heart attack, or uncontrolled hypertension
- Active or uncontrolled hepatitis B or C infections not meeting specified criteria
- Known HIV infection
- Recent severe infections or antibiotic treatments as specified
- Active central nervous system metastases unless stable and controlled
- Other malignancies within 3 years prior to treatment except certain treated skin or superficial cancers
- Lactating or breastfeeding females
- Any other conditions or factors that may interfere with study participation or results as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Florida Cancer Specialists & Research Institute
Orlando, Florida, United States, 32827
Actively Recruiting
2
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
Actively Recruiting
3
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
5
Union Hospital of Tongji Medical College
Wuhan, Hubei, China
Not Yet Recruiting
6
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
7
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
M
Martin S Olivo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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