Actively Recruiting
A Phase I, First in Human, Open-label Dose Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics, Preliminary Efficacy and Immunogenicity of TJ101 in Patients With Advanced/Metastatic Solid Tumors
Led by Phrontline Biopharma · Updated on 2026-01-12
200
Participants Needed
7
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TJ101, an investigational antibody-drug conjugate (ADC), in adults with advanced or metastatic solid tumors who have no remaining standard treatment options. This Phase I, first-in-human trial aims to determine the maximum tolerated dose and recommended dose for expansion of TJ101, while assessing its safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor effects. Participants will receive intravenous infusions of TJ101 every three weeks, either at escalating doses during dose escalation or at selected doses during dose expansion. The study includes two parts: Phase Ia to find safe dosage levels using a 3+3 design with up to 72 patients, and Phase Ib to further evaluate safety and anti-tumor activity in 40-180 patients across tumor-specific groups. Treatment continues until disease progression, unacceptable toxicity, withdrawal, or investigator decision. During the trial, participants will undergo regular tumor imaging every 6 to 12 weeks to monitor response, provide blood samples for pharmacokinetic and biomarker analyses, and have ongoing safety monitoring including lab tests, vital signs, ECGs, eye exams, and skin checks. Follow-up includes a 30-day safety check after the last dose and survival follow-up every three months until death or study end. The study is expected to last about 2 to 3 years in total.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosed with advanced or metastatic solid tumors who have failed standard treatment or have no standard therapy available
- At least one measurable tumor lesion by RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function as defined by specific lab test criteria within 7 days before dosing
- Negative pregnancy test for females of childbearing potential within 7 days before dosing
- Willingness to use effective contraception during the study and for 6 months after last dose
- Ability and willingness to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Prior treatment with topoisomerase 1 inhibitors or TOP1i-based antibody-drug conjugates
- Known hypersensitivity to TJ101 components or severe reactions to monoclonal antibodies
- Recent treatment with mitomycin, nitrosoureas, oral fluorouracil-like drugs, radiotherapy, chemotherapy, biological therapy, immunotherapy, major surgery, or other anti-tumor therapies within specified timeframes
- Use of strong or moderate CYP3A4 inhibitors within 3 half-lives
- Participation in other investigational drug studies within 28 days or 2 half-lives
- Unresolved toxic effects from previous anti-tumor treatments exceeding certain severity
- History or current presence of certain lung diseases including interstitial lung disease
- Severe eye conditions increasing risk of corneal damage
- Uncontrolled or significant cardiovascular diseases including prolonged QT interval, arrhythmias, unstable angina, congestive heart failure, recent myocardial infarction, or uncontrolled hypertension
- Active hepatitis B or C infection unless controlled as defined
- Known HIV infection
- Recent severe infections or use of therapeutic antibiotics within 2 weeks
- Active central nervous system metastases unless stable and controlled
- Other recent malignancies within 3 years except certain treated skin or in situ cancers
- Lactating or breastfeeding females
- Any other condition that may affect study participation or results as judged by the investigator
AI-Screening
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Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) within 28 days prior to first dose
Duration - Up to 3 weeks (first cycle DLT evaluation window)
Participants receive escalating doses of TJ101 intravenously every 3 weeks to determine the maximum tolerated dose and recommended dose for expansion.
1 infusion visit every 3 weeks during dose escalation
Duration - Continued until progression or discontinuation
Participants receive TJ101 intravenously every 3 weeks at the selected dose level until disease progression, unacceptable toxicity, withdrawal, or investigator decision.
Infusion on Day 1 of each 21-day cycle; repeated every 3 weeks
Duration - Up to 2 years or until death/study termination
Participants are monitored for safety and survival after treatment ends, including a 30-day safety follow-up and survival follow-up every 3 months until death or study termination.
1 safety follow-up visit 30 days after last dose; survival follow-up every 3 months
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
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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