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Study of TJ101 for Advanced Solid Tumors

This study is testing a new drug called TJ101 for people with advanced or metastatic solid tumors, including lung, prostate, and esophageal cancers. TJ101 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells that have specific markers (EGFR and B7-H3). The main goals are to find a safe dose of TJ101, understand its side effects, and see if it can shrink tumors. You might be able to join if your cancer has not responded to standard treatments or if there are no standard treatments available. The study is currently unclear about its recruitment status.

Study design
This is a Phase 1, open-label study designed to evaluate TJ101 in up to 72 participants with advanced solid tumors. It starts with dose escalation to find the safest and most effective dose.
What's involved
You would receive TJ101 through an IV (intravenous) infusion. You would also have regular tumor imaging, provide blood samples, and be monitored for side effects.
Compensation
Not stated in the trial record.
Follow-up
You would be monitored for serious adverse events and treatment-emergent adverse events for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07181473

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Phrontline Biopharma
~200 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:TJ101

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose-limiting toxicities
Measured over 21 Days
+3 more outcomes measured

Conditions

Lung Cancer (NSCLC)
Prostate Cancer
Esophageal Cancer
Solid Tumor Malignancies

Explore related trials

Esophageal CarcinomaLung Non-Small Cell CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

7 sites across 7 states
Florida1
Tennessee1
Texas1
Henan1
Hubei1
Zhejiang1
China1

Who to contact

Martin S Olivo, MD
[email protected]
551-427-2578
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hepatic function: AST and ALT ≤ 2.5 x upper limit of normal (ULN); if liver metastases, then ≤ 5 x ULN. Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome.
Albumin ≥3g/dL.
Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN; APTT≤1.5×ULN.
Renal function: Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft and Gault equation) (Cockcroft DW, 1976)
Hematopoietic function (without infusion of blood product, use of G-CSF or other treatments to correct blood count within 14 days): Hemoglobin (HGB) ≥ 90 g/L; Platelet count (PLT) ≥ 100×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; 7. Serum pregnancy test (for female of childbearing potential) negative within 7 days prior to first dosing of study treatment. Male and female patients of childbearing potential must agree to use effective methods of contraception from the time of informed consent, throughout the study and for 6 months after the last dose of the investigational product. 8. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.

What this trial measures

  • Number of participants with Dose-limiting toxicities21 Days

    Measuring the number of patients with Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: Grade 4 neutrophil count decreased lasting \>7 days; Grade ≥3 febrile neutropenia; Grade ≥3 platelet count decreased with clinically significant hemorrhage; Grade 4 anaemia; Non-Hematological toxicities: Death; Hy's law cases; Grade ≥3 non-hematological toxicities.

  • Number of participants with Serious Adverse Events (SAEs)2 years

    Measuring the number of patients with Serious Adverse Events (SAEs)

  • Number of participants with treatment-emergent adverse events (TEAEs)2 years

    Measuring the number of patients with AEs that occur after first study dose till 30 days after the last dose

  • Number of participants with treatment-related adverse events (TRAEs)2 years

    Measuring the number of patients with treatment-related TEAEs