OncoMatch/Clinical Trials/NCT07181473
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
Is NCT07181473 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies TJ101 for lung cancer (nsclc).
Treatment: TJ101 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Prostate Cancer
Esophageal Carcinoma
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
who have failed standard treatment, or have no standard therapy
Cannot have received: topoisomerase I inhibitor (topotecan, irinotecan, belotecan)
Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal)
Cannot have received: antibody-drug conjugate (sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan)
TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal)
Cannot have received: mitomycin (mitomycin)
Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: nitrosourea
Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: oral fluorouracil-like drug (S-1, capecitabine)
oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration
Cannot have received: palliative radiotherapy
oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration
Cannot have received: chemotherapy
Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101
Cannot have received: biological therapy
Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101
Cannot have received: immunotherapy
Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101
Cannot have received: targeted therapy
Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101
Cannot have received: small molecule inhibitor of tyrosine kinase
targeted therapy (including small molecule inhibitor of tyrosine kinase)
Cannot have received: anti-tumor herbal medicine
Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101
Lab requirements
Blood counts
Hemoglobin (HGB) ≥ 90 g/L; Platelet count (PLT) ≥ 100×10^9/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L; without infusion of blood product, use of G-CSF or other treatments to correct blood count within 14 days
Kidney function
Creatinine clearance ≥ 60 mL/min (Cockcroft and Gault equation)
Liver function
AST and ALT ≤ 2.5 x 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.
Cardiac function
INR ≤ 1.5×ULN; APTT≤1.5×ULN; QTc (Fridericia) ≤ 470 ms; no clinically significant arrhythmia, unstable angina, CHF (NYHA II-IV), or acute MI within 6 months; no history of additional risk factors for Torsades de Pointes; uncontrolled hypertension (SBP ≥160 mm Hg or DBP ≥100 mm Hg on >1 antihypertensive)
Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing. * Hepatic function: AST and ALT ≤ 2.5 x 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: INR ≤ 1.5×ULN; APTT≤1.5×ULN. * Renal function: Creatinine clearance ≥ 60 mL/min (Cockcroft and Gault equation) * 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) ≥ 100×10^9/L; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Florida Cancer Specialists & Research Institute · Orlando, Florida
- Sarah Cannon Research Institute (SCRI) · Nashville, Tennessee
- Oncology Consultants · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07181473 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase I inhibitor, antibody-drug conjugate, mitomycin disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify