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 (May 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
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 →
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