BridgeMD
Tests treatment safety and results for Lung Cancer (NSCLC)
Official title A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07181473
What this study is testing
What is TJ101?
TJ101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
- Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
- Men or women ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.
- Life expectancy of ≥ 12 weeks;
You likely can't join if
- Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates...
- Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;
- Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1...
- Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;
- Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ101; Current participation in other...
- Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V5.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with...
See the full eligibility criteria
- Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
- Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
- Men or women ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.
- Life expectancy of ≥ 12 weeks;
- 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 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...
- 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...
- Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
- 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...
- Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;
- Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first...
- Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;
- Received an investigational drug within 28 days or 2 half-lives (whichever is shorter) prior to first dose of TJ101; Current participation in other treatment clinical studies (participation in survival follow-up is...
- Toxic effects of prior anti-tumor therapy have not recovered to NCI-CTCAE V5.0 Grade ≤1 (excluding alopecia and skin pigmentation). Subject with irreversible toxicities caused by prior anti-tumor therapy (eg, hearing...
- Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis can't be ruled out by imaging at screening.
- Presence of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other severe conditions that may increase the risk of corneal epithelial damage at the discretion of investigator.
- Uncontrolled or significant cardiovascular disease, including: Prolongation of the average Corrected QT interval (QTc, Fridericia's correction formula used) (\> 470 ms regardless of sex). Clinically significant...
- For patients with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, only the following patients may be eligible as evaluated by the...
- Known HIV infection;
- Severe infection, including but not limited to hospitalization due to infection, bacteraemia, or severe pneumonia complications, occurs within 4 weeks prior to initiation of study treatment; Or patients who received...
- Active central nervous system (CNS) metastases or meningeal metastases. people may be enrolled in the study if their CNS metastases have received adequate local therapy and have been clinical stable for at least 4 weeks...
- Other malignancies within 3 years prior to initiation of TJ101 treatment (other than non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder...
- Female patients who are lactating or breastfeeding.
- The investigator believes that the subject may have other factors that may affect the results of the study and interfere with the subject's participation in the entire study process, including previous or existing...
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Hangzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Nashville, Tennessee, United States; Houston, Texas, United States; Zhengzhou, Henan, China; Wuhan, Hubei, China; Hangzhou, Zhejiang, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.