Is NCT07181473 recruiting in Orlando, FL?

Yes, NCT07181473 is currently recruiting participants at its Orlando, FL location. This lung cancer (nsclc) clinical trial is actively enrolling qualified participants.

How do I join the lung cancer (nsclc) clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Cancer (NSCLC) Clinical Trial in Orlando, FL

About This Lung Cancer (NSCLC) Study in Orlando

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

Sponsor: Phrontline Biopharma

Who Can Participate

Inclusion 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 (ANC) ≥ 1.5×109/L;

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.

Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.

Exclusion Criteria

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);

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 administration; 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; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;

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 interventional clinical studies (participation in survival follow-up is allowed);

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 loss) that will not increase the safety risk may be eligible at the discretion of the Investigator.

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 arrhythmia, unstable angina pectoris, congestive heart failure (class II-IV of New York Heart Association \[NYHA\]) or acute myocardial infarction within preceding 6 months. History of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). Uncontrolled hypertension defined as systolic BP ≥160 mm Hg or diastolic BP ≥100 mm Hg while receiving more than one kind of antihypertensive drug.

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 sponsor and investigator: Patients with active hepatitis B: HBV DNA ≤500 IU/mL during Screening. Patients who are hepatitis C virus antibody positive (HCV Ab+), who have controlled infection (HCV RNA≤ULN by polymerase chain reaction \[PCR\] either spontaneously or in response to a successful prior course of anti-HCV therapy at Screening). Patients with controlled infections must undergo periodic monitoring of HCV RNA as per treating physician.

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 therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, and who received prophylactic antibiotics (e.g., for the prevention of urinary tract infection or chronic obstructive pulmonary disease);

Active central nervous system (CNS) metastases or meningeal metastases. Subjects 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 (ie, imaging shows no progression of the brain lesion and neurologically relevant symptoms are stable), and require a dose of prednisone of ≤20 mg/day (or equivalent dose).

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 carcinoma that have received radical treatment and no evidence of disease recurrence) will confound safety/efficacy of this trial or pose a risk to the participants;

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 physical conditions, abnormal treatment or laboratory tests, and the subject's unwillingness to comply with all procedures, restrictions, and requirements of the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07181473) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Cancer (NSCLC) Treatment Options in Orlando, FL

If you're searching for lung cancer (nsclc) treatment options in Orlando, FL, this clinical trial (NCT07181473) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lung cancer (nsclc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung cancer (nsclc) clinical trials near you to find additional studies recruiting in your area.

Lung Cancer (NSCLC) Clinical Trial in Orlando, FL

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