Is NCT07814248 recruiting in Maumee, OH?

Yes, NCT07814248 is currently recruiting participants at its Maumee, OH location. This nsclc (non-small cell lung cancer) clinical trial is actively enrolling qualified participants.

How do I join the nsclc (non-small cell lung cancer) clinical trial in Maumee?

To join this clinical trial in Maumee, 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 Maumee 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.

NSCLC (Non-small Cell Lung Cancer) Clinical Trial in Maumee, OH

About This NSCLC (Non-small Cell Lung Cancer) Study in Maumee

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects with Select Advanced Solid Tumors. The main goals of this study are to: * Find the recommended dose of TS-104 that can safely be given to participants * Learn more about the side effects of TS-104 * Learn more about the effectiveness of TS-104 * Learn more about the pharmacokinetics of TS-104

Sponsor: TwoStep Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Males \& females ≥18 years of age at the time of consent

Willingness to provide written informed consent, according to local guidelines.

Subjects who have histologically or cytologically documented, unresectable locally advanced, or metastatic solid malignancy that is progressing or has failed the minimum therapies listed below or who are intolerant of, ineligible for, or refuse standard of care (SOC) therapy according to local guidelines:

Non-small cell lung cancer (NSCLC)

Head and neck squamous cell carcinoma (HNSCC)

Esophageal cancer

Endometrial cancer

Ovarian cancer

Gastric cancer

Subjects must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

All subjects must have tumor tissue available for retrospective analysis

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Adequate organ function as defined by the following criteria:

AST and ALT ≤2.5×ULN or ≤5×ULN for subjects with liver metastases

Total serum bilirubin ≤1.5×ULN except in the presence of Gilbert's Syndrome where direct bilirubin should be ≤ULN

ANC ≥1.5×109/L

Platelets ≥100×109/L without transfusion support within 14 days prior to study treatment

Hemoglobin ≥9.0 g/dL without transfusion support within 14 days prior to study treatment

Calculated creatinine clearance ≥60 mL/min by Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Coagulation tests ≤1.5×ULN unless subject is receiving anticoagulant therapy, as long as prothrombin time (PT), International Normalized Ratio (INR), or activated partial thromboplastin time (aPTT) is within the therapeutic range of intended use of anticoagulants

Negative serum pregnancy test for women of childbearing potential (WOCBP) at Screening and willingness to use highly effective contraception for the duration of the trial and for 6 months following the last dose of TS-104

Male subjects must agree to use a highly effective method of contraception while on study and for 6 months following the last dose of TS-104

Exclusion Criteria

Unresolved toxicity higher than Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v 6.0 (or higher) attributed to any prior therapy/procedure at Screening, except for alopecia, well-controlled Grade 2 hypothyroidism, or Grade 2 adrenal insufficiency that is actively managed with appropriate therapy

Subjects with ongoing sensory or motor neuropathy ≥Grade 2

Subjects with active or chronic keratitis or corneal disorders, including ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the Investigator.

Known sensitivity to any of the ingredients of TS-104 or MMAE

Prior treatment with tubulin-inhibitor-based drug conjugates, including antibody-drug conjugates (ADCs) with tubulin inhibitor payloads, ie, Emrelis (MMAE payload) for c-Met-high NSCLC or Elahere (DM4 payload) for FRα-high ovarian cancer. For clarity, prior treatment with standard taxane-based chemotherapy (eg, paclitaxel) is permitted.

Subjects currently receiving cancer therapy (ie, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery, and/or tumor embolization) or expected to require any other form of antineoplastic therapy while on study.

Subject with history of other malignancy other than the one for which they participate in the study (exceptions include definitively resected basal cell carcinoma and other in situ cancers) - unless the subject has undergone curative therapy with no evidence of that disease for 3 years

Major surgery or planned major surgery (excluding placement of vascular access device) within 4 weeks of Cycle 1 Day 1 (C1D1)

Subjects who are currently pregnant or breastfeeding

Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, uncontrolled diabetes mellitus, active or chronic bleeding event within 28 days prior to C1D1, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician. This includes any preexisting medical history that could impair the proper assessment of the study results (eg, severe pulmonary function compromise unrelated to underlying malignancy).

≥Grade 3 pulmonary disease unrelated to underlying malignancy

History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at Screening or the presence of residual symptoms

Clinically significant, uncontrolled cardiovascular disease including: myocardial infarction or unstable angina within the last 6 months, symptomatic congestive heart failure (New York Heart Association Classification \>Class II), or serious uncontrolled cardiac arrhythmia within the last 6 months of Screening

History of long QT syndrome or subject whose corrected QT interval measured by Fridericia's method at Screening is prolonged (\>470 msec)

Uncontrolled hypertension, defined as systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management

Current treatment with strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 or inhibitors of P-glycoprotein (P-gp) including herbal or food based

Known active central nervous system metastases.

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 Maumee?

Yes, this clinical trial (NCT07814248) has an active research site in Maumee, OH 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.

NSCLC (Non-small Cell Lung Cancer) Treatment Options in Maumee, OH

If you're searching for nsclc (non-small cell lung cancer) treatment options in Maumee, OH, this clinical trial (NCT07814248) 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 Maumee research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced nsclc (non-small cell lung cancer) 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 nsclc (non-small cell lung cancer) clinical trials near you to find additional studies recruiting in your area.

NSCLC (Non-small Cell Lung Cancer) Clinical Trial in Maumee, OH

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