NSCLC study: TS-104
Official title 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
ClinicalTrials.gov ID: NCT07814248
What this study is testing
What is TS-104?
TS-104 is an investigational medicine, being studied as a potential treatment for nsclc (non-small cell lung cancer).
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
- This study is testing how well TS-104 works. It is also looking at how safe it is and what side effects it causes.
- Who it's for
- You may be able to join if you have advanced solid tumors like lung or stomach cancer.
- What's involved
- You would get TS-104, a new medicine, by itself. The team will check how your body handles the drug.
- Time commitment
- The study has two parts to find the right amount of medicine.
- Phase 1: an early, usually small safety study
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
- Males \& females ≥18 years of age at the time of consent
- Willingness to provide written informed consent, according to local guidelines.
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma (HNSCC)
- Esophageal cancer
You likely can't join if
- Unresolved toxicity higher than Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v 6.0 (or higher) attributed to any prior...
- people with ongoing sensory or motor neuropathy ≥Grade 2
- people with active or chronic keratitis or corneal disorders, including ulcerations.
- 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...
- people currently receiving cancer therapy (ie, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery, and/or...
See the full eligibility criteria
- Males \& females ≥18 years of age at the time of consent
- Willingness to provide written informed consent, 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
- people must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- All people must have tumor tissue available for retrospective analysis
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- AST and ALT ≤2.5×ULN or ≤5×ULN for people 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...
- 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...
- Male people must agree to use a highly effective method of contraception while on study and for 6 months following the last dose of TS-104
- 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...
- people with ongoing sensory or motor neuropathy ≥Grade 2
- people with active or chronic keratitis or corneal disorders, including ulcerations. people 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...
- people 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...
- 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...
- Major surgery or planned major surgery (excluding placement of vascular access device) within 4 weeks of Cycle 1 Day 1 (C1D1)
- people 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...
- ≥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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Maumee, Ohio, United States
- Portland, Oregon, United States
- Fairfax, Virginia, United States
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, but 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?
This study is enrolling now at Maumee, Ohio, United States; Portland, Oregon, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.