OncoMatch/Clinical Trials/NCT07814248
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
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 Advanced Solid Tumors
Is NCT07814248 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies TS-104 for nsclc (non-small cell lung cancer).
Treatment: TS-104 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Ovarian Cancer
Esophageal Carcinoma
Gastric Cancer
Endometrial Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: tubulin-inhibitor-based drug conjugate (Emrelis, Elahere)
Exception: prior treatment with standard taxane-based chemotherapy (e.g., paclitaxel) is permitted
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.
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelets ≥100×10^9/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; Coagulation tests ≤1.5×ULN unless subject is receiving anticoagulant therapy, as long as PT, INR, or aPTT is within the therapeutic range of intended use of anticoagulants
Kidney function
Calculated creatinine clearance ≥60 mL/min by Cockcroft-Gault formula or CKD-EPI
Liver function
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
Adequate organ function as defined by the following criteria: 1. AST and ALT ≤2.5×ULN or ≤5×ULN for subjects with liver metastases 2. Total serum bilirubin ≤1.5×ULN except in the presence of Gilbert's Syndrome where direct bilirubin should be ≤ULN 3. ANC ≥1.5×10^9/L 4. Platelets ≥100×10^9/L without transfusion support within 14 days prior to study treatment 5. Hemoglobin ≥9.0 g/dL without transfusion support within 14 days prior to study treatment 6. Calculated creatinine clearance ≥60 mL/min by Cockcroft-Gault formula or CKD-EPI 7. Coagulation tests ≤1.5×ULN unless subject is receiving anticoagulant therapy, as long as PT, INR, or aPTT is within the therapeutic range of intended use of anticoagulants
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Site 06 · Maumee, Ohio
- Site 02 · Portland, Oregon
- Site 04 · Fairfax, Virginia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07814248 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tubulin-inhibitor-based drug conjugate disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify