OncoMatch

OncoMatch/Clinical Trials/NCT07646106

THE-0504 in Patients With Solid Tumors

Is NCT07646106 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies THE-0504 for small cell lung cancer (sclc).

Phase 1RecruitingThena Biotech S.r.l.NCT07646106Data as of Jul 2026Location: Italy

Treatment: THE-0504Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.

Check if I qualify

Extracted eligibility criteria

Treatments studied

Other

THE-0504

Cancer type

Small Cell Lung Cancer

Colorectal Cancer

Gastric Cancer

Triple-Negative Breast Cancer

Breast Carcinoma

Pancreatic Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: EMA-approved treatment options

have exhausted all EMA-approved treatment options

Cannot have received: Top1 inhibitor

had not tolerated previously administered Top1 inhibitor treatments

Lab requirements

Blood counts

Hgb ≥ 9 g/dL; ANC ≥1.5x10^9/L; PLT≥100.0 x10^9/L

Kidney function

Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m2 according to the CKD-EPI formula

Liver function

Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis). Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor)

adequate liver function as assessed by following laboratory tests...; adequate kidney function as assessed by following laboratory test...; adequate bone marrow function as defined as...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07646106 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior Top1 inhibitor 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