OncoMatch/Clinical Trials/NCT06234423
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
Is NCT06234423 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CUSP06 for ovarian cancer.
Treatment: CUSP06 — This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — standard of care
previously treated with standard of care systemic therapy, or for whom no standard therapy is available
Cannot have received: antibody-drug conjugate with topoisomerase I payload
Prior treatment with an ADC with a topoisomerase I (TOP1) payload
Cannot have received: allogeneic bone marrow transplantation
Prior allogeneic bone marrow transplantation
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L (1500/µL), without colony-stimulating factor support for the past 14 days; Platelets ≥100.0 x 10^9/L (100 000/µL); Hemoglobin ≥9.0 g/dL (without blood transfusion in 2-week period prior to screening)
Kidney function
Creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockcroft-Gault method
Liver function
Serum total bilirubin ≤ 1.5 x ULN; AST ≤2.5 x ULN; ALT ≤ 2.5 x ULN
Cardiac function
LVEF ≥50% as per ECHO or MUGA; QTc ≤480 ms (Fridericia's formula)
Adequate organ function as defined by: ANC ≥1.5 x 10^9/L (1500/µL), without colony-stimulating factor support for the past 14 days; Platelets ≥100.0 x 10^9/L (100 000/µL); Hemoglobin ≥9.0 g/dL (without blood transfusion in 2-week period prior to screening); Creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockcroft-Gault method; Serum total bilirubin ≤ 1.5 x ULN; AST ≤2.5 x ULN; ALT ≤ 2.5 x ULN; INR ≤ 1.5; aPTT ≤ 1.5 x ULN; LVEF ≥50% as per ECHO or MUGA; QTc ≤480 ms (Fridericia's formula); Baseline oxygen saturation on room air ≥ 92%; Albumin ≥ 3.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute at HealthONE · Denver, Colorado
- Yale University · New Haven, Connecticut
- Mount Sinai Medical Center · Miami Beach, Florida
- Florida Cancer Specialists · Sarasota, Florida
- Dana Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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