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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06234423 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate with topoisomerase I payload, allogeneic bone marrow transplantation 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 qualifyRelated pages