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New treatment option for Ovarian Cancer
Official title A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06234423
What this study is testing
What is CUSP06?
CUSP06 is an investigational medicine, being studied as a potential treatment for ovarian 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 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.
- 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
- Written informed consent provided prior to any screening procedures.
- Male or female patients, ≥18 years of age at the time of obtaining informed consent.
- Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom...
- Willingness to provide archival tumor tissue, when available. If no archival tissue is available, willingness to undergo a pretreatment biopsy if...
- Measurable disease per RECIST v1.1.
You likely can't join if
- Prior treatment with an ADC with a topoisomerase I (TOP1) payload.
- Active or progressing brain metastases or evidence of leptomeningeal disease. Stable/treated brain metastases are permitted (defined as history of...
- Persistent toxicities from previous systemic antineoplastic treatments of Grade \>1, excluding alopecia and vitiligo.
- Systemic antineoplastic therapy or prohibited co-medications within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study...
- Wide-field radiotherapy (e.g., \>30% of marrow-bearing bones) within 4 weeks, or focal radiation with palliative intent outside the field of...
- Major surgery within 4 weeks prior to first dose of study drug, or no recovery from side effects of such intervention.
See the full eligibility criteria
Who can join
- Written informed consent provided prior to any screening procedures.
- Male or female patients, ≥18 years of age at the time of obtaining informed consent.
- Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom no standard therapy is available.
- Willingness to provide archival tumor tissue, when available. If no archival tissue is available, willingness to undergo a pretreatment biopsy if medically feasible and safe.
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of ≥12 weeks.
- Adequate organ function as defined by:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days.
- Platelets ≥100.0 x 109/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 the upper limit of normal (ULN).
- Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Left ventricular ejection fraction (LVEF) ≥50% as per echocardiography (ECHO) or multi-gated acquisition scan (MUGA).
- Q wave to T wave (QT) interval corrected for heart rate (QTc) ≤480 ms (Fridericia's formula).
- Baseline oxygen saturation on room air ≥ 92%
- Albumin ≥ 3.0 g/dL
- Women of child-bearing potential (WOCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use...
- Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
What rules you out
- Prior treatment with an ADC with a topoisomerase I (TOP1) payload.
- Active or progressing brain metastases or evidence of leptomeningeal disease. Stable/treated brain metastases are permitted (defined as history of brain metastases previously treated with surgical resection or...
- Persistent toxicities from previous systemic antineoplastic treatments of Grade \>1, excluding alopecia and vitiligo.
- Systemic antineoplastic therapy or prohibited co-medications within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug, including investigational agents.
- Wide-field radiotherapy (e.g., \>30% of marrow-bearing bones) within 4 weeks, or focal radiation with palliative intent outside the field of measurable disease within 2 weeks prior to first dose of the study drug.
- Major surgery within 4 weeks prior to first dose of study drug, or no recovery from side effects of such intervention.
- Has had clinically significant lung disease requiring systemic corticosteroid treatment within the last 6 months of randomization/registration (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe...
- Patients with acute or chronic pancreatitis and/or liver cirrhosis except well compensated cirrhosis (Child-Pugh class A).
- Hepatic insufficiency manifesting as clinical jaundice, hepatic encephalopathy, and/or variceal bleed within 60 days prior to study entry.
- History of liver transplant.
- Prior allogeneic bone marrow transplantation.
- Significant cardiac disease, such as recent (within 6 months prior to first dose of the study drug) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New...
- History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within 3 months prior to first dose of the study drug.
- Acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
- Note: patients with chronic HBV, HCV or HIV infection will be eligible if they are considered upon a mutual agreement of the Investigator and the Medical Monitor as safe for enrollment and meet one of the following...
- Patients with HIV infection are on an established antiretroviral therapy for at least 4 weeks, and have CD4+ T-cell counts ≥350 cells/µL and HIV viral load \<50 copies/mL,
- Patients with serologic evidence of chronic HBV infection receive concurrent anti-HBV therapy and have HBV viral load below the limit of quantification,
- Patients with a history of HCV infection must have completed curative anti-HCV therapy and have HCV viral load below the limit of quantification,
- Patients on concurrent anti-HCV therapy have HCV viral load below the limit of quantification.
- Known or suspected allergy to the study drug or any component of the study drug.
- Concurrent participation in another investigational clinical trial.
- Pregnant or breast-feeding females.
- Prior history of malignancy other than inclusion diagnosis within 3 years prior to first dose of the study drug.
- Note: excluding patients with adequately treated basal cell or squamous cell skin cancer, non-invasive superficial bladder cancer, in situ cervical cancer, in situ breast cancer, and in situ prostate cancer. Other...
- Any other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study drug administration or may interfere with the...
- Chest irradiation within 1 year prior to first dose of study drug.
- Gastrointestinal obstruction or radiographic evidence of gastrointestinal obstruction within 4 weeks prior to the first dose of study drug.
- Vaccination with a live vaccine ≤30 days prior to first dose of study drug.
- Use of a strong cytochrome P450 (CYP)3A4 or CYP1A2 inducer or inhibitor ≤14 days prior to first dose of study drug or inability to discontinue use of a strong CYP3A4 or CYP1A2 inducer or inhibitor for the duration of...
- Ascites requiring frequent paracentesis for symptomatic management.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Miami Beach, Florida, United States
- Sarasota, Florida, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- South Brisbane, Queensland, Australia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Denver, Colorado, United States; New Haven, Connecticut, United States; Miami Beach, Florida, United States; Sarasota, Florida, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.