Actively Recruiting
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
Led by OnCusp Therapeutics, Inc. · Updated on 2026-01-14
263
Participants Needed
15
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any screening procedures
- Male or female patients aged 18 years or older at consent
- Have histologically or cytologically confirmed advanced solid tumors previously treated with standard therapy or no standard therapy available
- Willing to provide archival tumor tissue or undergo pretreatment biopsy if safe and feasible
- Have measurable disease according to RECIST version 1.1
- Have an ECOG performance status of 0 or 1 and life expectancy of at least 12 weeks
- Have adequate organ function as defined by specific blood counts, liver and kidney function tests, heart function, oxygen saturation, and albumin levels
- Women of childbearing potential must agree to use a highly effective contraceptive method
- Able and willing to sign informed consent and follow study visit schedule and protocol requirements
You will not qualify if you...
- Prior treatment with an antibody drug conjugate containing a topoisomerase I payload
- Active or progressing brain metastases or leptomeningeal disease; stable treated brain metastases allowed if stable for at least 2 months without symptoms
- Persistent toxicities greater than grade 1 from prior systemic antineoplastic treatments, except alopecia and vitiligo
- Systemic anti-cancer therapy or prohibited medications within 5 half-lives or 4 weeks before first dose
- Wide-field radiotherapy within 4 weeks or palliative focal radiation outside measurable disease within 2 weeks before first dose
- Major surgery within 4 weeks before first dose or not recovered from such surgery
- Clinically significant lung disease requiring systemic corticosteroids within 6 months or suspected by imaging
- Acute or chronic pancreatitis, liver cirrhosis except well compensated (Child-Pugh class A)
- Hepatic insufficiency with jaundice, encephalopathy, or variceal bleed within 60 days before study entry
- History of liver transplant or prior allogeneic bone marrow transplant
- Significant cardiac disease including recent myocardial infarction, heart failure class III/IV, uncontrolled hypertension or arrhythmias
- Thromboembolic or cerebrovascular events within 3 months before first dose
- Acute or significant infections including hepatitis B, C, or HIV unless controlled as defined
- Known or suspected allergy to study drug or components
- Concurrent participation in another investigational trial
- Pregnant or breastfeeding females
- History of other malignancies within 3 years except certain low-risk cancers
- Severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study
- Chest irradiation within 1 year prior to first dose
- Gastrointestinal obstruction within 4 weeks prior to first dose
- Live vaccination within 30 days prior to first dose
- Use of strong CYP3A4 or CYP1A2 inducers or inhibitors within 14 days prior or inability to discontinue
- Ascites requiring frequent paracentesis for symptom control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
4
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
NYU Cancer Institute Clinical Cancer Center
New York, New York, United States, 10016
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
9
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
NEXT Oncology
Houston, Texas, United States, 77054
Actively Recruiting
13
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
14
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Mater Cancer Care Centre
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
Research Team
P
Priya Marreddy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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