Ovarian CancerPhase 1NCT06234423
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
A Phase 1 study testing CUSP06 in people with Ovarian Cancer and Solid Tumor, run by OnCusp Therapeutics, Inc. at 15 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Solid Tumor
- What is being tested?
- CUSP06
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 9 Feb 2024to 31 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
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- 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 a highly effective contraceptive method
- Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- 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 stereotactic radiosurgery, stable on baseline screening study MRI brain for at least 2 months (compared to comparator MRI brain) and asymptomatic without requirement for steroids or antiseizure medications.
- 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.
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- 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 radiation pneumonitis) or who are suspected to have such diseases by imaging at screening period.
- 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 York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe aortic stenosis.
- 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 additional conditions:
- 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 malignancies with low risk of recurrence may also be considered following discussion with the Medical Monitor.
- 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 interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for enrollment in this study.
- 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 the study.
- Ascites requiring frequent paracentesis for symptomatic management.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Elizabeth K Lee, MD
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Gerald Falchook, MD, MS
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
Alex Spira, MD
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Nehal Lakhani, MD, PhD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Funda Meric-Bernstam, MD
- Recruiting
NEXT Oncology
Houston, Texas, 77054
Jennifer Segar, MD
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Brian Slomovitz, MD
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Vivek Subbiah, MD
- Recruiting
Yale University
New Haven, Connecticut, 06520
Patricia LoRusso, DO
- Recruiting
NYU Cancer Institute Clinical Cancer Center
New York, New York, 10016
Bhavana Pothuri, M.D.
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Roisin O'Cearbhaill, MD
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Debra Richardson, MD
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Drew Rasco, MD
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Manish Patel, MD
Australia1 site, 1 recruiting
- Recruiting
Mater Cancer Care Centre
South Brisbane, Queensland, 4101
Catherine Shannon, MD
About this study
Official title: A Phase 1, First-in-Human Study of CUSP06, a Cadherin-6 (CDH6)-Directed Antibody-Drug Conjugate, in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
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
- Ovarian Cancer, Solid Tumor
- Being tested
- CUSP06
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSP06Drug
Antibody drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| Exploratory Cohort 1 | Experimental | Not described Receives: Drug: CUSP06 |
| Expansion Cohort 1 | Experimental | Not described Receives: Drug: CUSP06 |
| Expansion Cohort 2 | Experimental | Not described Receives: Drug: CUSP06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b)
Type, incidence, and severity of adverse events (AEs) and serious adverse events (SAEs) using the NCI CTCAE v.5.0.
Frequency and duration of dose interruptions and reductions.
Measured: 36 months
Determine the recommended dose for expansion (RDE) of CUSP06 (Phase 1a)
Measured: 15 months
Evaluate preliminary efficacy of CUSP06 as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1b)
ORR: proportion of patients achieving a best overall response of confirmed partial or complete response (PR+CR)
Measured: 16 months
Secondary outcomes (13)
Evaluate the pharmacokinetic (PK) profile of CUSP06 - maximum concentration (Cmax) (Phase 1a and 1b)
Measured: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - time to Cmax (Tmax) (Phase 1a and 1b)
Measured: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - area under the curve (AUC) (Phase 1a and 1b)
Measured: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - terminal half-life (t1/2) (Phase 1a and 1b)
Measured: 36 months
Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a)
ORR is defined as proportion of patients achieving a best overall response of confirmed partial or complete response (PR+CR)
Measured: 18 months
Disease control rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
DCR is defined as disease control rate based on best overall response.
Measured: 36 months
Clinical benefit rate (CBR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
CBR is defined as proportion of subjects achieving a best overall response of confirmed partial or complete response, or durable stable disease.
Measured: 36 months
Duration of response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
DoR is defined as time from the date of the first documented CR/PR until first documentation of disease progression or death, whichever comes first.
Measured: 36 months
Time to progression (TTP) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Measured: 36 months
Progression free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
PFS is defined as time from the date of the first dose to the date of the first documentation of disease progression or death, whichever comes first.
Measured: 36 months
Overall survival (OS) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
OS is defined time from the first dose date to the date of death from any cause.
Measured: 42 months
For PROC patients: proportion of patients with a change from baseline CA-125 level ≥50% for at least 28 days (Phase 1a and 1b)
Measured: 36 months
Evaluate the immunogenicity of CUSP06 (Phase 1a and 1b)
Assessment of antidrug antibodies (ADAs)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start9 Feb 2024
- Primary completion30 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OnCusp Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234423
- Sponsor's protocol ID
- CUSP06-1001
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study of CUSP06, a Cadherin-6 (CDH6)-Directed Antibody-Drug Conjugate, in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06234423
- Acronym / sponsor ID
- CUSP06-1001
- Conditions
- Ovarian Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- OnCusp Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exploratory Cohort 1 | Experimental | Drug: CUSP06 |
| Expansion Cohort 1 | Experimental | Drug: CUSP06 |
| Expansion Cohort 2 | Experimental | Drug: CUSP06 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (30 listed)
- 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 stereotactic radiosurgery, stable on baseline screening study MRI brain for at least 2 months (compared to comparator MRI brain) and asymptomatic without requirement for steroids or antiseizure medications.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUSP06Antibody drug conjugate (ADC) | Drug | Expansion Cohort 1, Expansion Cohort 2, Exploratory Cohort 1 |
Primary outcome
Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b)
Time frame: 36 months
Type, incidence, and severity of adverse events (AEs) and serious adverse events (SAEs) using the NCI CTCAE v.5.0. Frequency and duration of dose interruptions and reductions.
Determine the recommended dose for expansion (RDE) of CUSP06 (Phase 1a)
Time frame: 15 months
Evaluate preliminary efficacy of CUSP06 as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1b)
Time frame: 16 months
ORR: proportion of patients achieving a best overall response of confirmed partial or complete response (PR+CR)
13 secondary outcomes
Evaluate the pharmacokinetic (PK) profile of CUSP06 - maximum concentration (Cmax) (Phase 1a and 1b)
Time frame: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - time to Cmax (Tmax) (Phase 1a and 1b)
Time frame: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - area under the curve (AUC) (Phase 1a and 1b)
Time frame: 36 months
Evaluate the pharmacokinetic (PK) profile of CUSP06 - terminal half-life (t1/2) (Phase 1a and 1b)
Time frame: 36 months
Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a)
Time frame: 18 months
Disease control rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 36 months
Clinical benefit rate (CBR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 36 months
Duration of response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 36 months
Time to progression (TTP) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 36 months
Progression free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 36 months
Overall survival (OS) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a and 1b)
Time frame: 42 months
For PROC patients: proportion of patients with a change from baseline CA-125 level ≥50% for at least 28 days (Phase 1a and 1b)
Time frame: 36 months
Evaluate the immunogenicity of CUSP06 (Phase 1a and 1b)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CUSP06 in people with Ovarian Cancer and Solid Tumor, run by OnCusp Therapeutics, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priya Marreddy ((610)256-5979, Priya.Marreddy@oncusptx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b) (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.