NCT06234423

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_1 ovarian-cancer

Timeline
17mo left

Started Feb 2024

Typical duration for phase_1 ovarian-cancer

Geographic Reach
2 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Feb 2024Oct 2027

First Submitted

Initial submission to the registry

January 10, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 9, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

January 14, 2026

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

January 10, 2024

Last Update Submit

January 12, 2026

Conditions

Ovarian CancerSolid Tumor

Outcome Measures

Primary Outcomes (3)

  • 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.

    36 months

  • Determine the recommended dose for expansion (RDE) of CUSP06 (Phase 1a)

    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)

    16 months

Secondary Outcomes (13)

  • Evaluate the pharmacokinetic (PK) profile of CUSP06 - maximum concentration (Cmax) (Phase 1a and 1b)

    36 months

  • Evaluate the pharmacokinetic (PK) profile of CUSP06 - time to Cmax (Tmax) (Phase 1a and 1b)

    36 months

  • Evaluate the pharmacokinetic (PK) profile of CUSP06 - area under the curve (AUC) (Phase 1a and 1b)

    36 months

  • Evaluate the pharmacokinetic (PK) profile of CUSP06 - terminal half-life (t1/2) (Phase 1a and 1b)

    36 months

  • Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Phase 1a)

    18 months

  • +8 more secondary outcomes

Study Arms (3)

Exploratory Cohort 1

EXPERIMENTAL
Drug: CUSP06

Expansion Cohort 1

EXPERIMENTAL
Drug: CUSP06

Expansion Cohort 2

EXPERIMENTAL
Drug: CUSP06

Interventions

CUSP06DRUG

Antibody drug conjugate (ADC)

Expansion Cohort 1Expansion Cohort 2Exploratory Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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).
  • +5 more criteria

You may not qualify 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 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.
  • 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:
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NYU Cancer Institute Clinical Cancer Center

New York, New York, 10016, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

Houston, Texas, 77054, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Mater Cancer Care Centre

South Brisbane, Queensland, 4101, Australia

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Priya Marreddy

CONTACT

(610)256-5979Priya.Marreddy@oncusptx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 31, 2024

Study Start

February 9, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

January 14, 2026

Record last verified: 2025-10

Locations

AU(1)US(14)