A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
OnCusp Therapeutics, Inc.
Study ID
NCT06234423
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CUSP06 — DRUG
    Antibody drug conjugate (ADC)

Study Details

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.

Key Dates

Start date
Feb 9, 2024
Status verified
Oct 2025
Primary completion
May 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
263 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Exploratory Cohort 1
  • Experimental: Expansion Cohort 1
  • Experimental: Expansion Cohort 2

Primary Outcome Measure

Characterize the safety and tolerability of CUSP06 (Phase 1a and 1b) [ Time Frame: 36 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Gerald Falchook, MD, MS
Yale UniversityNew HavenConnecticut06520
Patricia LoRusso, DO (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical CenterMiami BeachFlorida33140
Brian Slomovitz, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Manish Patel, MD
Dana Farber Cancer InstituteBostonMassachusetts02115
Elizabeth K Lee, MD
START MidwestGrand RapidsMichigan49546
Nehal Lakhani, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Roisin O'Cearbhaill, MD (PRINCIPAL_INVESTIGATOR)
NYU Cancer Institute Clinical Cancer CenterNew YorkNew York10016
Bhavana Pothuri, M.D.
Stephenson Cancer CenterOklahoma CityOklahoma73104
Debra Richardson, MD
SCRI Oncology PartnersNashvilleTennessee37203
Vivek Subbiah, MD
MD Anderson Cancer CenterHoustonTexas77030
Funda Meric-Bernstam, MD
NEXT OncologyHoustonTexas77054
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
START San AntonioSan AntonioTexas78229
Drew Rasco, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyFairfaxVirginia22031
Alex Spira, MD

Find similar trials in Denver, CO

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Sarah Cannon Research Institute at HealthONE· Denver, COYale University· New Haven, CTMount Sinai Medical Center· Miami Beach, FLFlorida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MI

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