Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Circle Pharma
Study ID
NCT06577987
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CID-078 Monotherapy — DRUG
    Cyclin A/B-RxL inhibitor, twice-a-day in repeating 21-day treatment cycles until disease progression or discontinuation criteria.

Study Details

This is a first-in-human, multicenter, open-label, phase 1 study to evaluate safety, tolerability, and efficacy of CID-078, a Cyclin A/B-RxL inhibitor, in patients with advanced solid tumors.

Key Dates

Start date
Aug 14, 2024
Status verified
May 2025
Primary completion
Jan 14, 2027
Completion
Mar 14, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a Dose Escalation, Part 1b New Formulation/Pilot Food Effect and Part 2 Dose Expansion

Primary Outcome Measure

Part 1: Incidence of Treatment Emergent Adverse Events (TEAEs) based on CTCAE v5.0. [ Time Frame: From first dose of CID-078 on Cycle 0 Day 1/ Cycle 1 Day 1 (each cycle is 21 days) to 28 days after the last dose of study drug. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
Dana Farber Cancer InstituteBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49546-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
UH Seidman Cancer CenterClevelandOhio44106-
Oregon Health and Science UniversityPortlandOregon97239-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
START MountainWest Valley CityUtah84119-

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Florida Cancer Specialists· Sarasota, FLDana Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MIComprehensive Cancer Centers of Nevada· Las Vegas, NVUH Seidman Cancer Center· Cleveland, OHOregon Health and Science University· Portland, OR

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