Study in Advanced Solid Tumor Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Callio Therapeutics
Study ID
NCT07300943
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • CLIO-8221 — DRUG
    intravenous (IV) infusion

Study Details

The study will be conducted in 2 phases: Phase 1: Dose-escalation and Dose Level Expansion, Phase 1 will determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). Phase 2: Tumor-Specific Expansions with Dose Optimization, Phase 2 will further evaluate CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy.

Key Dates

Start date
Mar 19, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jul 17, 2028

Study Design

Enrollment
306 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation and dose level expansion
    Phase 1: CLIO-8221 monotherapy in escalating doses. Phase 2: Phase 2 will be initiated in tumor-specific expansion cohorts at selected doses.

Primary Outcome Measure

Type, incidence, severity, and seriousness of adverse events (AEs) [ Time Frame: Through end of treatment, up to approximately 2 years. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
DFCIBostonMassachusetts02215-5450-
Sarah Cannon Research Institute 335 24th Avenue North, Suite 400NashvilleTennessee37203
SCRI Patient Intake Team
[email protected]
615-329-7640
Dr. Hamilton (Erika Paige Hamilton) (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Desirae Dufner, Dr
[email protected]
713-745-7813
START San AntonioSan AntonioTexas78229-
START MountainWest Valley CityUtah84119-

Find similar trials in Boston, MA

By research site
DFCI· Boston, MASarah Cannon Research Institute 335 24th Avenue North, Suite 400· Nashville, TNMD Anderson Cancer Center· Houston, TXSTART San Antonio· San Antonio, TXSTART Mountain· West Valley City, UT

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