IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Fortvita Biologics (USA)Inc.
Study ID
NCT06349408
Phase
PHASE1
Status
Recruiting
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Conditions

  • Locally Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • IBI3001 — DRUG
    The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)

Study Details

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Key Dates

First listed
Apr 5, 2024
Start date
Jan 10, 2025
Status verified
Sep 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Open-label: IBI3001 monotherapy

Primary Outcome Measure

Number of subjects with adverse events [ Time Frame: 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
START Center for Cancer ResearchLos AngelesCalifornia90025
Fortvita Biologics CT.gov Call Center
[email protected]
650-370-0985
START Center for Cancer ResearchEast BrunswickNew Jersey08816
Fortvita Biologics CT.gov Call Center
[email protected]
650-370-0985
NEXT OncologyDallasTexas75039
Fortvita Biologics CT.gov Call Center
[email protected]
650-370-0985
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By research site
START Center for Cancer Research· Los Angeles, CASTART Center for Cancer Research· East Brunswick, NJNEXT Oncology· Dallas, TXVirginia Cancer Specialists· Fairfax, VA

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