This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Zumutor Biologics Inc.
Study ID
NCT06451497
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ZM008 — BIOLOGICAL
    Intravenous delivery

Study Details

This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.

Key Dates

Start date
May 22, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Single arm dosing with ZM008 and in combination with Toripalimab
    Dose escalation of ZM008 alone and in combination with Toripalimab.

Primary Outcome Measure

Nature and frequency of dose limiting toxicities per Common Toxicity Criteria for Adverse Events version 5 [ Time Frame: This starts at the beginning of screening procedures and upto 90 days after completion of the last cycle of investigational product administration with each cycle of 21 days duration. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna, MD
617-632-6799
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyAustin, TX 78758Texas78758
Andrae Vandross, MD
210-580-9500
Andrae Vandros, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Ildefonso Rivera, MD
210-580-9500
Ildefonso IR Rivera, MD (PRINCIPAL_INVESTIGATOR)

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