A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
LigaChem Biosciences, Inc.
Study ID
NCT05941507
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • LCB84 — DRUG
    TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
  • Anti-PD-1 monoclonal antibody — DRUG
    anti-PD-1 Ab

Study Details

This is a first-in-human, Phase 1/2 study to evaluate LCB84, a TROP2-directed antibody-drug conjugate, alone and in combination with an anti-PD-1 Ab, in dose escalation (Phase 1) followed by dose expansion (Phase 2). The study population in dose escalation (Phase 1) consists of patients with advanced solid tumors refractory to standard of care, or for whom no standard of care exists. After the MTD and/or RP2D for single agent LCB84 is determined, dose escalation cohorts with select tumor types will be enrolled. Combination LCB84 and anti-PD-1 Ab will be evaluated in dose escalation after a minimum of 2 dose levels of single agent LCB84 have established DLT safety, to determine the MTD and/or RP2D of combination LCB84 and anti-PD-1 Ab, and to continue into dose expansion cohorts in select tumor types.

Key Dates

Start date
Oct 5, 2023
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LCB84 monotherapy
    IV infusion Q3W
  • Experimental: LCB84 + anti-PD-1
    IV infusion Q3W

Primary Outcome Measure

Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2) [ Time Frame: Up to 48 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Yuan Yuan, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
DFCI External Referral
[email protected]
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Cancer Answer Line
[email protected]
1-800-865-1125
Paul Swiecicki, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Jeff Russell, M.D. (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Douglas Orr, MD
[email protected]
972-566-3000
Douglas Orr, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Heather McArthur, M.D. (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Anjali Raina
[email protected]
713-792-3238
Funda Meric-Bernstam, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CADana Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MITennessee Oncology· Nashville, TNMary Crowley Cancer Research· Dallas, TXUniversity of Texas Southwestern Medical Center· Dallas, TX

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