Recruiting
Phase 1
Phase 2

LCB84 & Anti-PD-1 Ab

Sponsor:

LigaChem Biosciences, Inc.

Code:

NCT05941507

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LCB84

Anti-PD-1 monoclonal antibody

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Study ID

NCT05941507

Start date

Oct 5, 2023

Status verified date

Sep, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.
  • Phase 2 Dose Expansion\*: select histologically or cytologically confirmed advanced solid tumors refractory to standard of care treatment.

\*expansion cohort indications to be prioritized based on data from Phase 1 dose escalation.
  • Prior treatment with TROP2-directed therapy is permitted.
  • Measurable disease as defined by RECIST v1.1 or RANO-BM.
  • Willingness to provide archival tumor tissue when available or to undergo pre-treatment biopsy if not available.
  • Mandatory pre- and on-treatment biopsies for enrichment cohorts in Phase 1 dose escalation and Phase 2 expansion cohorts if deemed medically feasible and safe.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function as defined by:

  • Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days
  • Platelets ≥100.0 x 109/L (100 000/µL)
  • Hemoglobin ≥9.0 g/dL
  • Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases present)

Key Exclusion Criteria:

  • Active or progressing central nervous system (CNS) metastases or any evidence of leptomeningeal disease.

Note: Patients with stable or treated CNS metastases may be eligible if all of the following criteria are met: 1) localized treatment for brain metastases completed at least 4 weeks prior to the first dose of study drug 2) no new or progressive neurologic symptoms and without need for immediate local therapy, steroids or anticonvulsants for symptom control (stable or decreasing steroid dose (a stable dose of ≤4 mg dexamethasone oral or equivalent) is permitted) 3) stable brain metastases for at least 1 month prior to screening (baseline) brain MRI.

  • Persistent toxicities from previous systemic antineoplastic treatments >Grade 1, excluding alopecia and vitiligo.
  • Systemic antineoplastic therapy (including antiestrogen therapy) within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug.
  • Concomitant use of systemic steroids at dose of >10 mg of prednisone or its equivalent per day (exception for brain metastases, as described in exclusion criteria #1 above).

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LCB84 monotherapy

IV infusion Q3W

experimental: LCB84 + anti-PD-1

IV infusion Q3W

Interventions

LCB84

TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug

Anti-PD-1 monoclonal antibody

anti-PD-1 Ab

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 ]
  • Recommended Phase 2 Dose of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1) [ Time Frame: Up to 24 months ]
  • Objective Response Rate (Phase 2) [ Time Frame: Up to 24 months ]
  • Clinical Benefit Rate (Phase 2) [ Time Frame: Up to 24 months ]
  • Duration of Response (Phase 2) [ Time Frame: Up to 24 months ]
  • Time to Progression (Phase 2) [ Time Frame: Up to 24 months ]
  • Progression Free Survival (Phase 2) [ Time Frame: Up to 24 months ]
  • Overall Survival (Phase 2) [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

David Browning

+1-615-975-7776dbrowning@ligachembio.com

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Yuan Yuan, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

DFCI External Referral

dfcicctiexternalreferral@dfci.harvard.edu

Principal Investigator:

Glenn Hanna, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer Answer Line

1-800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Paul Swiecicki, MD

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

Douglas Orr, MD

972-566-3000dorr@marycrowley.org

Principal Investigator:

Douglas Orr, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Anjali Raina

713-792-3238ARaina@mdanderson.org

Principal Investigator:

Funda Meric-Bernstam, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416 946 4501 x 4737virtuoso@uhn.ca

Principal Investigator:

Philippe Bedard, MD

More Information

Sponsor

LigaChem Biosciences, Inc.

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • TROP2
  • TROP-2
  • Breast Cancer
  • Head and Neck Cancer
  • TNBC
  • Gastric Cancer
  • Gastroesophageal
  • NSCLC
  • Lung Cancer
  • Glioblastoma
  • Endometrial Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Anal Cancer
  • Pancreatic Cancer
  • Urothelial Cancer
  • HNSCC
  • Salivary gland cancer
  • LCB84

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LigaChem Biosciences, Inc. on 2025-09-24.