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

NCT05941507 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LCB84-1001
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 8

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

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

Outcome Measures

Primary Outcomes (8)

• Safety of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1 and 2)

  Incidence and severity of AEs and SAEs

  Up to 48 months

• Recommended Phase 2 Dose of LCB84 alone and LCB84 in combination with an anti-PD-1 Ab (Phase 1)

  Based on tolerability, preliminary anti tumor activity, and pharmacokinetics

  Up to 24 months

• Objective Response Rate (Phase 2)

  Assessed by RECIST 1.1, iRECIST, and RANO-BM

  Up to 24 months

• Clinical Benefit Rate (Phase 2)

  Assessed by RECIST 1.1, iRECIST, and RANO-BM

  Up to 24 months

• Duration of Response (Phase 2)

  Assessed by RECIST 1.1, iRECIST, and RANO-BM

  Up to 24 months

• Time to Progression (Phase 2)

  Assessed by RECIST 1.1, iRECIST, and RANO-BM

  Up to 24 months

• Progression Free Survival (Phase 2)

  Assessed by RECIST 1.1, iRECIST, and RANO-BM

  Up to 24 months

• Overall Survival (Phase 2)

  Survival rates

  Up to 24 months

Secondary Outcomes (6)

• Plasma Concentrations of LCB84 (Phase 1 and 2)

  Up to 48 months

• Evaluation of the immunogenicity of LCB84 (Phase 1 and 2)

  Up to 48 months

• Objective Response Rate (Phase 1)

  Up to 24 months

• Duration of Response (Phase 1)

  Up to 24 months

• Time to Progression (Phase 1)

  Up to 24 months

Study Arms (2)

LCB84 monotherapy

EXPERIMENTAL

IV infusion Q3W

Drug: LCB84

LCB84 + anti-PD-1

EXPERIMENTAL

IV infusion Q3W

Drug: LCB84; Drug: Anti-PD-1 monoclonal antibody

Interventions

LCB84 DRUG

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

LCB84 + anti-PD-1; LCB84 monotherapy

Anti-PD-1 monoclonal antibody DRUG

anti-PD-1 Ab

LCB84 + anti-PD-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• LigaChem Biosciences, Inc.: lead
• AntibodyChem Biosciences, Inc.: collaborator

Study Sites (8)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Stomach Neoplasms; Lung Neoplasms; Glioblastoma; Endometrial Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Anus Neoplasms; Pancreatic Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Anus Diseases; Rectal Diseases; Pancreatic Diseases; Carcinoma, Squamous Cell; Carcinoma; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Rodrigo Ruiz-Soto, MD

  AntibodyChem Biosciences

  STUDY DIRECTOR

Central Study Contacts

David Browning

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (1)