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NCT Number: NCT05941507

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 48 months

    Incidence and severity of AEs and SAEs

  2. 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

    Based on tolerability, preliminary anti tumor activity, and pharmacokinetics

  3. Objective Response Rate (Phase 2)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  4. Clinical Benefit Rate (Phase 2)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  5. Duration of Response (Phase 2)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  6. Time to Progression (Phase 2)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  7. Progression Free Survival (Phase 2)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  8. Overall Survival (Phase 2)

    Time frame: Up to 24 months

    Survival rates

Secondary outcomes

  1. Plasma Concentrations of LCB84 (Phase 1 and 2)

    Time frame: Up to 48 months

    Pharmacokinetic parameters will be determined from observed concentrations of LCB84

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

    Time frame: Up to 48 months

    Occurrence of ADA measured in serum at selected timepoints during the study

  3. Objective Response Rate (Phase 1)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  4. Duration of Response (Phase 1)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  5. Time to Progression (Phase 1)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

  6. Progression Free Survival (Phase 1)

    Time frame: Up to 24 months

    Assessed by RECIST 1.1, iRECIST, and RANO-BM

Study contacts

Contact information is provided by the study sponsor or research team.

David Browning

CONTACT

[email protected]

+1-615-975-7776

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Collaborators

  • AntibodyChem Biosciences, Inc.

Registry information

Official study title

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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