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

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ClinicalTrials.gov Identifier: NCT05941507
Recruitment Status : Recruiting
First Posted : July 12, 2023
Last Update Posted : November 2, 2023
Sponsor:
Collaborator:
AntibodyChem Biosciences, Inc.
Information provided by (Responsible Party):
LegoChem Biosciences, Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: LCB84 Drug: Anti-PD-1 monoclonal antibody Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 5, 2023
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LCB84 monotherapy
IV infusion Q3W
 Drug: LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug
Experimental: LCB84 + anti-PD-1
IV infusion Q3W
 Drug: LCB84
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug

Drug: Anti-PD-1 monoclonal antibody
anti-PD-1 Ab


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05941507


Contacts
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Contact: David Browning +1-615-975-7776 dbrowning@legochembio.com

Locations
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United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Monica Mita, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Emily McClure, RN    857-215-0180    Emily_mcclure@dfci.harvard.edu   
Principal Investigator: Glen Hanna, MD         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Paul Swiecicki, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Douglas Orr, MD    972-566-3000    dorr@marycrowley.org   
Principal Investigator: Douglas Orr, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anjali Raina    713-792-3238    ARaina@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Philippe Bedard, MD         
Sponsors and Collaborators
LegoChem Biosciences, Inc
AntibodyChem Biosciences, Inc.
Investigators
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Study Director: Jennifer Wheler, MD AntibodyChem Biosciences
More Information
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Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT05941507    
Other Study ID Numbers: LCB84-1001
First Posted: July 12, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LegoChem Biosciences, Inc:
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
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs