Trial Title:
A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors
NCT ID:
NCT05941507
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Antibodies
Antibodies, Monoclonal
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LCB84
Description:
TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE)
prodrug
Arm group label:
LCB84 + anti-PD-1
Arm group label:
LCB84 monotherapy
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
anti-PD-1 Ab
Arm group label:
LCB84 + anti-PD-1
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.
Criteria for eligibility:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Yuan Yuan, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
DFCI External Referral
Email:
dfcicctiexternalreferral@dfci.harvard.edu
Investigator:
Last name:
Glenn Hanna, MD
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer Line
Phone:
800-865-1125
Email:
CancerAnswerLine@med.umich.edu
Investigator:
Last name:
Paul Swiecicki, MD
Email:
Principal Investigator
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Orr, MD
Phone:
972-566-3000
Email:
dorr@marycrowley.org
Investigator:
Last name:
Douglas Orr, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anjali Raina
Phone:
713-792-3238
Email:
ARaina@mdanderson.org
Investigator:
Last name:
Funda Meric-Bernstam, MD
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
416 946 4501 x 4737
Email:
virtuoso@uhn.ca
Investigator:
Last name:
Philippe Bedard, MD
Email:
Principal Investigator
Start date:
October 5, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
LigaChem Biosciences, Inc.
Agency class:
Industry
Collaborator:
Agency:
AntibodyChem Biosciences, Inc.
Agency class:
Other
Source:
LigaChem Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941507
