Phase
Condition
Neoplasms
Treatment
EMB-02
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing and able to provide written informed consent.
Phase I: Patients with histologically or cytologically confirmed locallyadvanced/metastatic solid tumors and have failed (progressed on, or are intolerantof) standard therapies. Moreover, the disease should be measurable or evaluable perRECIST v1.1
Phase II Cohort A: Patients with histologically or cytologically confirmed locallyadvanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, includingprior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And thedisease is measurable or evaluable per RECIST v1.1
Archival tumor samples available for retrospective analysis or biopsy will be taken.
ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3Months
Adequate organ function to participate in the trial.
Recovery from adverse events (AEs) related to prior anticancer therapy.
Highly effective contraception
Exclusion
Exclusion Criteria:
Patients who have active autoimmune disease or history of autoimmune disease
History of severe irAE.
History of severe allergic reactions
Use of systemic corticosteroids.
Symptomatic central nervous system metastases.
Patients with cardiac dysfunction
Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
Prior treatment with a LAG-3 inhibitor
Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter)prior to study treatment;
Prior organ or stem cell/bone marrow transplant.
Concurrent malignancy < 5 years prior to entry.
Patients with active infections.
Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
Live virus vaccines < 30 days prior to screening
Pregnant or breast-feeding females
Any investigational agents or study drugs from a previous clinical study within 30days of the first dose of study treatment
Any other serious underlying medical conditions
Abuse on alcohol, cannabis- derived products or other drugs
Study Design
Study Description
Connect with a study center
Southern Medical Day Care Centre
Wollongong, New South Wales 2500
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Peninsula & South Eastern Haematology & Oncology Group (PASO)
Frankston, Victoria 3199
AustraliaSite Not Available
Beijing Cancer Hospital
Beijing, Beijing 100000
ChinaSite Not Available
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian
ChinaSite Not Available
HanDan Central Hospital
Handan, Hebei
ChinaSite Not Available
HeNan Provincial People's Hospital
Zhengzhou, Henan
ChinaSite Not Available
SuiNing Central Hospital
Suining, Sichuan
ChinaSite Not Available
University of Colorado Health Medical Group
Colorado Springs, Colorado 80909
United StatesSite Not Available
Prisma Health-Upstate
Greenville, South Carolina 29605
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.