Phase
Condition
Neoplasms
Treatment
CLN-418
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willingness to sign a written informed consent document.
Male or female subject aged ≥18 years old at the time of screening.
Histologically or cytologically confirmed advanced solid tumors (e.g., breastcancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-smallcell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelialcarcinoma, head and neck squamous cell carcinoma (HNSCC)), followed bydose-expansion cohorts (Part 2) of subjects with advanced and/or metastaticnon-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).orrecurrent and progressed since last antitumor therapy for which no alternative,curative standard therapy exists.
Adequate organ and bone marrow function.
Exclusion
Exclusion Criteria:
Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.
Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior tofirst dose of investigational product, any other anti-cancer therapy within 2 weeksprior to first dose of investigational product.
Not yet recovered from surgery or (immune-related) toxicity related with previoustreatment.
Known history or active infection of hepatitis B or C.
History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related,autoimmune hepatitis.
Known brain metastases or other central nervous system metastases that are eithersymptomatic or untreated that require concurrent treatment.
Active infection that requires treatment with antibiotics or antiviral treatmentwithin 3 weeks prior to first dose of investigational product.
Known history of infection with human immunodeficiency virus or known acquiredimmunodeficiency syndrome (AIDS).
Known autoimmune disease.
Clinically significant cardiac condition.
Pregnant or breastfeeding women.
Study Design
Study Description
Connect with a study center
St George Private Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Southern Medical Day Care Centre
Wollongong, New South Wales 2500
AustraliaSite Not Available
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesSite Not Available
Carolina BioOncology Institute - Cancer Research Centre
Huntersville, North Carolina 28078
United StatesSite Not Available
MD Anderson
Houston, Texas 77030
United StatesSite Not Available
NEXT Oncology
Irving, Texas 75039
United StatesSite Not Available
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