Phase
Condition
Head And Neck Cancer
Neoplasms
Treatment
BGB-30813
Tislelizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Phase 1a (Dose Escalation):
Participants with histologically or cytologically confirmed advanced,metastatic, and unresectable solid tumors who have previously receivedavailable standard systemic therapy or for whom treatment is not available ornot tolerated and who have not received any prior therapy targetingdiacylglycerol kinase (DGK)
Eligible tumor types are immune sensitive solid tumors such as non-small celllung cancer (NSCLC), head neck squamous cell cancer (HNSCC), small cell lungcancer, hepatocellular carcinoma, esophageal cancer, gastric orgastroesophageal carcinoma, nasopharyngeal carcinoma, triple-negative breastcancer, urothelial carcinoma, renal cell carcinoma, cervical cancer,endometrial carcinoma, cutaneous squamous cell carcinoma, melanoma, Merkel cellcarcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutationburden (TMB)-high, or mismatch repair deficient solid tumors
Prior checkpoint inhibitor (CPI) therapy is allowed
Phase 1b (Dose Expansion):
Participants with selected advanced or metastatic solid tumors including NSCLC,HNSCC, and additional potential tumor types to be defined based on emergingdata
≥ 1 measurable lesion per RECIST v1.1
Eastern Cooperative Group Oncology Performance (ECOG) Performance Status score ≤ 1
Females of childbearing potential must be willing to use a highly effective methodof birth control for the duration of the study
Adequate organ function as indicated by the following laboratory values up to firstdose of study treatment: Hemoglobin≥ 90 grams per liter (g/L), Absolute neutrophilcount ≥ 1.5 x 109/L , Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (< 3x ULN for participants with Gilbert syndrome ), aspartate aminotransferase (AST) andalanine aminotransferase (ALT) ≤ 2.5 x ULN
Exclusion
Exclusion Criteria:
Previous therapy targeting DGK
Active leptomeningeal disease or uncontrolled symptomatic central nervous system (CNS) metastasis
Active autoimmune diseases or history of autoimmune diseases that may relapse
Any active malignancy ≤ 2 years before the first dose of study treatment except forthe specific cancer under investigation in this study and any locally recurringcancer that has been treated with curative intent
Systemic anticancer therapy, including chemotherapy ≤ 21 days or 5 half-lives (whichever is shorter) before the first dose of study drugs
≥ Grade 3 immune-mediated adverse events on prior immuno-oncology agent (anti-PD-1or anti-CTLA4 antibodies or other experimental drugs)
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne 2158177, Victoria 2145234 3000
AustraliaSite Not Available
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
Linear Clinical Research
Nedlands 2064874, Western Australia 2058645 6009
AustraliaSite Not Available
Jinan Central Hospital
Jinan, Shandong 250013
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaSite Not Available
Shandong Provincial Hospital
Jinan, Shandong 250021
ChinaSite Not Available
Jinan Central Hospital
Jinan 1805753, Shandong 1796328 250013
ChinaSite Not Available
Shandong Cancer Hospital
Jinan 1805753, Shandong 1796328 250117
ChinaSite Not Available
Shandong Provincial Hospital
Jinan 1805753, Shandong 1796328 250021
ChinaSite Not Available
Hospital Universitario Vall Dhebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Vall Dhebron
Barcelona 3128760, 08035
SpainSite Not Available
Start Madrid Fundacion Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Start Madrid Fundacion Jimenez Diaz
Madrid 3117735, 28040
SpainSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601-1915
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601-1915
United StatesSite Not Available
Md Anderson Cancer Center
Houston, Texas 77030-3907
United StatesSite Not Available
Next Oncology
San Antonio, Texas 78229-6028
United StatesSite Not Available
Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030-3907
United StatesSite Not Available
Next Oncology
San Antonio 4726206, Texas 4736286 78229-6028
United StatesSite Not Available

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