A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
General:
Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)
Life expectancy of greater than or equal to (\>/=) 3 months
Disease-free of active second/secondary or prior malignancies \>/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast
Adequate hematological, renal, hepatic and coagulation laboratory test results
Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug
Advanced Solid Malignancies:
Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy
Participants must be refractory or intolerant to standard therapy
NUT-midline carcinoma:
Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy
Diagnosis of one of the following is required:
1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or;
2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL
Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment
You may not be if
Participants must have measurable disease
Participants with hematologic malignancies
New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia
Have Fridericia-corrected QT interval (QTcF) greater than (\>) 470 milliseconds (msec) (female) or \> 450 (male), or history of congenital long QT syndrome
Active, uncontrolled bacterial, viral, or fungal infections
Known clinically important respiratory impairment
Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies
History of major organ transplant
History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry
Symptomatic central nervous system malignancy or metastasis
Pregnant or nursing
Treatment with surgery or chemotherapy within 28 days prior to study entry
Prior treatment with small molecule (BET) family inhibitor
Radiation for symptomatic lesions within 14 days of study enrollment
Clareo Health | A Two Part Study of RO6870810. Dose-Escalation Study in Participants With Advanced Solid Tumors and Expansion Study in Participants With Selected Malignancies
