Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calithera Biosciences, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
(Part 1)
Documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to standard therapies of proven clinical benefit.
(Part 2) Meets 1 of the 3 defined cohorts:
Cohort 1: Documented incurable/locally advanced or metastatic ccRCC
Cohort 2: Documented incurable/locally advanced or metastatic defined as ER, PR negative (\<1%) and HER2 negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[FISH\] negative)
Cohort 3: incurable/locally advanced or metastatic CRC
For both Parts 1 \& 2:
Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 from toxicities related to the prior therapy
Adequate renal, hepatic, and hematological function
Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 evaluable disease (Part 1) or measurable disease (Part 2)
Ability to provide written consent in accordance with federal, local and institutional guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
You may not be if
Prior treatment with CB-839 or a PARP inhibitor
Unable to received oral medications
Active and/or untreated central nervous system metastasis. Patients with treated brain metastases must have (1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline central nervous system (CNS) imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
Major surgery within 28 days prior to first dose of study drug
