Patient case: 50-year-old male with pancreatic cancer; genetic feature: BRCA2

Clinical trial: Study of the Safety and Pharmacokinetics of BGB-290 in Subjects With Advanced Solid Tumors

Summary: This study is designed to evaluate the safety, tolerability and PK profile and treatment Effect of BGB-290 in Chinese advanced cancer subjects.


Eligibility: -  Inclusion Criteria:
  1. Subjects have voluntarily agreed to participate by giving written informed consent.
  2. Age 18-75 years (including 18 and 75 years) on the day of signing informed consent.
  3. Subjects have advanced or metastasis tumor who have experienced disease progression after at least one-line chemotherapy and meet the following eligibility criteria for the corresponding part of the study:
  1. In Dose Escalation:
  1. The subjects must have a histologically or cytologically confirmed advanced or metastatic triple negative breast cancer (TNBC), high-grade epithelial, non-mucinous, ovarian cancer, fallopian cancer, or primary peritoneal cancer for which no effective standard therapy is available.
  2. BRCA1 and BRCA2 mutations are not required but enrichment of this subject population is preferred.
  3. Subjects must agree to retrospective germline BRCA testing using blood samples
  4. Archival tumor tissues are strongly recommended to be collected if available.
  2. In Dose Expansion:
  1. Subjects who have histologically or cytologically confirmed advanced or metastatic cancer as described below, and have progressed after receiving at least one prior chemotherapy regimen in the advanced or metastatic setting could be recruited to one of the two expansion arms
  2. Arm 1. Subjects with high-grade epithelial, non-mucinous, ovarian cancer, fallopian cancer, or primary peritoneal caner harboring germline BRCA1/2 or somatic BRCA1/2 mutation
  3. Arm 2. Subjects with triple negative breast cancer harboring germline BRCA1/2 or somatic BRCA1/2 mutation
  4. Subjects must agree to germline BRCA testing using blood samples for pre-screening or confirmation
  5. Archival tumor tissues are strongly recommended to be collected if available. For subjects with somatic BRCA1/2 mutation, archival tumor tissue or fresh tumor biopsy is mandatory 4. Subjects must have at least one measurable disease as defined per the RECIST V1.1.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  6. Life expectancy ≥ 12 weeks.
  7. Subject must have adequate organ function
  8. Female subjects are eligible to enter and participate in the study if they are of non-childbearing potential or childbearing potential, has a negative serum pregnancy test at screening
  9. Male subjects are eligible to enter and participate in the study if they are vasectomized or agree to use of contraception during the study treatment period and for at least 180 days after the last dose of the study drug.
  -  Exclusion Criteria:
  1. Subjects who were treated with chemotherapy, biologic therapy, immunotherapy or any investigational therapies, if eligible, must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter, but no less than 3 weeks) before the study drug administration, and all AEs have either returned to baseline or stabilized.
  2. Subjects who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit. subjects must have recovered from the treatment and have a stable clinical condition before entering this study
  3. Subjects who have undergone radiotherapy for any cause within 4 weeks of screening visit. subjects must have recovered from the treatment and have a stable clinical condition before entering this study .
  4. Untreated leptomeningeal or brain metastasis.
  5. Prior therapies targeting PARP
  6. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation.
  7. Acute myocardial infarction and unstable angina, stroke, or transient ischemic attack; Subjects suffering from below heart disease:
  1. QTcF >480 msec on screening ECG
  2. Right bundle branch block + left anterior hemiblock or complete left bundle branch block
  3. Congenital long QT syndrome or family history of unexpected sudden cardiac death
  4. History or presence of ventricular tachyarrhythmia
  5. Clinically significant resting bradycardia (< 50 bpm)
  6. Obligate use of cardiac pacemaker
  7. g. Other clinically significant heart disease

Relevance to patient case: not relevant