Phase 1a/1b BGB-290 for Advanced Solid Tumors.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in participants with advanced solid tumors.
Full description
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the PK of BGB 290 in participants with advanced solid tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
- Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
- BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Adequate bone marrow, liver, and renal function.
- Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
- Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
- Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and throughout the study until 28 days after the last investigational product administration.
- Able to swallow and retain oral medication.
Key Exclusion Criteria:
- Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
- Participants who are not considered to be refractory to platinum-based therapy (e.g., progressive disease at the first tumor assessment while receiving platinum treatment).
- Participants who have not been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within five times half-lives of the last treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy).
- Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
- Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
- Participants who have not received therapeutic radiotherapy to target lesions. 7.Participants who have received local palliative radiotherapy of non-target lesions for local symptom control within the last 21 days must have recovered from any adverse effects of radiotherapy before recording screening symptoms. 8.No untreated brain metastasis or unstable neurologic condition after the completion of radiation, or requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the symptoms.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
101 participants in 5 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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