NCT02361723

Phase 1a/1b BGB-290 for Advanced Solid Tumors.

A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment

Interventions

Type	Name	Description
DRUG	BGB-290
DRUG	BGB-290
DRUG	BGB-290
DRUG	BGB-290
DRUG	BGB-290

Timeline

• Start date: 2014-07-03
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2015-02-12
• Last updated: 2024-12-27

Locations

7 sites across 1 country: Australia