A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
NCT ID: NCT05315180
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2021-08-24
2023-07-31
Brief Summary
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Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dose exploration
Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort
BPI-421286
Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
dose expansion
dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently
BPI-421286
Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
Interventions
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BPI-421286
Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
Eligibility Criteria
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Inclusion Criteria
* Standard treatment is not available or patient declines
* Adequate organ function
Exclusion Criteria
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
* Other protocol specified criteria
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shun Lu, Ph.D
Shanghai, Shanghai Municipality, China
Dingzhi Huang, Ph.D
Tianjin, Tianjin Municipality, China
Wen Li, Ph.D
Hangzhou, Zhejiang, China
Yun Fan,Ph.D
Hangzhou, Zhejiang, China
Shun Lu, Ph.D
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BTP-661311
Identifier Type: -
Identifier Source: org_study_id
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