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A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor

NCT03791112 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-01-27

No results posted yet for this study

Summary

This was an open-label Phase I study. The primary objective of the study was to assess safety, tolerability, efficacy, and pharmacokinetic characteristics of BPI-16350 in different dose groups.

Conditions

  • Advanced Solid Cancer

Interventions

DRUG

BPI-16350

BPI-16350 capsules administered orally

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791112 on ClinicalTrials.gov