CClinicalTrials.gg
Sign In
Status unknownNCT05302843Updated Mar 31, 2022

A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

A Phase 1 interventional study of BPI-28592 in Metastasis, Neoplasm, sponsored by Betta Pharmaceuticals Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Betta Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2021, registered Mar 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors

02

Conditions studied

  • Metastasis, Neoplasm

Browse trials for

Keywords

  • NTRK1/2/3, fusion
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 40 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Betta Pharmaceuticals Co., Ltd. is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
  • At least 18 years of age
  • Measurable or evaluable disease
  • Adequate organ function as defined per protocol

Exclusion criteria

Exclusion Criteria:

  • Symptomatic or unstable brain metastases
  • Pregnancy or lactation
  • Other protocol specified criteria
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    dose exploration and dose expansion

    Patients receive BPI-28592 PO. Cycles repeat every 28 days.

    Drug: BPI-28592

Interventions

  • DrugBPI-28592

    Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592

06

What researchers measure

Primary outcomes

  1. Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies

    Number of subjects with treatment related adverse events

    Time frame: about 20 months

  2. determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen

    Number of subjects with dose limiting toxicity

    Time frame: about 20 months

Secondary outcomes

  1. Evaluate the pharmacokinetics of BPI-28592

    Blood plasma concentration

    Time frame: about 20 months

  2. To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592

    Evaluate clinical activity/efficacy of BPI-28592

    Time frame: about 20 months

  3. To evaluate the duration of response (DOR) in subjects with CR or PR as best response

    Evaluate clinical activity/efficacy of BPI-28592

    Time frame: about 20 months

  4. to evaluate the disease control rate (DCR)

    Evaluate clinical activity/efficacy of BPI-28592

    Time frame: about 20 months

  5. To evaluate progression-free survival (PFS) following initiation of BPI-28592

    Evaluate clinical activity/efficacy of BPI-28592

    Time frame: about 20 months

  6. To evaluate overall (OS) following initiation of BPI-28592

    Evaluate clinical activity/efficacy of BPI-28592

    Time frame: about 20 months

07

Study locations

1 of 1 sites recruiting
  • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
    HangZhou, Zhejiang, China
    • Hongming Pan, Ph.D · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05302843
Lead sponsor
Betta Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Mar 22, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 31, 2022

Study contacts

Hongming Pan, Ph.D
Contact
shonco@sina.cn
0571-86006922

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasm Metastasis→

Other studies from this sponsor

Betta Pharmaceuticals Co., Ltd.

Start the discussion