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TerminatedNCT05621525Updated Jun 25, 2024

Phase I Study of the BBP-398 in Patients With Advance Solid Tumors

A Phase 1 interventional study of BBP-398 in Advanced Solid Tumor and Advanced or Metastatic Non-small Cell Lung Cancer, sponsored by LianBio LLC. Terminated at 2 sites in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by LianBio LLC · Phase 1, Interventional, and Treatment

Why this study was terminated
Business reason
Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

This is an open label, dose escalation and expansion, two-part Phase I study for SHP-2 inhibitor BBP-398 to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and preliminary anti- cancer activity in Chinese subjects with advanced solid tumors and in Chinese subjects with advanced or metastatic EGFR-mutant NSCLC.

Read the detailed description

The Part A of this phase I trial is an abbreviated dose escalation study of BBP-398 following the USA mono dose escalation study (Study NAV- 1001, clinicaltrials.gov ID NCT04528836). The purpose of this part is to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity in Chinese subjects with advanced solid tumors. The Part B of this study is to explore the safety, tolerability and efficacy of BBP-398 in Chinese subjects with advanced or metastatic EGFR- mutant NSCLC at MTD and/or RP2D. This Phase I study will provide supportive data to enable Chinese patients to join the combo dose escalation and expansion studies and/or other clinical trials of BBP-398.

02

Conditions studied

  • Advanced Solid Tumor
  • Advanced or Metastatic Non-small Cell Lung Cancer

Keywords

  • Solid Tumors, NSCLC
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

LianBio LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients must have the ability to understand and the willingness to sign a written informed consent document 2 Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures 3. Age ≥18, male or female 4.Dose escalation: locally advanced or metastatic solid tumors Dose expansion: Advanced or metastatic EGFR-mutant NSCLC 5. Patients must have measurable disease by RECIST v1.1. 6. Patients must have an ECOG performance status (PS) ≤2 7.Patients with a life expectancy of ≥12 weeks. 8. Patients must have adequate organ function

Exclusion criteria

Exclusion Criteria:

  1. Patients with a known additional malignancy that is progressing or requires active treatment
  2. Patients who have previously received a SHP-2 inhibitor
  3. Patients who are hypersensitivity to SHP-2 inhibitor or any ingredients
  4. Treatment with any of the related anti-cancer therapies prior to the first dose of BBP-398 within the stated timeframes
  5. Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.
  6. Patients with any of the cardiac-related issues or findings
  7. Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.
  8. Patients with known central nervous system (CNS) tumors
  9. Patients with known active CNS metastases and/or carcinomatous meningitis.
  10. Patients with persisting toxicity related to prior therapy.
  11. Patients who have undergone major surgery within 4 weeks prior to study enrollment.
  12. Pregnant or breastfeeding female patients.
  13. Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.
05

Study design

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

Study arms

  • Experimental
    Part A Dose Escalation and Part B Dose Expansion

    Part A: Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD). Part B: Oral capsules administered at MTD/RP2D defined dose. Each treatment cycle will be 28 days in duration with BBP-398 administered, once daily (QD)

    Drug: BBP-398

Interventions

  • DrugBBP-398

    BBP-398 (formerly known as IACS-15509) is a potent, selective, orally active allosteric inhibitor of SHP2, a tyrosine phosphatase that plays a key role in the RTK -MAPK signal transduction pathway. Key components of the MAPK pathway include the small GTPase RAS, the serine/threonine-protein kinase RAF, mitogen-activated protein kinase (MEK) and ERK. In cells, SHP2 binds to phosphorylated tyrosine residues in the intracellular domain of RTKs such as the EGFR, leading to activation of the downstream MAPK signaling pathway.

    Also known as: IACS-15509

06

What researchers measure

Primary outcomes

  1. Determination of Maximum Tolerated Dose (MTD) of BBP-398

    The MTD will be based on DLT

    Time frame: Completion of 1 Cycle (28 days)

  2. Determination of anti-tumor activity of BBP-398

    Anti-tumor activity will be defined by objective response rate (ORR, complete response + partial response rate) and duration of response (DOR) according to RECIST v1.1

    Time frame: Completion of 1 Cycle (28 days)

Secondary outcomes

  1. Part A:Maximum plasma concentration (Cmax) of BBP-398

    Maximum plasma concentration of BBP-398 after single and multiple dose administration of BBP-398

    Time frame: Approximately 6 months

  2. Part A:Time to reach Cmax (Tmax) of BBP-398

    The amount of time to reach Cmax after single and multiple dose administration of BBP-398

    Time frame: Approximately 6 months

  3. Part A: Terminal half-life (t1/2) of BBP-398

    Terminal half-life (t1/2) after single and multiple dose administration of BBP-398

    Time frame: Approximately 6months

  4. Part A: Area under the plasma concentration-time curve (AUC) of BBP-398

    Area under the plasma concentration versus time curve after single and multiple dose administration of BBP-398

    Time frame: Approximately 6 months

  5. Part A: Concentration of BBP-398 in urine

    To evaluate BBP-398 excretion via urine after single and multiple dose administration of BBP-398.

    Time frame: Approximately 6 months

  6. Part B: Concentration of BBP-398 in plasma

    To evaluate BBP-398 plasma concentration after multiple dose administration of BBP-398.

    Time frame: Approximately 6 months

07

Study locations

2 sites
  • Sun Yat-sen University Cancer Center
    Guanzhou, Guangdong 510060, China
  • West China Hospital Sichuan University
    Chengdu, Sichuan 610041, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05621525
Lead sponsor
LianBio LLC
Responsible party
Sponsor
First posted
Nov 18, 2022
Start date
Oct 18, 2022
Primary completion
Mar 29, 2024
Completion
Mar 29, 2024
Last update
Jun 25, 2024

Study contacts

Li Zhang, Master
principal investigator · West China Hospital
Yongsheng Wang, Doctor
principal investigator · West China Hospital

Oversight

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

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