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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05621525
Recruitment Status : Recruiting
First Posted : November 18, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
LianBio LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Advanced or Metastatic Non-small Cell Lung Cancer Drug: BBP-398 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation and Expansion, Two- Part Study of SHP-2 Inhibitor BBP-398 to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-cancer Activity in Chinese Subjects With Advanced Solid Tumors
Actual Study Start Date : October 18, 2022
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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.
Other Name: IACS-15509


Outcome Measures
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Primary Outcome Measures :
  1. Determination of Maximum Tolerated Dose (MTD) of BBP-398 [ Time Frame: Completion of 1 Cycle (28 days) ]
    The MTD will be based on DLT

  2. Determination of anti-tumor activity of BBP-398 [ Time Frame: Completion of 1 Cycle (28 days) ]
    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


Secondary Outcome Measures :
  1. Part A:Maximum plasma concentration (Cmax) of BBP-398 [ Time Frame: Approximately 6 months ]
    Maximum plasma concentration of BBP-398 after single and multiple dose administration of BBP-398

  2. Part A:Time to reach Cmax (Tmax) of BBP-398 [ Time Frame: Approximately 6 months ]
    The amount of time to reach Cmax after single and multiple dose administration of BBP-398

  3. Part A: Terminal half-life (t1/2) of BBP-398 [ Time Frame: Approximately 6months ]
    Terminal half-life (t1/2) after single and multiple dose administration of BBP-398

  4. Part A: Area under the plasma concentration-time curve (AUC) of BBP-398 [ Time Frame: Approximately 6 months ]
    Area under the plasma concentration versus time curve after single and multiple dose administration of BBP-398

  5. Part A: Concentration of BBP-398 in urine [ Time Frame: Approximately 6 months ]
    To evaluate BBP-398 excretion via urine after single and multiple dose administration of BBP-398.

  6. Part B: Concentration of BBP-398 in plasma [ Time Frame: Approximately 6 months ]
    To evaluate BBP-398 plasma concentration after multiple dose administration of BBP-398.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05621525


Contacts
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Contact: Lei Mu, Master +86-021-23081188 Lei.mu@lianbio.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guanzhou, Guangdong, China, 510060
Contact: Li Zhang, Master    +86-020-87343458    zhangli@sysucc.org.cn   
China, Sichuan
West China Hospital Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Yongsheng Wang, Doctor    18980602258    wangy756@163.com   
Sponsors and Collaborators
LianBio LLC
Investigators
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Principal Investigator: Li Zhang, Master West China Hospital
Principal Investigator: Yongsheng Wang, Doctor West China Hospital
More Information
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Responsible Party: LianBio LLC
ClinicalTrials.gov Identifier: NCT05621525    
Other Study ID Numbers: LB1002-101
First Posted: November 18, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LianBio LLC:
Solid Tumors, NSCLC
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases