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Advanced Solid TumorPhase 1NCT05621525

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

A Phase 1 study testing BBP-398 in people with Advanced Solid Tumor and Advanced or Metastatic Non-small Cell Lung Cancer, run by LianBio LLC at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
BBP-398
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesChina
Study dates
18 Oct 2022to 29 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong, 510060

Other trials in China

About this study

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

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.

Being tested
BBP-398
Keywords
Solid Tumors, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBP-398Drug

    Also called IACS-15509

    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.

Study groups in NCT05621525
Study groupRoleWhat they receive
Part A Dose Escalation and Part B Dose ExpansionExperimentalPart 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)
Receives: Drug: BBP-398

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The MTD will be based on DLT

    Measured: 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

    Measured: Completion of 1 Cycle (28 days)

Secondary outcomes (6)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start18 Oct 2022
  3. Primary completion29 Mar 2024
  4. Study completion29 Mar 2024

Why it stopped: Business reason

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621525
Sponsor's protocol ID
LB1002-101
Status last verified
Jun 2024
First submitted
10 Nov 2022
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBP-398 in people with Advanced Solid Tumor and Advanced or Metastatic Non-small Cell Lung Cancer, run by LianBio LLC at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reason). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of Maximum Tolerated Dose (MTD) of BBP-398 (time frame: Completion of 1 Cycle (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.

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