Clinical trial NCT05621525: Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Advanced or Metastatic Non-small Cell Lung Cancer
Keywords: Solid Tumors, NSCLC
Lead sponsor: LianBio LLC
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Determination of Maximum Tolerated Dose (MTD) of BBP-398
timeFrame: Completion of 1 Cycle (28 days)
measure: Determination of anti-tumor activity of BBP-398
timeFrame: Completion of 1 Cycle (28 days)
Secondary outcomes:
measure: Part A:Maximum plasma concentration (Cmax) of BBP-398
timeFrame: Approximately 6 months
measure: Part A:Time to reach Cmax (Tmax) of BBP-398
timeFrame: Approximately 6 months
measure: Part A: Terminal half-life (t1/2) of BBP-398
timeFrame: Approximately 6months
measure: Part A: Area under the plasma concentration-time curve (AUC) of BBP-398
timeFrame: Approximately 6 months
measure: Part A: Concentration of BBP-398 in urine
timeFrame: Approximately 6 months
measure: Part B: Concentration of BBP-398 in plasma
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Li Zhang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Yongsheng Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: