Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05621525|
Recruitment Status : Recruiting
First Posted : November 18, 2022
Last Update Posted : December 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor Advanced or Metastatic Non-small Cell Lung Cancer||Drug: BBP-398||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
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
- Determination of Maximum Tolerated Dose (MTD) of BBP-398 [ Time Frame: Completion of 1 Cycle (28 days) ]The MTD will be based on DLT
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
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
|Contact: Lei Mu, Master||+86-021-23081188||Lei.firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guanzhou, Guangdong, China, 510060|
|Contact: Li Zhang, Master +86-020-87343458 email@example.com|
|West China Hospital Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Yongsheng Wang, Doctor 18980602258 firstname.lastname@example.org|
|Principal Investigator:||Li Zhang, Master||West China Hospital|
|Principal Investigator:||Yongsheng Wang, Doctor||West China Hospital|