Clinical Trials Logo

Clinical Trial Summary

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.


Clinical Trial Description

The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04528836
Study type Interventional
Source Navire Pharma Inc., a BridgeBio company
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 12, 2020
Completion date February 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05637034 - 68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer N/A
Terminated NCT04095091 - Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
Recruiting NCT05378425 - A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab Phase 1
Not yet recruiting NCT04723810 - TumorGlow Intraoperative Molecular Imaging (IMI) Phase 1/Phase 2
Recruiting NCT06116032 - Immune Profiling for Cancer Immunotherapy Response
Recruiting NCT06090266 - A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT04416165 - Comparison of FDG and FAPI in Patients With Various Types of Cancer N/A
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT04750772 - Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer N/A
Recruiting NCT06022029 - A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. Phase 1
Terminated NCT01358331 - A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001) Phase 1
Recruiting NCT06175221 - Autologous TLPO Vaccine Basket Phase 2
Recruiting NCT05661461 - Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment Phase 1
Active, not recruiting NCT04196530 - BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab Phase 1
Not yet recruiting NCT03731390 - GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma Phase 1
Active, not recruiting NCT03491631 - Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06193902 - LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. Phase 1/Phase 2
Recruiting NCT05221320 - Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies Phase 2
Not yet recruiting NCT04367948 - Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma N/A