A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors.

Clinical Trial Description

This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410, a Trop-2 directed antibody-drug conjugate (ADC), in participants with previously treated, advanced solid tumors. The study comprises 2 parts: a Phase 1 Dose Escalation and a Phase 2 Dose Expansion. The Phase 1 will investigate the safety and tolerability of PBI-410 and identify one or more recommended doses for expansion (RDEs) and the maximum-tolerated dose (MTD) (if one exists). Phase 2 will investigate the preliminary efficacy of PBI-410 in signal-finding expansion cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06384807
Study type	Interventional
Source	Biohaven Pharmaceuticals, Inc.
Contact	Chief Medical Officer
Phone	203-404-0410
Email	clinicaltrials@biohavenpharma.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 22, 2024
Completion date	February 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05691608` - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2	N/A
Recruiting	`NCT05580991` - Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors	Phase 1
Active, not recruiting	`NCT02846038` - Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
Recruiting	`NCT05159388` - A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors	Phase 1/Phase 2
Completed	`NCT03181854` - Randomized Controlled Trial of Integrated Early Palliative Care	N/A
Recruiting	`NCT06014502` - Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors	Phase 1
Recruiting	`NCT05981703` - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT04107311` - Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Active, not recruiting	`NCT04078152` - Durvalumab Long-Term Safety and Efficacy Study	Phase 4
Completed	`NCT02250157` - A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies	Phase 1
Recruiting	`NCT05566574` - A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer	Phase 1/Phase 2
Recruiting	`NCT03943004` - Trial of DFP-14927 in Advanced Solid Tumors	Phase 1
Recruiting	`NCT06036836` - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)	Phase 2
Recruiting	`NCT05798546` - Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)	Phase 1
Recruiting	`NCT05525858` - KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
Terminated	`NCT04586335` - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.	Phase 1
Active, not recruiting	`NCT00479128` - Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors	Phase 1
Recruiting	`NCT04143789` - Evaluation of AP-002 in Patients With Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT04550663` - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors	Phase 1
Completed	`NCT03980041` - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)	Phase 2