Advanced Solid Tumor Clinical Trial
Official title:
Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.
CX-5461 (Pidnarulex), a synthetically-derived small molecule that selectively kills HR-deficient cancer cells through the binding and stabilization of G4 DNA structure. Early phase 1 studies suggest CX-5461 has activity and warrants further investigation in HR-deficient tumors. This study aims to determine the tolerable dose of CX-5461 for phase II studies, amongst an expansion cohorts of BRCA1/2, PALB2 or HRD mutant tumors. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05515185 -
B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors
|
Early Phase 1 | |
| Completed |
NCT05508100 -
Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT02836600 -
A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04390737 -
Evaluate the Safety and Clinical Activity of HH2853
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06007482 -
A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT04108676 -
Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects
|
Phase 1 | |
| Recruiting |
NCT05798611 -
Study of ART0380 in Patients With Biologically Selected Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT05076396 -
PM14 Administered Intravenously to Patients With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06008366 -
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06054932 -
Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04825392 -
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06365918 -
Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis
|
Phase 1 | |
| Recruiting |
NCT05569057 -
A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05461287 -
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05443126 -
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04592653 -
Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)
|
Phase 1/Phase 2 |