Clinical Trials Logo
  1. Home
  2. Advanced Solid Tumor
  3. NCT05101096

Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors — ASCENT-J02  

Advanced Solid Tumor Clinical Trial

Official title:
A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)

Clinical Trial Summary

The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors. Phase 2: Evaluate the safety and efficacy of SG in Japanese participants with metastatic triple-negative breast cancer (mTNBC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and metastatic urothelial cancer (mUC).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05101096
Study type Interventional
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230 (GILEAD-0)
Email GileadClinicalTrials@gilead.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 20, 2021
Completion date May 2026
View Details
See also
  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
Completed NCT05508100 - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors Phase 1
Not yet recruiting NCT05515185 - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors Early 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 NCT04890613 - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation 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