Advanced Solid Tumor Clinical Trial
Official title:
An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.
This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in participants with advanced tumors. The trial is composed of two parts, Part I and Part II. Part I is a dose escalation part to determine the MTD and/or RD of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection . Part II is a dose expansion part at RD level SIM1811-03 determined in Part I to assess the anti-tumor activity of SIM1811-03 or SIM1811-03 in combination with Sintilimab Injection in participants with advanced solid tumors or CTCL. The tumor types in Part II will be adjusted based on the response observed in Part I. ;
| 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 |
NCT06007482 -
A Study of ES009 in Subjects With Locally Advanced or Metastatic 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 | |
| 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 |
NCT05461287 -
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
|
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 |
NCT05443126 -
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
|
Phase 1/Phase 2 |