Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1, Multicenter, Open-label, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of HY-0102 administered intravenously (IV) once every two weeks in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of HY-0102 and obtain the preliminary efficacy information of patients with advanced solid tumors.
This is a Phase I trial to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HY-0102 administered intravenously (IV) once every two weeks in adult patients with locally advanced/metastatic malignant solid tumors (urothelial carcinoma, colorectal and pancreatic cancers, etc). Three dosing cohorts are planned with the doses of 5, 10 and 15 mg/kg. The study will apply a standard 3+3 dose escalation design in dose escalation.Dose expansion will enroll approximately 30-40 cases of tumor types that have demonstrated preliminary efficacy in the early escalation phase. The number of enrolled patients is estimated to be up to 50. The dose limiting toxicity evaluation period will be the first 28 days (Cycle 1) and subsequent cycles will be 4 weeks in duration. Patients will receive the investigational drug on Day 1 of cycle 1 followed by 28 days of observation. HY-0102 will be administered IV once every two weeks for Cycle 2 and beyond. ;
| 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 |
NCT06054932 -
Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06008366 -
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| 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 |
NCT05443126 -
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
|
Phase 1/Phase 2 | |
| 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 |