Osteosarcoma Clinical Trial
Official title:
A Phase I/II, Multi-center, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of ALMB-0168 in Patients With Osteosarcoma
This is a phase I / II, multi-center, single-arm, open-label study to evaluate the safety and efficacy of ALMB-0168 in patients with osteosarcoma whose prior standard treatment have failed.
This is a phase I / II, multi-centre, single-arm, open-label study with two parts, a dose-escalation phase (Part I) and a dose-expansion phase (part II). In part I, patients with osteosarcoma whose prior standard treatment have failed will be assigned to receive sequentially higher doses of ALMB-0168 intravenously. The dose-escalation initially will follow an accelerated titration design for the first two dosing groups, then follow a classic 3+3 design. The maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALMB-0168 will be determined in part I. In Part II, 1-3 expansion cohorts will begin to further assess the safety profile and explore efficacy, and each cohort will enroll up to 60 patients with high-grade osteosarcoma in each cohort. All patients will receive multiple administration of ALMB-0168 until either the disease progresses or intolerable toxicity occurs. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00026780 -
Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
|
||
| Not yet recruiting |
NCT05515068 -
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
|
||
| Completed |
NCT02383901 -
A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX
|
N/A | |
| Active, not recruiting |
NCT01758666 -
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
|
N/A | |
| Completed |
NCT01674101 -
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy
|
N/A | |
| Completed |
NCT01615640 -
Diffusion Study on Patients With Osteosarcoma
|
||
| Completed |
NCT00520936 -
A Study of Pemetrexed in Children With Recurrent Cancer
|
Phase 2 | |
| Completed |
NCT00523419 -
Chemotherapy for Patients With Osteosarcoma
|
Phase 2 | |
| Completed |
NCT00132158 -
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT04319874 -
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
|
Phase 2 | |
| Recruiting |
NCT06029218 -
Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
|
N/A | |
| Recruiting |
NCT05642455 -
SPEARHEAD-3 Pediatric Study
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06117878 -
Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma
|
Early Phase 1 | |
| Not yet recruiting |
NCT04316091 -
A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma
|
Phase 1 | |
| Recruiting |
NCT03932058 -
Proteomics Research of Osteosarcoma
|
||
| Withdrawn |
NCT01236586 -
RO4929097 in Children With Relapsed/Refractory Solid or CNS Tumors, Lymphoma, or T-Cell Leukemia
|
Phase 1 | |
| Completed |
NCT00743496 -
A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
|
Phase 1 | |
| Recruiting |
NCT04040205 -
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
|
Phase 2 | |
| Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03628209 -
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
|
Phase 1/Phase 2 |