Neoplasm Malignant Clinical Trial
Official title:
Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors
Primary Objective:
To determine the maximum tolerated dose (MTD) of SAR566658
Secondary Objectives:
- To characterize the safety profile of SAR566658
- To evaluate the pharmacokinetic profile of SAR566658
- To assess the potential immunogenicity of SAR566658
- To assess preliminary antitumor activity
- To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using
midazolam
- To assess safety in the alternative schedules of SAR566658 administration
The duration of the study for one patient in the dose escalation phase of the study will include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a 2-week treatment cycle(s). The patients may continue treatment until disease progression, unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. If a patient treated in dose escalation part or in an expansion cohorts, continues to benefit from the treatment at the time of Clinical Study Report, the patient can continue study treatment and will continue to undergo all assessments as per the study flowchart. Such patients will be followed at least until 30 days after the last IMP administration. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Completed |
NCT01930552 -
A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT01657214 -
Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
|
Phase 1 | |
Active, not recruiting |
NCT03911388 -
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
|
Phase 1 | |
Completed |
NCT02575781 -
A Study of SAR428926 in Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01943838 -
A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma
|
Phase 1 | |
Completed |
NCT03324113 -
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06238687 -
A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02435121 -
A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification
|
Phase 2 | |
Completed |
NCT01985191 -
A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients
|
Phase 1 | |
Completed |
NCT01455532 -
A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03491631 -
Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04067388 -
iKnife REIMS Project
|
||
Completed |
NCT01836705 -
Effect of SAR302503 on ECG Activity in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT01140607 -
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
|
Phase 1 | |
Recruiting |
NCT04495790 -
AIMS Cancer Outcomes Study
|
||
Recruiting |
NCT05714553 -
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
Recruiting |
NCT04733469 -
EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
|
N/A | |
Active, not recruiting |
NCT03845166 -
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
|
Phase 1 | |
Completed |
NCT01596270 -
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
|
Phase 1 |