Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Clinical Trial of the Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors
Open label, single- and multiple-dose administration, dose-exploratory clinical phase I study to evaluate the safety, tolerability and PK profile of HX301 monolactate capsules in patients with advanced malignant solid tumors and to preliminarily evaluate its antitumor efficacy.
The study is divided into a screening period (28 days before first dose), treatment period (1 year) , and survival follow-up period. In the dose escalation stage,the study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects sequentially at escalating doses. The dose escalation phase includes a single-dose phase and a multiple-dose phase. Subjects in the single-dose phase were treated with HX301 monolactate, taken orally before breakfast , and in the multiple-dose phase, the frequency of administration was once daily (QD), 3 weeks continuously, suspended for 1 week, and every 4 weeks (28 days) was a dosing cycle. Dose escalation will continue until identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment until 28 days .Blood samples will be collected at regular intervals for pharmacokinetics (PK). The Tumor evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1] to assess efficacy will start from the first dose and occur every 8 weeks in the first 24 weeks and every 12 weeks thereafter.. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04972981 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05086822 -
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03260322 -
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05862831 -
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03641794 -
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT03665129 -
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05914116 -
A Study of DB-1311 in Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01693562 -
A Phase 1/2 Study to Evaluate MEDI4736
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04387916 -
A Study of KC1036 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04095273 -
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
|
Phase 1 | |
| Not yet recruiting |
NCT03692520 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02997176 -
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
|
Phase 1 | |
| Recruiting |
NCT04446260 -
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02253992 -
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06076291 -
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03545971 -
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT00962091 -
Study of MLN8237 in Participants With Advanced Solid Tumors
|
Phase 1 |