Advanced Malignant Solid Tumors Clinical Trial
Official title:
Study Title A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-295S1 in Treatment of the Patients With Advanced Malignant Solid Tumors
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-295S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor. It will be extended to enroll 10-15 patients at this dose after RP2D is determined, as to further evaluate the safety of RP2D and the preliminary efficacy of HMPL-295S1. In addition, an exploratory study on the pharmacokinetic biomarkers of HMPL-295S1 is planned in this study.
This study is expected to enroll 52-87 patients, including 30-60 patients for dose escalation, the enrollment will continue until about 12 patients in the dose group with response, as to determine RP2D (assuming the two dose groups will continue enrollment to 12 patients), additional 10-15 patients will be enrolled at the dose level of determined RP2D. The number of patients finally screened in the study will depend on the number of dose levels evaluated, occurrence of dose-limiting toxicity (DLT) in each dose group and the failure rate of screening. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00728468 -
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
|
Phase 1 | |
| Completed |
NCT00445458 -
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00768469 -
Study Evaluating Safety And Tolerability, Solid Tumor
|
Phase 1 | |
| Recruiting |
NCT04226066 -
Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06464055 -
A Study of GQ1010 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06231550 -
A Study of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT05383703 -
Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor
|
Phase 1 | |
| Recruiting |
NCT05773937 -
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
|
Phase 1 | |
| Completed |
NCT04328506 -
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05886374 -
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Completed |
NCT00958724 -
Study Evaluating Neratinib In Combination With Vinorelbine In Subjects With Advanced Or Metastatic Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT05949775 -
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
|
N/A | |
| Terminated |
NCT02045095 -
A Dose Escalation Study of MLN7243 (TAK-243) in Adult Participants With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00884845 -
Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05277454 -
Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
|
Phase 1 | |
| Active, not recruiting |
NCT03792958 -
Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT00997360 -
Study of PKI-179 Administered Orally to Subjects With Solid Tumors
|
Phase 1 | |
| Completed |
NCT04126668 -
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05338957 -
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03047811 -
The Study of Targeted NY-ESO-1 T Cell Receptor (TCR) Genetic Modified Autologous T Cells Treatment of Advanced Solid Tumors
|
N/A |