Solid Tumor Clinical Trial
Official title:
A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
This is a multicenter, open-label, dose-escalation study in subjects with advanced or
metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts
planning as following:
cohort 1: PEG-ENDO 1 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 2: PEG-ENDO
2mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1 cohort 3: PEG-ENDO 4 mg/kg+Docetaxel 75
mg/m2,once every 3 weeks at day 1 cohort 4: PEG-ENDO 6 mg/kg+Docetaxel75 mg/m2,once every 3
weeks at day 1 cohort 5: PEG-ENDO 8 mg/kg+Docetaxel75 mg/m2, once every 3 weeks at day 1
* Every 3 weeks as a treatment cycle. Subjects received only PEG-ENDO in the first cycle. For
second cycle or the higher, they received a combination therapy of PEG-ENDO and docetaxel.
Docetaxel was limited in 4 or 6 cycles。 The observation period of DLT was the 21 days after
the first administration of PEG-ENDO. During the observation period of DLT (cycle 1),
subjects only receive the corresponding dose of PEG-ENDO , for the second cycle and higher
,they will treated with the combination of PEG-ENDO and Docetaxel until disease progression
(PD) or intolerance . Docetaxel was limited in 4 or 6 cycles。
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
| Recruiting |
NCT05580991 -
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
| Recruiting |
NCT05159388 -
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
| Recruiting |
NCT06014502 -
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04107311 -
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
|
||
| Active, not recruiting |
NCT04078152 -
Durvalumab Long-Term Safety and Efficacy Study
|
Phase 4 | |
| Completed |
NCT02250157 -
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03943004 -
Trial of DFP-14927 in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
| Recruiting |
NCT05798546 -
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
|
Phase 1 | |
| Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT00479128 -
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04143789 -
Evaluation of AP-002 in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 |