Advanced Malignancies Clinical Trial
Official title:
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.
This study is composed of two stages:Part I is mono-therapy dose escalation and dose expansion study, and Part II is the study of combination therapy. The dose escalation study will be conducted using Part I for testing optimal doses at 0.3,1, 3, 10, 20, 30 mg/kg every 3 weeks (Q3W). An accelerated titration followed by traditional 3+3 design will be used in this study with a 21-day dose-limiting toxicity (DLT) observation period. Based on the data of dose escalation study, determine whether to carry out dose escalation at frequency of every 2 weeks(Q2W) and how many cohorts will be added in dose expansion study. Based on the data of Part I, one or two doses will be conducted in the study of combination therapy. The study of PART II is composed of two cohorts. Cohort 1:Subjects with untreated CLDN18.2 positive gastric/gastroesophageal junction adenocarcinoma(G/GEJAC) will be treated with MIL93 and standard first-line chemotherapy.Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Completed |
NCT00948961 -
A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
|
Phase 1/Phase 2 | |
| Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
| Terminated |
NCT02265510 -
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03907969 -
A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.
|
Phase 1/Phase 2 | |
| Completed |
NCT03241173 -
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT02923349 -
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT04025957 -
A Study of SHR-1501 in Patients With Advanced Tumors
|
Phase 1 | |
| Recruiting |
NCT05048134 -
A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00651664 -
A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Participants With Advanced Malignancies
|
Phase 1 | |
| Not yet recruiting |
NCT06038058 -
A Phase I Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00611793 -
PTK787/ZK222584 With Bevacizumab in Patients With Refractory and/or Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05891171 -
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
|
Phase 1 | |
| Not yet recruiting |
NCT05987605 -
Clinical Study of 1A46 Drug Substance
|
Phase 1 | |
| Terminated |
NCT02608268 -
Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
|
Phase 1/Phase 2 | |
| Terminated |
NCT03277352 -
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05577182 -
Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT04831996 -
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment.
|
Phase 1 | |
| Completed |
NCT02737501 -
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
|
Phase 3 | |
| Completed |
NCT03158272 -
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
|
Phase 1 |