Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11, an anti-CD93 monoclonal antibody, as a monotherapy and in combination in patients with advanced or metastatic solid tumors.
The drug being tested in this study is called DCSZ11. DCSZ11 is being tested to treat people who have advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase. The study will enroll approximately 138 patients in dose escalation, and approximately 113 participants in the dose expansion phase. Participants will receive escalating doses of DCSZ11 and a fixed dose of pembrolizumab until DCSZ11 doses for phase 1b are selected: - Phase 1a DCSZ11 monotherapy Dose Escalation. - Phase 1a DCSZ11 in combination with fixed dose of pembrolizumab Dose Escalation. Once Phase 1b doses are selected for Phase 1b, participants of select advanced or metastatic solid tumors will receive DCSZ11 in below defined cohorts in Phase 1b: - Phase 1b cohort 1 NSCLC. - Phase 1b cohort 2 Microsatellite Stable Colorectal Cancer (MSS-CRC) without liver involvement. - Phase 1b cohort 3 MSS-CRC with liver involvement. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 60 months. Participants will make multiple visits to the clinic, and survival follow-up for a maximum of up to 12 months after the last dose of the study drug. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05017012 -
A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of MK-3475A (Pembrolizumab Formulated With MK-5180) In Advanced Solid Tumors (MK-3475A-C18)
|
Phase 1 | |
Completed |
NCT02261532 -
A Phase I Study of TAS-102 in Solid Tumors
|
Phase 1 | |
Completed |
NCT00748553 -
A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03248843 -
A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05572684 -
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT04003623 -
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
|
Phase 2 | |
Terminated |
NCT05496595 -
DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT01928394 -
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01506934 -
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03730337 -
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04586270 -
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
|
Phase 1 | |
Recruiting |
NCT06248411 -
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06389526 -
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03665285 -
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05957081 -
Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309
|
Phase 1 | |
Active, not recruiting |
NCT03316638 -
A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01355302 -
E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01014429 -
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06074497 -
A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06448364 -
A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination
|
Phase 1 |