Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation Trial of KGX101 Administered as a Monotherapy to Patients With Advanced or Metastatic Solid Tumors
This is a first-in-human, multicenter, Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of KGX101, a tumor-activated interleukin 12 prodrug, as monotherapy in patients with advanced or metastatic solid tumors.
This study will enrol a maximum of 27 participants depending on the number of dose escalations needed. This study will assess the safety and tolerability of KGX101 monotherapy with a modified accelerated titration and a standard 3+3 dose escalation design to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). The total duration of modified accelerated titration period participation for each participant will be 70 days, including a 28-day screening, a 28-day DLT assessment and a 14-day washout. Dose escalation period, the total duration of participation for each participant will vary depending on events outcome. The participations will receive KGX101 intravenous infusion every 3 weeks at assigned escalating dose until disease progression or discontinuation criterion is met. ;
| 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 | |
| Recruiting |
NCT06448364 -
A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination
|
Phase 1 | |
| Active, not recruiting |
NCT04866134 -
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 |