Locally Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
Dose Escalation and Extension Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Anti-5T4 CAR-raNK Cell Therapy in Locally Advanced or Metastatic Solid Tumors
This study is a multicenter, open-label, investigator-initiated trial (IIT), divided into dose escalation (Part A) and dose extension (Part B) phases to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacokinetics (PD) and initial efficacy of conjugated antibody redirecting ready-to-use allogeneic NK (CAR-raNK) cells that target trophoblast glycoprotein (5T4) in patients with locally advanced or metastatic solid tumors.
Part A is a dose escalation study to evaluate maximum toxic dose (MTD) and/or recommended phase II dose (RP2D) which adopts the 3+3 dose escalation design protocol. The dose is respectively 3.0×10^9 live cells, 6.0×10^9 live cells and 9.0×10^9 live cells (if the safety of dose group with 9.0×10^9 live cells is still good, the Safety Monitoring Committee (SMC) will co-decide whether to continue the dose escalation and the specific dose based on the obtained data on safety, efficacy, and PK). The 3.0×10^9 live cell dose group is given on days 1 and 3 of each cycle (21 days), and the follow-up dose group is given on days 1 and 8 of each cycle (21 days).3-6 subjects will be enrolled at every dose level. The first and second subjects in the same group shall be enrolled at an interval of at least 7 days, for the purpose of ensuring their safety. Only when the dose-limiting toxicity (DLT) of all subjects in the previous dose group was observed can the enrollment of the next dose group get started. Part B is the dose extension study. After recommended phase II dose (RP2D) is determined in Part A, the SMC will discuss whether to conduct the Part B study. This stage will be carried out in different tumor types with high expression of 5T4 antigen, and 6 to 10 subjects will be enrolled in each tumor type, and all subjects will receive anti-5T4 CAR-raNK cell therapy at RP2D level. Every 21 days is one cycle, and the administration is performed on day 1 and day 8 of each cycle. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04564417 -
First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04511845 -
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
|
Phase 1 | |
| Active, not recruiting |
NCT04128423 -
Study of AMV564 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05012618 -
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
|
Phase 1 | |
| Recruiting |
NCT05581004 -
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT03736850 -
Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01021748 -
A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)
|
Phase 1 | |
| Completed |
NCT01713036 -
Oral Bioavailability and Mass Balance Trial With Pimasertib
|
Phase 1 | |
| Recruiting |
NCT05116709 -
Assessment of Safety and Preliminary Clinical Efficacy With BAT6005 in Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05102214 -
HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03478995 -
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06293651 -
Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06328439 -
A Study to Evaluate ANS014004 in Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT05830539 -
IN10018 Combination Therapy in Previously-treated Locally Advanced or Metastatic Solid Tumor Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05205109 -
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT05360381 -
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT03150810 -
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05957471 -
Study of BC3195 Monotherapy in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT03565991 -
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT06244992 -
PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 |