Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
In Phase 2, study subjects will be enrolled into 6 distinct expansion (EXP) cohorts: - EXP-1: ROS1 TKI-naïve ROS1+ NSCLC. Up to one prior line of chemotherapy OR immunotherapy is allowed - EXP-2: 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1+ NSCLC. Disease progression, or intolerant to one prior line of a ROS1 TKI. Must have received one prior line of platinum based chemotherapy OR one prior line of platinum based chemotherapy in combination with immunotherapy before or after a ROS1 TKI - EXP-3: 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1+ NSCLC. Disease progression, or intolerant to 2 prior lines of a ROS1 TKI treatment. No prior lines of chemotherapy or immunotherapy are allowed. - EXP-4: 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy. Disease progression or intolerant to one prior line of a ROS1 TKI. No prior lines of chemotherapy or immunotherapy are allowed. - EXP-5: TRK TKI-naïve NTRK+ solid tumors. Any number of prior lines of chemo or immunotherapy is allowed. - EXP-6: TRK TKI-pretreated NTRK+ solid tumors. Disease progression, or intolerant to 1 or 2 prior TRK TKIs. Any number of prior lines of chemo- or immunotherapy are allowed. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03993873 -
Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05494918 -
First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors
|
Phase 1 | |
| Completed |
NCT02281409 -
Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01928459 -
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
|
Phase 1 | |
| Completed |
NCT01449370 -
Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer
|
Phase 1 | |
| Recruiting |
NCT06031441 -
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT03059823 -
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT03573544 -
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03893955 -
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00878423 -
Study to Assess the Safety of Escalating Doses of AT13387 in Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT00149019 -
Immunotherapy of Cancer Using Donor Lymphocytes Labelled With In-vitro Bispecific Antibodies.
|
Phase 2 | |
| Terminated |
NCT03854227 -
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04094610 -
A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01543763 -
Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02228811 -
A Study of DCC-2701 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05853367 -
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
|
Phase 1 | |
| Completed |
NCT02097810 -
Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
|
Phase 1 | |
| Recruiting |
NCT05836324 -
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT03910530 -
A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT00148993 -
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
|
Phase 1/Phase 2 |