Solid Tumor Clinical Trial
Official title:
A Phase 1 Multicenter, Dose Escalation, Cohort Extension and Dose and Disease Expansion Study of APL-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
The purpose of this study is to determine the safety, tolerability, and recommended dose schedule of APL-501 in individuals with advanced or relapsed or recurrent solid tumors.
This is a Phase 1, multicenter, 3-part study with a Dose-Escalation Segment, Cohort Extension and Dose and Disease Expansion cohorts of APL-501 injection, a humanized IgG4 monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. Select advanced solid tumor malignancies will receive escalating doses of APL-501. Dose escalation will occur in three subject cohorts until a protocol defined dose limited toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a tentative maximum tolerated dose (MTD) or biologically effective dose (BED) is determined. Cohort Extension will evaluate APL-501 at 3 mg/kg and 10 mg/kg on Day 1 and Day 15 every 28 days. At the tentative MTD, BED or recommended Phase 2 dose (RP2D), at least two tumor types in the Dose and Disease Expansion will be assessed at an equivalent non-weight based dose to further evaluate toxicity and preliminary efficacy. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05580991 -
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Recruiting |
NCT05159388 -
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06014502 -
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04107311 -
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
|
||
Active, not recruiting |
NCT04078152 -
Durvalumab Long-Term Safety and Efficacy Study
|
Phase 4 | |
Completed |
NCT02250157 -
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03943004 -
Trial of DFP-14927 in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
Recruiting |
NCT05798546 -
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
|
Phase 1 | |
Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT00479128 -
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04143789 -
Evaluation of AP-002 in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 |