Metastatic Solid Tumor Clinical Trial
Official title:
A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.
This is a multi-center, first in human, open-label, 2-part, dose escalation and expansion study to define safety, tolerability, maximum tolerated dose, pharmacologically active dose, assess preliminary efficacy, and explore predictive and pharmacodynamic biomarkers in up to 126 participants with advanced solid tumors. Expansion cohorts of participants, treated at the RP2D, with small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data. Starting dose will be 10 mg orally once daily, 4 days on and 3 days off cycle. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Terminated |
NCT05071183 -
A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05530200 -
PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.
|
Phase 2 | |
| Active, not recruiting |
NCT04447651 -
Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
|
||
| Recruiting |
NCT04419532 -
A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04137900 -
Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT04585750 -
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05028478 -
A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05867121 -
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05471271 -
IL-2 PET Imaging in Advanced Solid Tumours
|
N/A | |
| Active, not recruiting |
NCT03964727 -
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT06108050 -
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05688280 -
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
|
Phase 1/Phase 2 | |
| Completed |
NCT04914117 -
A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours
|
Phase 1 | |
| Completed |
NCT00997529 -
Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors
|
N/A | |
| Recruiting |
NCT04614740 -
The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06163391 -
A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT06415487 -
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
|
Phase 1 |