Trials / Completed
CompletedNCT02904226
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors
Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Jounce Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Detailed description
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JTX-2011 | Specified dose on specified days |
| DRUG | Nivolumab | Specified dose on specified days |
| DRUG | Ipilimumab | Specified dose on specified days |
| DRUG | Pembrolizumab | Specified dose on specified days |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2016-09-16
- Last updated
- 2023-07-03
- Results posted
- 2021-09-09
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02904226. Inclusion in this directory is not an endorsement.