Trials / Completed
CompletedNCT05309187
Dose-Escalation and Dose-Expansion Study of IO-202 and IO-202+Pembrolizumab in Solid Tumors
A Phase 1, Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study of IO-202 in Combination With Pembrolizumab in Subjects With Advanced, Relapsed, or Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Immune-Onc Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess safety and tolerability of increasing doses of IO-202 either as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors, and select the recommended Phase 2 dose (RP2D).
Detailed description
This is a Phase 1, open-label, multicenter, dose-escalation and dose-expansion study of IO-202 in adult subjects with advanced relapsed or refractory solid tumors to study safety, tolerability, pharmacokinetic, pharmacodynamics and clinical activity of IO-202 as monotherapy or in combination with pembrolizumab and to estimate the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to select the RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IO-202 | IO-202 given as monotherapy |
| BIOLOGICAL | IO-202 + pembrolizumab combination therapy | IO-202 and fixed dose pembrolizumab combination therapy |
| BIOLOGICAL | RP2D of IO-202 + pembrolizumab combination therapy in multiple solid tumor types | Expansion cohorts of the RP2D of IO-202 and fixed dose pembrolizumab combination therapy in multiple tumor types. |
Timeline
- Start date
- 2022-04-11
- Primary completion
- 2024-03-29
- Completion
- 2024-05-31
- First posted
- 2022-04-04
- Last updated
- 2024-06-04
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05309187. Inclusion in this directory is not an endorsement.