Trials / Completed
CompletedNCT05508100
Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
A Phase 1, Open-Label, Multicenter Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IO-108 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody in Adult Patients With Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Immune-Onc Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IO-108 | IO-108, intravenously, on Day 1 of each 21-day cycle. |
| BIOLOGICAL | IO-108 + pembrolizumab | IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle. |
| BIOLOGICAL | IO-108 + tislelizumab | IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle. |
Timeline
- Start date
- 2022-09-09
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2022-08-19
- Last updated
- 2024-05-24
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05508100. Inclusion in this directory is not an endorsement.