Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
NCT ID: NCT05508100
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2022-09-09
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma
NCT03821363
A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours
NCT06027346
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
NCT05101070
IN10018 Combination Therapy in Previously-treated Solid Tumors
NCT05982522
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors
NCT05572684
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: IO-108 monotherapy dose confirmation
Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days.
IO-108
IO-108, intravenously, on Day 1 of each 21-day cycle.
Part B: IO-108 + anti-PD-1 dose confirmation.
Patients will receive IO-108 in combination with with a fixed dose of pembrolizumab, intravenously, every 21 days; Patients will receive IO-108 in combination with with a fixed dose of tislelizumab, intravenously, every 21 days.
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.
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.
Part C: Dose expansion
Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IO-108
IO-108, intravenously, on Day 1 of each 21-day cycle.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists.
Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria.
3. Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
5. Patients must have adequate hematologic function, hepatic function and renal function.
Exclusion Criteria
2. Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy \< 4 weeks prior to their first day of study drug administration.
3. Requires systemic corticosteroids at a dose of \>10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose.
4. History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Immune-Onc Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Fujian Medical University
Fujian, Fuzhou, China
1st affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
4th Hospitla of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Lin Yi Cancer Hospital
Linyi, Shandong, China
Shanghai Dong Fang Hospital
Shanghai, Shanghai Municipality, China
1st Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
Sir RUN RUN SHAW HOSPITAL
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IO-108-CL-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.