Clinical trial NCT05508100: Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Immune-Onc Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18, and \< 75.
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:

1. Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
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.
5. Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108
timeFrame: through study completion, an average of 2 years
measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 in combination with pembrolizumab or tislelizumab
timeFrame: through study completion, an average of 2 years
measure: Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of IO-108
timeFrame: through study completion, an average of 2 years
measure: Steady state concentration of IO-108
timeFrame: through study completion, an average of 2 years
measure: Anti-drug antibodies (ADA) of IO-108
timeFrame: through study completion, an average of 2 years
measure: Preliminary anti-tumor activity
timeFrame: through study completion, an average of 2 years
measure: Preliminary anti-tumor activity
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Fujian
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fuzhou
city: Haikou
country: China
facility: 1st affiliated Hospital of Hainan Medical University
state: Hainan
city: Shijia Zhuang
country: China
facility: 4th Hospitla of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: Lin Yi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Dong Fang Hospital
state: Shanghai
city: Xian
country: China
facility: 1st Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Hangzhou
country: China
facility: Sir RUN RUN SHAW HOSPITAL
state: Zhejiang
Study officials:
References: