Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508100
• Other study ID #: IO-108-CL-002
• Status: Recruiting
• Phase: Phase 1
• Start date: September 9, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: Immune-Onc Therapeutics
• Contact: Rita Chen
• Phone: 00862180168666
• Email: rita.chen[@]immnueonc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	The First Affiliated Hospital of Fujian Medical University	Fujian	Fuzhou
China	1st affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	Sir RUN RUN SHAW HOSPITAL	Hangzhou	Zhejiang
China	Harbin Cancer Hospital	Harbin	Heilongjiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Lin Yi Cancer Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shanghai Dong Fang Hospital	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	4th Hospitla of Hebei Medical University	Shijia Zhuang	Hebei
China	Tongji Hospital	Wuhan	Hubei
China	1st Affiliated Hospital of Xi'an Jiaotong University	Xian	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Immune-Onc Therapeutics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108	AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0	through study completion, an average of 2 years
Primary	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	AE severity graded by NCI CTCAE, Version 5.0	through study completion, an average of 2 years
Primary	Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab	ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1	through study completion, an average of 2 years
Secondary	Maximum plasma concentration (Cmax) of IO-108	Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points	through study completion, an average of 2 years
Secondary	Steady state concentration of IO-108	Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points	through study completion, an average of 2 years
Secondary	Anti-drug antibodies (ADA) of IO-108	Determine the incidence and titer of ADAs against IO-108	through study completion, an average of 2 years
Secondary	Preliminary anti-tumor activity	Disease Control Rate, defined as the percentage of patients with CR, PR, or stable disease.	through study completion, an average of 2 years
Secondary	Preliminary anti-tumor activity	Progression-free Survival, defined as the time interval from the first dose date to the occurrence of disease progression or death of any cause	through study completion, an average of 2 years