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

NCT05508100 | Completed Phase 1

• 1 other identifier: IO-108-CL-002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 14

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Maximum plasma concentration (Cmax) of IO-108

  through study completion, an average of 2 years

• Steady state concentration of IO-108

  through study completion, an average of 2 years

• Anti-drug antibodies (ADA) of IO-108

  through study completion, an average of 2 years

• Preliminary anti-tumor activity

  through study completion, an average of 2 years

• Preliminary anti-tumor activity

  through study completion, an average of 2 years

Study Arms (3)

Part A: IO-108 monotherapy dose confirmation

EXPERIMENTAL

Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days.

Biological: IO-108

Part B: IO-108 + anti-PD-1 dose confirmation.

EXPERIMENTAL

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.

Biological: IO-108 + pembrolizumab; Biological: IO-108 + tislelizumab

Part C: Dose expansion

EXPERIMENTAL

Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts.

Biological: IO-108 + pembrolizumab; Biological: IO-108 + tislelizumab

Interventions

IO-108 BIOLOGICAL

IO-108, intravenously, on Day 1 of each 21-day cycle.

Part A: IO-108 monotherapy dose confirmation

IO-108 + pembrolizumab BIOLOGICAL

IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.

Also known as: IO-108 + Keytruda®

Part B: IO-108 + anti-PD-1 dose confirmation.; Part C: Dose expansion

IO-108 + tislelizumab BIOLOGICAL

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 B: IO-108 + anti-PD-1 dose confirmation.; Part C: Dose expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, and \< 75.
• 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.
• Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Patients must have adequate hematologic function, hepatic function and renal function.

You may not qualify if:

• Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
• 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.
• 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.
• History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.

Sponsors & Collaborators

• Immune-Onc Therapeutics: lead

Study Sites (14)

The First Affiliated Hospital of Fujian Medical University

Fujian, Fuzhou, China

Location

1st affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Location

4th Hospitla of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Harbin Cancer Hospital

Harbin, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330052, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Lin Yi Cancer Hospital

Linyi, Shandong, China

Location

Shanghai Dong Fang Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

1st Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Location

Sir RUN RUN SHAW HOSPITAL

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

pembrolizumab; tislelizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 19, 2022
• Study Start: September 9, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 24, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)