NCT05235438

Safety and Toxicity Study of IMM27M in Patients With Advanced Solid Tumor

A Phase 1 Study to Evaluate IMM27M Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity in Patients With Advanced, Metastatic Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open label, multi-center and fist in human dose escalation study, to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with advanced and metastatic solid tumor.

Detailed description

Dose escalation (Ia) will recruit 16 disease progress after stand of care(SOC) , no tolerance of SOC solid tumor patients, including malignant melanoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer, ovarian cancer, endometrial cancer, triple negative breast cancer, small cell lung cancer, renal cell carcinoma, squamous cell cancer of head and neck, pancreatic cancer, etc. IMM27M will be dosed every three weeks (Q3W), the study will be conducted by adjusted 3+3 dose escalation study design, the fist dose is 0.1mg/kg based on the non-clinical study data and NOVEL assessment, the dose level will be 0.1, 0.3, 1.0, 2.0, 3.0 mg/kg, the first dose will recruit 1 patient to avoid patients under no efficacy dose, then the conventional 3+3 study design will start since second dose. Patients will be observed 3 weeks after the dose, this is also the DLT observation period, patients will be dosed until intolerability, progressed, death or informed consent withdraw, the total duration of treatment will be 48 weeks.

Conditions

• Oncology
• CTLA4 Haploinsufficiency

Interventions

Type	Name	Description
DRUG	IMM27M	IMM27M injection

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-08-30
• Completion: 2024-08-30
• First posted: 2022-02-11
• Last updated: 2023-05-24

Locations

6 sites across 1 country: China