NCT06027346

A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours

A Phase I Study of BIO-008 Injection for Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 1: Dose escalation study (Phase Ia) Main purpose: Evaluate the safety and tolerability of BIO-008 in patients with advanced solid tumors, and determine the maximum tolerable dose (MTD) and dose limiting toxicity (DLT) of BIO-008. Secondary purpose: Evaluate the pharmacokinetic (PK) characteristics of BIO-008; Evaluate the immunogenicity of BIO-008. Exploratory purposes: Preliminary evaluation of the anti-tumor activity of BIO-008 (if available); Detect the expression of CLDN18.2 in tumor tissue and explore its correlation with BIO-008 anti-tumor activity indicators (only applicable to subjects who can provide fresh or archived tumor tissue samples before the first administration). Phase 2: Dose Extension Study (Phase Ib) Main purpose: • Preliminary evaluation of ORR of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer (GC/GEJ), pancreatic cancer (PC) and other solid tumors; Determine the recommended dose for clinical phase II (RP2D). Secondary purpose: Evaluate the safety and tolerability of BIO-008; Evaluate the PK characteristics of BIO-008; Evaluate the immunogenicity of BIO-008; • Evaluate other anti-tumor activity indicators of BIO-008 in patients with CLDN18.2 positive advanced gastric cancer or gastroesophageal junction cancer, pancreatic cancer and other solid tumors; Evaluate the correlation between the anti-tumor activity of BIO-008 and the expression of CLDN18.2.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Bio-008	The subjects in each dose group received the corresponding dose of BIO-008 monotherapy, administered intravenously (ivd) for a duration of 0.5 to 3 hours (the researchers can adjust the administration time according to the patient's tolerance). If there is an infusion reaction, the infusion can be suspended and completed within 12 hours. Administer on the first day of each cycle, once every 3 weeks (1 cycle, i.e. 21 days) (Q3W) until the criteria for termination of treatment or withdrawal from the study are met, whichever occurs first.

Timeline

• Start date: 2023-07-17
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-09-07
• Last updated: 2023-09-07

Locations

1 site across 1 country: China