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

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.

Timeline

Start

2023-07-17

Primary completion

2026-05

Completion

2026-05

Drugs

Indications