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

NCT06027346 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-09-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shijiazhuang Yiling Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • gang Ji, PI · The First Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027346 on ClinicalTrials.gov