A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors

Phase 1

Recruiting

• Conditions: MTD
• Interventions: Biological: IBD0333

• Registration Number: NCT06292208
• Lead Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Brief Summary

Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).

Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).

Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.

Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.

Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-03-03
• Study First Posted: 2024-03-05
• Study Start: 2024-03-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBD0333	IBD0333	-

Primary Outcome Measures

Name	Time	Method
MTD	through study completion, an average of 1 year	Maximum tolerated dose
DRDE	through study completion, an average of 1 year	Extended recommended dose
RP2D	through study completion, an average of 1 year	Recommended Phase 2 dose
ORR	through study completion, an average of 1 year	Objective response rate
Dose limiting toxicity (DLT)	28 days after first dose(dose-escalation phase)	To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

Secondary Outcome Measures

Name	Time	Method
DCR	through study completion, an average of 1 year	Disease control rate
PFS	through study completion, an average of 1 year	Progression-free survival
Frequency of adverse events (AEs) and SAEs	through study completion, an average of 1 year	To investigate the safety characteristics.
ADA	through study completion, an average of 1 year	Anti-drug antibody
DoR	through study completion, an average of 1 year	Duration of relief
ORR	through study completion, an average of 1 year	Objective response rate
pharmacokinetic parameters	through study completion, an average of 1 year	t1/2

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China