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

NCT06292208 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IBD0333-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

MTD

Outcome Measures

Primary Outcomes (5)

• MTD

  Maximum tolerated dose

  through study completion, an average of 1 year

• DRDE

  Extended recommended dose

  through study completion, an average of 1 year

• Dose limiting toxicity (DLT)

  To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).

  28 days after first dose(dose-escalation phase)

• RP2D

  Recommended Phase 2 dose

  through study completion, an average of 1 year

• ORR

  Objective response rate

  through study completion, an average of 1 year

Secondary Outcomes (10)

• pharmacokinetic parameters

  through study completion, an average of 1 year

• pharmacokinetic parameters

  through study completion, an average of 1 year

• pharmacokinetic parameters

  through study completion, an average of 1 year

• pharmacokinetic parameters

  through study completion, an average of 1 year

• ADA

  through study completion, an average of 1 year

Study Arms (1)

IBD0333

EXPERIMENTAL

Biological: IBD0333

Interventions

IBD0333 BIOLOGICAL

This is a phase I/II, open, non-randomized, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma in dose-escalation, dose-expansion, and clinical exploration phases.

IBD0333

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible for participation in this trial, the patient must:
• Male or female, 18 to 80 years old.
• Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant.
• There is at least one assessable tumor lesion in the dose escalation phase and at least one measurable lesion in the dose expansion phase according to RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy).
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
• Have a life expectancy of at least 3 months.
• Have adequate organ function as indicated by the following laboratory values.
• Hematological (no transfusion or hematopoietic stimulating factor therapy within 14 days): absolute neutrophil count (ANC)≥1.5×109/L, platelet count (PLT)≥ 90 ×109/L, hemoglobin (HGB)≥90 g/L;
• Hepatic: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN), except for Gilbert syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3.0×ULN, or ALT and AST ≤ 5.0×ULN in patients with liver metastases or liver cancer;
• Renal: creatinine clearance (Ccr)≥50mL/min (calculated according to the Cockcroft-Gault Method:);
• Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
• Eligible patients (male and female) of childbearing potential must agree to use a reliable contraception measure (hormonal or barrier contraception or abstinence) with their partner for the duration of the trial and for at least 120 days after the discontinuation of investigational product. Female patients of childbearing potential must have a negative serum pregnancy test at within 7 days of first dose of investigational product.
• According to the investigator's assessment, the patient could benefit from IBD0333.
• Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.

You may not qualify if:

• Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333.
• History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist.
• History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except:
• Nitrosourea or mitomycin C within 6 weeks prior to the initiation of investigational product;
• Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the initiation of investigational product;
• Chinese patent drugs within 2 weeks prior to the initiation of investigational product.
• History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product.
• History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial.
• History of systemic corticosteroids (prednisone \>10 mg/day or equivalent) or immunosuppressive medication \<14 days prior to the initiation of investigational product. Steroids for topical, ocular, intra-articular, intranasal and inhaled and short-term prophylactic treatment (e.g., to prevent contrast allergy) were allowed.
• Treatment with immunomodulatory agents within 14 days prior to the initiation of investigational product, including but not limited to thymidine, interleukin-2, interferon, etc.
• Vaccination with live attenuated vaccine within 4 weeks prior to the initiation of investigational product.
• History of allogeneic hematopoietic stem cell or organ transplantation.
• Parenchymal brain metastases or meningeal metastases unless previously received therapies and have no evidence of progression on magnetic resonance imaging (MRI) or computed tomography (CT) for at least 8 weeks after the treatment and for 4 weeks prior to the initiation of investigational product.
• Evidence of active infection requiring intravenous systemic therapy.
• History of immunodeficiency, including the positive for human immunodeficiency virus (HIV) antibodies.

Sponsors & Collaborators

• SUNHO（China）BioPharmaceutical CO., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Central Study Contacts

Na Li

CONTACT

18229969355; lina@sunho-bio.com

Jinming Yu, M.D.

CONTACT

13806406293; sdyujinming@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 5, 2024
• Study Start: March 9, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

CN (1)