A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors

NCT05991583 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IBB0979-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.

Conditions

Advanced Malignant Tumors

Keywords

Advanced Malignant Tumors; B7-H3; IL-10

Outcome Measures

Primary Outcomes (3)

• Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)

  To investigate the safety characteristics.

  3 months after end event visit

• Dose limiting toxicities (DLTs) (Phase Ⅰ)

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

  21 days after first dose

• Objective response rate (ORR) in dose expansion (Phase Ⅱa)

  To explore the clinical effectiveness. Tumor response based on RECIST 1.1.

  Baseline through up to 1 years or until disease progression

Secondary Outcomes (25)

• Pharmacokinetic (PK) Cmax (Phase Ⅰ)

  Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

• Pharmacokinetic (PK) Cmin (Phase Ⅰ)

  Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

• Pharmacokinetic (PK) Tmax (Phase Ⅰ)

  Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

• Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)

  Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

• Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ)

  Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years

Study Arms (3)

Phase Ia - Dose escalation

EXPERIMENTAL

The goal of the Dose Escalation Phase (Part A) is to initially characterize the safety and tolerability of IBB0979, and more specifically to describe the DLTs for each dose level studied and to define the MTD based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period.

Drug: IBB0979

Phase Ib - Dose extension

EXPERIMENTAL

During the Dose Expansion Phase , patients will be enrolled to receive IBB0979 at the MTD established from the Dose Escalation Phase of the study.

Drug: IBB0979

Phase IIa - Clinical Exploratory Stage

EXPERIMENTAL

After finishing Phase 1, invesigators will discuss with the sponsor about how to carry out the Phase IIa due to the results acheived from Phase I.

Drug: IBB0979

Interventions

IBB0979 DRUG

IBB0979 should be subcutaneous injected，qw

Phase IIa - Clinical Exploratory Stage; Phase Ia - Dose escalation; Phase Ib - Dose extension

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 to 80 years old.
• With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate.
• 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 (tumor lesions located in the previous radiation therapy area or other local regional treatment area generally not be considered as measurable lesions, unless the lesion has progression or persists after three months of radiation therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 3 months.
• Adequate organ functions:
• Hematologic system (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.
• Liver function: total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal values (ULN), except for Gilbert's syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN, liver metastases or liver cancer patients with ALT and AST ≤ 5.0 × ULN.
• Renal function: estimated creatinine clearance (Ccr) ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula).
• Thrombin function: international normalized ratio of prothrombin (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
• Eligible patients with fertility (male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners from the time of consent through 90 days after discontinuation of investigational product administration. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum pregnancy test within 7 days prior to the initiation of investigational product administration.
• Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures.

You may not qualify if:

• Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
• History of anti-tumor therapy (chemotherapy within 3 weeks or radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration, with the following exceptions:
• Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of investigational product administration.
• Oral fluoropyrimidines and small molecule targeted drugs should be within 2 weeks prior to the initiation of investigational product administration.
• History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
• History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
• History of systemic corticosteroids (prednisone \>10 mg per day or equivalent) or other immune-suppressive drugs within the 14 days prior to the initiation of investigational product administration. Steroids for topical, ophthalmic, intraarticular, inhaled or nasal administration are allowed.
• Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
• History of prior allogeneic stem-cell or solid organ transplantation.
• Active brain or leptomeningeal metastases with clinical symptoms. Patients with brain metastases are eligible if these have been treated and MRI or CT shows no evidence of progression for at least 8 weeks after treatment completion and within 4 weeks prior to the initiation of investigational product.
• Evidence of active infection requiring intravenous anti-infective therapy.
• Active hepatitis B (HBsAg-positive, and HBV-DNA\> 500 IU/mL or lower limit of study site \[only if the lower limit of study site is above 500 IU/mL\]), active hepatitis C (HCV-RNA\> lower limit of study site).
• Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).
• History of severe cardiovascular and cerebrovascular diseases, including but not limited to:

Sponsors & Collaborators

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

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Li Jin, M.D.

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianxiang cao, M.D.

CONTACT

18018039840; caojianxiang@sunho-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: July 3, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

CN (1)