A Study of the ILB-3101 in Patients with Advanced Solid Tumors

NCT06426680 | Recruiting Phase 1

• 1 other identifier: CILB3101A101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• DLT

  Dose-limiting toxicity for ILB-3101

  Up to day 21 from the first dose

• MTD

  Maximum tolerated dose (MTD) for ILB-3101

  Up to day 21 from the first dose

Secondary Outcomes (10)

• ORR

  From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

• Incidence and severity of adverse events (AEs)

  From the first dose through 90 days post end of treatment

• Percentage of participants with antibodies to ILB-3101 in serum

  From pre-dose to 90 days post end of treatmen

• Observed maximum plasma concentration (Cmax) of ILB-3101 in participants with advanced solid tumor

  From pre-dose to 21 days after the first dose on Cycle 1

• Time to reach maximum plasma concentration (Tmax) of ILB-3101 following the first dose in participants with advanced solid tumor

  From pre-dose to 21 days after the first dose on Cycle 1

Study Arms (1)

ILB-3101

EXPERIMENTAL

There are eight escalating dose cohorts. Intravenous (IV) administration of ILB-3101 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Biological: ILB-3101

Interventions

ILB-3101 BIOLOGICAL

There are eight escalating dose cohorts.

ILB-3101

Eligibility Criteria

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

You may qualify if:

• Have signed informed consent forms voluntarily.
• years old.
• Having an ECOG performance status score of 0 or 1.
• With an expected survival of more than 12 weeks.
• Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable.
• Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor.
• At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesion is present during the dose escalation phase (CRPC can be determined based on PCWG3).
• Having sufficient bone marrow, liver, and kidney functions (based on the normal value of the clinical trial site):
• Absolute neutrophil count (ANC) ≥ 1.5×109/L.
• Platelets ≥ 75×109/L.
• Hemoglobin ≥ 90g/L.
• Total serum bilirubin ≤ 1.5×upper limit of normal (ULN).
• Without liver metastases, ALT, AST ≤ 2.5×ULN; with liver metastases, ALT, AST ≤ 5×ULN.
• Serum creatinine ≤1.5 × ULN.
• Creatinine clearance rate (CrCl) (creatinine only ˃ Calculation required for 1.5 × ULN ≥50 mL/min (Calculate according to Cockcroft Fault formula),

You may not qualify if:

• Within 3 weeks prior to the first administration, systemic anti-tumor therapy has been received, including chemotherapy, curative radiotherapy (palliative radiotherapy for a single lesion within 3 weeks prior to enrollment is allowed, and radiotherapy is not allowed for measurable lesions before enrollment unless it is confirmed that the lesion has progressed after radiotherapy), biological therapy, immunotherapy, etc., except for the following:
• Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug.
• Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer).
• Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug.
• Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug.
• Patients who received other clinical trial drug within 4 weeks before the first dosing.
• Within 3 years prior to the first trial drug treatment, the patient had other active malignant tumors, except for the tumors participating in this study and other locally cured tumors (such as basal skin cancer, papillary thyroid cancer, or any type of in situ cancer that has been completely removed, such as cervical in situ cancer, ductal carcinoma in situ, etc.).
• Suffering from central nervous system metastasis and/or cancerous meningitis. Except for asymptomatic or asymptomatic central nervous system metastases that have been clinically controlled but are judged stable by investigators, the following conditions must also be met:
• Stable clinical symptoms for at least 4 weeks before receiving trial drug treatment.
• No evidence of central nervous system disease progression was found in imaging examinations within 4 weeks prior to the first trial drug treatment.
• Antiepileptic drugs have been discontinued at least 2 weeks prior to the first trial drug treatment, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of steroids.
• For patients with intracranial lesions, if they have received treatment (such as radiotherapy) before the first trial drug treatment, elution should be ≥ 2 weeks. Cancer induced encephalitis should be excluded regardless of its stable clinical condition.
• Receiving drug therapy known to prolong the QT interval or potentially lead to torsade de pointe ventricular tachycardia; Or continue to receive these medications during the research period.
• Acute coronary syndrome occurring within the past 6 months, including myocardial infarction, unstable angina, symptomatic congestive heart failure (New York Heart Association classification II-IV), aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events; Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.
• Suffering from clinically uncontrollable diseases, including but not limited to severe diabetes (diabetes ketoacidosis or hyperglycemia hyperosmolality occurred within 6 months before the first administration, and the detection value of glycosylated hemoglobin in the screening period was ≥ 7.5%); Refractory hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment within the first month of screening) or a history of hypertensive crisis or hypertensive encephalopathy.

Sponsors & Collaborators

• Innolake Biopharm: lead

Study Sites (1)

Fundan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Study Officials

• Jian Zhang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Hongxia Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Li, MD

CONTACT

18610580233; yan.li@innolakebio.com

Xue Wang

CONTACT

xue.wang@innolakebio.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: May 19, 2024
• First Posted: May 23, 2024
• Study Start: October 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)