A Study Of IMM47 In Subjects With Advanced Solid Tumors

NCT05985083 | Unknown Phase 1 DMC

• 1 other identifier: IMM47-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This is a first-in-human (FIH), open-label, multi-center, phase I study to evaluate the safety, tolerance, pharmacokinetics (PK), immunogenicity, preliminary anti-tumor activity, pharmacodynamics, and biomarker activity of IMM47 monotherapy in subjects with advanced solid tumors.

Conditions

Oncology

Keywords

ADVANCED SOLID TUMORS

Outcome Measures

Primary Outcomes (5)

• DLTs

  Dose Limiting Toxicities

  Baseline up to 28 days after the first dose

• MTD(maximum tolerated dose)

  To determine the maximum tolerated dose (MTD) of IMM47 in subjects with advanced solid tumors

  From start of treatment to treatment termination visit, up to 48 weeks

• adverse events (AEs)

  Incidence and characteristics of adverse events (AEs)

  Baseline up to 30 days after the last dose of study drug, up to 48 weeks

• RP2D (recommended Phase 2 dose)

  To determine the recommended Phase 2 dose (RP2D) of IMM47 in in subjects with advanced solid tumors

  From start of treatment to treatment termination visit, up to 48 weeks

• serious adverse events (SAEs)

  Incidence and characteristics of serious adverse events (SAEs)

  Baseline up to 30 days after the last dose of study drug, up to 48 weeks

Secondary Outcomes (10)

• Maximum Plasma Concentration (Cmax)

  48 weeks of treatment cycles

• Time to maximum concentration (Tmax)

  48 weeks of treatment cycles

• Elimination half-life (t1/2)

  48 weeks of treatment cycles

• Immunogenicity

  48 weeks of treatment cycles

• Overall Rate Response (ORR)

  When the last subject enrolled completes approximately 48 weeks of treatment

Study Arms (1)

Dose escalation

EXPERIMENTAL

It's a dose escalation to identify the Maximum Tolerated dose (MTD) , recommended Phase II dose (RP2D) of IMM47, an accelerated titration method and the traditional "3+3" design method will be adopted. IMM47 will be sequentially escalated at the dose of 5 μg/kg，50 μg/kg, 250 μg/kg，1.0 mg/kg，3.0 mg/kg and 5.0 mg/kg or higher dose levels, administered via intravenous infusion every 2 weeks in 28-day treatment cycles. The duration of the infusion is 120 min (± 10 min) for the 1st infusion and 60 min (± 5 min) for subsequent infusions.

Drug: IMM47

Interventions

IMM47 DRUG

IMM47 is humanized mAb targeting CD24 to be administered via intravenous infusion every 2 weeks in 28-day treatment cycles.

Dose escalation

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at the time of signing the ICF.
• With an expected life expectancy of ≥ 12 weeks.
• With an ECOG performance status score of 0-1.
• For phase Ia, subjects diagnosed histologically or cytologically with advanced solidtumors (preferred but not limited to ovarian, esophageal, breast, lung, colorectal, hepatocellular, pancreatic, urothelial, prostate, and head and neck cancers) that have failed previous standard treatments or no standard treatment is available.
• The intervals for discontinuing the last anti-tumor therapy prior to the first dose of the investigational product are required as follows Subjects who previously received chemotherapeutic agents must have discontinued the drug for more than 3 weeks.
• Subjects who previously received small-molecule targeted therapy must have discontinued treatment for more than 2 weeks or 5 half-lives of the drug (whichever is longer).
• Subjects who previously received monoclonal antibodies (eg. CD20 antibody, PD-1/PD-L1 antibody) must have discontinued the treatment for more than 4 weeks.
• Subjects who previously underwent palliative radiation therapy must have discontinued the treatment for more than 2 weeks.
• With suitable organ and hematopoietic functions:
• Neutrophil count ≥1.5 × 109/L. (no growth factor therapy within 4 weeks prior to Screening).
• Platelet count ≥100 × 109/L ; for subjects with HCC, platelet count ≥75 ×109 /L Hemoglobin ≥ 90 g/L (subjects may be transfused \>2 weeks before screening, but should not be transfusion-dependent).
• Total Bilirubin (TBIL) ≤ 1.5 × ULN (or ≤ 3.0 × ULN if subject has a documented history of Gilbert's syndrome or liver metastases).
• Both aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (or both AST and ALT ≤ 5.0 × ULN if subject has a documented history of liver metastases).
• International normalized ratio (INR) ≤1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5× ULN.
• Left ventricular ejection fraction (LVEF) ≥ 50%. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft and Gault Equation) if serum creatinine \>1.5 ULN. Lower calculated creatinine clearance values may be allowed at the Investigator's discretion and in consultation with the Medical Monitor and Sponsor

You may not qualify if:

• Subjects who previously received CD24 targeted therapy.
• Prior allogeneic hematopoietic stem cell transplant or other organ transplants.
• Subjects with known active central nervous system (CNS) metastases or primary CNS Lymphoma. Stable previously treated CNS metastases in subjects who are asymptomatic and have not been on corticosteroid therapy within 3 weeks prior to screening are not considered to be active.
• Subjects in need of immediate cytoreduction therapy.
• Significant medical disease or conditions, as assessed by the Investigators and Sponsor that would substantially increase the risk-benefit ratio of participating in the study. This includes but is not limited to:
• Uncontrolled hypertension (systolic BP \> 160 mmHg or diastolic BP \> 90 mmHg), pulmonary hypertension, or unstable angina.
• New York Heart Association (NYHA) Grade II or higher congestive heart failure. History of myocardial infarction, or bypass surgery or stent placement within 6 months prior to the first dose of the investigational product.
• Severe arrhythmia requiring treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia that, according to the judgment of the investigators, do not affect the study).
• QTc interval \> 450 ms for males and \> 470 ms for females (Fridericia's Formula).
• History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to the first dose of investigational product.
• Concurrent interstitial lung disease (ILD) (except for radiation therapy-induced loco regional interstitial pneumonia), severe chronic obstructive pulmonary disease, severe pulmonary insufficiency.
• Diseases that may cause gastrointestinal bleeding or perforation. Known inherited or acquired bleeding disorders Uncontrolled diabetes mellitus. Thoracoabdominal or pericardial effusions that cannot be controlled by puncture and drainage and require repeated drainage or with significant symptoms.
• History of liver disease, including cirrhosis, alcoholic liver disease, etc.
• Concurrent medical condition requiring systemic corticosteroids (prednisone daily dose \> 10 mg or equivalent dose) within 7 days prior to first dose of the investigational product or during the study, or other immunosuppressive medications, but not including locoregional corticoids by intranasal, inhalated or other routes of administration, or physiological-dose corticoids systemic-therapy.
• Known active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead
• IQVIA RDS Inc.: collaborator

Study Sites (4)

Scientia Clinical Research Ltd, NSW

Sydney, New South Wales, 2031, Australia

RECRUITING

Macquarie University Clinical Trials Unit (MQ CTU)

Sydney, New South Wales, 2109, Australia

NOT YET RECRUITING

Icon Cancer Centre South Brisbane, QLD

Brisbane, Queensland, 4101, Australia

RECRUITING

John Flynn Private Hospital

Gold Coast, Queensland, 4224, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jim Coward, A/Prof

  Icon Cancer Centre South Brisbane, QLD

  PRINCIPAL INVESTIGATOR

• Charlotte Lemech, Dr

  Scientia Clinical Research Ltd, NSW

  PRINCIPAL INVESTIGATOR

• Megan Crumbaker, Dr

  Macquarie University Clinical Trials Unit (MQ CTU)

  PRINCIPAL INVESTIGATOR

• David Martin, Dr

  John Flynn Private Hospital, QLD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiying Lu, Dr.

CONTACT

+86 21 38016387; qiying.lu@immuneonco.com

Bin Pan, Dr

CONTACT

+86 21 38016387; bin.pan@immuneonco.com

Study Design

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

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 14, 2023
• Study Start: August 18, 2023
• Primary Completion: December 26, 2024
• Study Completion: January 23, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: starting in Jun 1st 2025.

Locations

AU (4)