Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors

NCT06001684 | Unknown Phase 1

• 1 other identifier: IBR854-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLTs)

  To collect dose limiting toxicities (DLTs) occurring within 21 days after the first dose

  From day1 to day 21

• The incidence and severity of adverse events (AEs)

  To evaluate the safety of IBR854 cell injection

  From day 1 to day 90 after the first dose

Secondary Outcomes (7)

• Objective response rate (ORR)

  1 year

• Disease control rate (DCR)

  1 year

• Duration of remission (DOR)

  1 year

• Progression-free survival (PFS)

  1 year

• Overall survival (OS)

  1 year

Study Arms (1)

IBR854 Cell Injection

EXPERIMENTAL

The minimum initial dose is 3.0×10\^9 cells and then escalate to 5.0×10\^9 cells and 7.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

Biological: IBR854 Cell Injection

Interventions

IBR854 Cell Injection BIOLOGICAL

The minimum initial dose is 3.0×10\^9 cells and then escalate to 5.0×10\^9 cells and 7.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

IBR854 Cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
• Age: adult at the age of 18-75 (both inclusive), female or male.
• Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic solid tumors (which can be diagnosed with the use of tumor markers in combination with imaging for specific advanced tumors, such as liver cancer) who have no current standard of care.
• Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time \>3 months.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria, the subjects have at least one target lesion (non-lymph node lesion with major diameter ≥ 1.0cm or lymph node lesion with minor diameter ≥ 1.5 cm). A lesion that is within the field of previous radiotherapy could not be considered a target unless there is radiographic evidence of progression.
• Organ function during screening should meet the following criteria:
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet (PLT) ≥75×10\^9/L; Hemoglobin (Hb)≥80g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
• Alanine aminotransferase (ALT)≤3×ULN (Patients with liver metastasis: ≤5×ULN); Aspartate aminotransferase (AST)≤3×ULN (Patients with liver metastasis: ≤5×ULN);
• Creatinine (Cr) ≤2× ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 2× ULN) \> 50ml/min (Cockcroft-Gault formula);
• Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN (Patients with anticoagulants: ≤ 2.5×ULN).
• Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.

You may not qualify if:

• Have received systemic antitumor therapy within 4 weeks or five half-lives of the drug (whichever is longer) before the first dose of the study drug: Systemic chemotherapy (2 weeks for oral fluorouracil, 6 weeks for mitomycin C and nitrosoureas), endocrine therapy, targeted therapy (2 weeks or 5 half-life for small molecule targeted therapy, whichever is longer), immunotherapy, radical radiotherapy, tumor embolization, Chinese herbal medicine for anti-tumor indications, etc. Or received palliative radiotherapy within 2 weeks before the first dose.
• Toxic effects from previous antitumor therapy have not returned to grade 1 or less (other than alopecia or fatigue).
• Any prior adoptive cellular immunotherapy.
• Active brain metastases (one of the following criteria: clinical symptoms; A new diagnosis; Progression after previous local treatment).
• Have undergone major organ surgery within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
• Long-term (≥ 3 days) treatment with a glucocorticoid (prednisone \> 10 mg per day or equivalent) or another immunosuppressive agent is anticipated to be required during the study. Inhaled or topical steroid hormones are allowed in subjects without active autoimmune disease
• Have received a live or attenuated vaccine within 4 weeks before the first dose or plan to receive a live or attenuated vaccine during the study period.
• Have severe infections that cannot be controlled.
• Active hepatitis B, hepatitis C virus infection or HIV infection.
• Have undergone an allogeneic bone marrow transplant or other organ transplant.
• Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission).
• Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
• There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
• Prolonged QT interval corrected with Fridericia's method (QTcF) (\>450 ms in men; \>470 ms for women)
• Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;

Sponsors & Collaborators

• Imbioray (Hangzhou) Biomedicine Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Study Officials

• Ning Li, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD, PhD

CONTACT

+86-010-87788787; cancergcp@163.com

Shuhang Wang, MD, PhD

CONTACT

+86-010-87788787; cancergcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)