A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer

Launched by IMMUNEONCO BIOPHARMACEUTICALS (SHANGHAI) INC. · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMM2510, which is being tested alongside standard chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) or triple-negative breast cancer (TNBC). The goal is to see if this combination is safe, how the body processes the medication, and if it helps shrink tumors when used as the first treatment for these cancers.

To be eligible for the trial, participants must be at least 18 years old and have either stage IV NSCLC that hasn’t been treated before or unresectable locally advanced or metastatic TNBC that has not received prior systemic treatment. This means they cannot have had other major cancer treatments before joining the study. Participants will receive the study medication and chemotherapy and will be monitored closely for side effects and effectiveness. It’s important to know that this study is not yet recruiting participants, but it aims to provide valuable information that could help improve cancer treatment in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understand and voluntarily sign the ICF for this study ;
• • 2. Aged ≥ 18 years old;
• • 3. Cohort 1: NSCLC; EGFR wild-type and negative for ALK or ROS1 fusion genes. Cohort 1a: Non-squamous NSCLC (NSQ-NSCLC); Cohort 1b: Squamous NSCLC (SQ-NSCLC); Cohort 2: Breast cancer, negative for ER, PR, and HER-2. Definition of negative for ER and PR: IHC ER \< 1%, IHC PR \< 1%. Definition of negative for HER-2: IHC HER-2 (-) or (1+); for HER-2 (2+), FISH testing must be performed and the result must be negative;
• • 4. Cohort 1: Previous systemic treatment for advanced NSCLC has not been received. If neoadjuvant and/or adjuvant treatment was previously received, the time from the completion of neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for NSCLC; Cohort 2: Previous systemic treatment for advanced TNBC has not been received. If neoadjuvant and/or adjuvant treatment included taxane-based anti-tumor treatment, the time from the completion of taxane-based neoadjuvant and/or adjuvant treatment to the occurrence of recurrence/metastasis must be ≥ 12 months; Patients enrolled in the safety run-in period have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment for TNBC;
• • 5. ECOG score of 0 or 1;
• • 6. Have measurable lesions (according to RECIST 1.1).
• • 7. Expected survival ≥ 12 weeks;
• • 8. Provide archival tumor tissue samples or newly obtained needle biopsy or surgical resection samples of tumor lesions (previously unirradiated) for central PD-L1 and other biomarker tests. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred over slides. Newly obtained biopsy samples are preferred over archival samples. Formalin-fixed samples are preferred after the subject is diagnosed with metastatic disease. If a recent biopsy is not feasible, biopsy samples obtained prior to adjuvant/neoadjuvant chemotherapy are acceptable.
• • 9. Upon signing the ICF, females of childbearing potential and males must agree to practice effective contraception during the study and for 6 months after the last dose, and females of childbearing potential must have a negative result for pregnancy test within 3 days pre-dose;
• Exclusion Criteria:
• • 1. Received approved or investigational anti-tumor treatments within 4 weeks prior to the start of study treatment
• • 2. Received nonspecific immunomodulatory treatments within 2 weeks prior to the start of study treatment;
• • 3. Previously received any antibody or inhibitor targeting PD-1/PD-L1 or VEGF;
• • 4. Laboratory abnormalities
• • 5. History of pulmonary fibrosis or current presence of severe pulmonary functional impairment
• • 6. Uncontrolled chronic disease
• • 7. Unresolved toxicity
• • 8. Uncontrolled brain metastases
• • 9. Active infection
• • 10. Bleeding Risk