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

NCT ID: NCT06746870

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-12-31

Brief Summary

This is a single-arm, multicenter, open-label Phase II clinical study evaluating the efficacy and safety of IMM2510 in combination with chemotherapy as first-line treatment in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic TNBC.

The target population includes: Cohort 1: Patients with histologically or cytologically confirmed stage IV metastatic or recurrent NSCLC who are EGFR wild-type and negative for ALK or ROS1 fusion genes, and who have not received prior systemic treatment for NSCLC; Cohort 2: Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic TNBC who are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER-2), and who have not received prior systemic treatment for TNBC; This study is divided into two phases. Phase I is the safety run-in period, which will preliminarily explore the safety and PK profile of IMM2510 in combination with chemotherapy in patients with NSCLC or TNBC who have previously failed at least first-line systemic treatment, are intolerant to, or not suitable for first-line systemic treatment, to determine the dose for the combination treatment. Phase II is the expanded enrollment period, which will enroll NSCLC patients (Cohort 1; where Cohort 1a is for NSQ-NSCLC and Cohort 1b is for SQ-NSCLC), or TNBC patients (Cohort 2), according to the dose for the combination treatment determined in Phase I, to further explore the preliminary clinical efficacy, safety, and PK profile of IMM2510 in combination with chemotherapy as first-line treatment in patients with NSCLC or TNBC.

Conditions

NSCLC; TNBC

Keywords

NSCLC; TNBC; IMM2510

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1a

NSQ-NSCLC

Group Type: EXPERIMENTAL

IMM2510

Intervention Type: DRUG

Cohort1:

Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II &: 20 mg/kg, Q3W, intravenous infusion

Cohort2:

Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II &: 20 mg/kg, Q2W, intravenous infusion

Chemotherapy (pemetrexed + cisplatin/carboplatin)

Intervention Type: DRUG

Non-squamous non-small cell lung cancer (NQ-NSCLC): Pemetrexed 500 mg/m2 in combination with carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles, followed by maintenance treatment with pemetrexed

Cohort 1b

SQ-NSCLC

Group Type: EXPERIMENTAL

IMM2510

Intervention Type: DRUG

Cohort1:

Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II &: 20 mg/kg, Q3W, intravenous infusion

Cohort2:

Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II &: 20 mg/kg, Q2W, intravenous infusion

Chemotherapy (paclitaxel + cisplatin/carboplatin)

Intervention Type: DRUG

Squamous non-small cell lung cancer (SQ-NSCLC): Paclitaxel 175 mg/m2 + carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles.

Cohort 2

TNBC

Group Type: EXPERIMENTAL

IMM2510

Intervention Type: DRUG

Cohort1:

Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II &: 20 mg/kg, Q3W, intravenous infusion

Cohort2:

Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II &: 20 mg/kg, Q2W, intravenous infusion

Chemotherapy(Nab-paclitaxel)

Intervention Type: DRUG

Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle.

Interventions

IMM2510

Cohort1:

Phase I #: 10 mg/kg or 20 mg/kg, Q3W, intravenous infusion Phase II &: 20 mg/kg, Q3W, intravenous infusion

Cohort2:

Phase I #: 10 mg/kg or 20 mg/kg, Q2W, intravenous infusion Phase II &: 20 mg/kg, Q2W, intravenous infusion

Intervention Type: DRUG

Chemotherapy (pemetrexed + cisplatin/carboplatin)

Non-squamous non-small cell lung cancer (NQ-NSCLC): Pemetrexed 500 mg/m2 in combination with carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles, followed by maintenance treatment with pemetrexed

Intervention Type: DRUG

Chemotherapy (paclitaxel + cisplatin/carboplatin)

Squamous non-small cell lung cancer (SQ-NSCLC): Paclitaxel 175 mg/m2 + carboplatin (AUC 5-6) or cisplatin (75 mg/m2), intravenous infusion, Q3W, for 4 cycles.

Intervention Type: DRUG

Chemotherapy(Nab-paclitaxel)

Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiying Lu, MD

Role: STUDY_DIRECTOR

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Central Contacts

Qiying Lu, MD

Role: CONTACT

Email: qiying.lu@immuneonco.com

Other Identifiers

IMM2510-003

Identifier Type: -

Identifier Source: org_study_id