A Phase 1 Study to evaluate tolerability, safety and efficacy of AB122 and AB154 in Combination with Chemotherapy for Patients With Non-Small Cell Lung Cancer

JRCT ID: jRCT2051230009

Registered date:11/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer
• Date of first enrollment: 01/05/2023
• Target sample size: 12
• Study type: Interventional

Intervention(s)

Arm 1
- AB122: 360 mg will be administered intravenously once every 3 weeks.
- AB154: 1200 mg will be administered intravenously once every 3 weeks.
- Paclitaxel: 200 mg/m2 will be administered intravenously once every 3 weeks.
- Carboplatin: AUC of 6 (maximum dose 900 mg) will be administered intravenously once every 3 weeks.

Arm 2
- AB122: 360 mg will be administered intravenously once every 3 weeks.
- AB154: 1200 mg will be administered intravenously once every 3 weeks.
- Nab-Paclitaxel: 100 mg/m2 will be administered intravenously weekly (Days 1, 8, and 15 of each cycle).
- Carboplatin: AUC of 6 (maximum dose 900 mg) will be administered intravenously once every 3 weeks.

Arm 3
- AB122: 360 mg will be administered intravenously once every 3 weeks.
- AB154: 1200 mg will be administered intravenously once every 3 weeks.
- Pemetrexed: 500 mg/m2 will be administered intravenously once every 3 weeks.
- Carboplatin: AUC of 5 (maximum dose 750 mg) will be administered intravenously once every 3 weeks.

Arm 4
- AB122: 360 mg will be administered intravenously once every 3 weeks.
- AB154: 1200 mg will be administered intravenously once every 3 weeks.
- Pemetrexed: 500 mg/m2 will be administered intravenously once every 3 weeks.
- Cisplatin 75 mg/m2 will be administered intravenously once every 3 weeks.

Outcome(s)

• Primary Outcome: DLT occurrence rate during Cycle 1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Age of 18 or older at the time of informed consent
- Japanese male or female participant
- Life expectancy >= 3 months.
- Pathologically documented NSCLC and evidence of Stage IV NSCLC disease at the time of enrollment.
- Have not received prior systemic treatment for metastatic NSCLC.
- Measurable disease by CT or MRI as per RECIST v1.1 criteria by investigator assessment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Have adequate organ functions

Exclude criteria

- Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
- Has known actionable genomic alterations in EGFR gene mutation, ALK fusion gene, ROS1 fusion gene, BRAF gene mutation, MET exon 14 skipping, NTRK fusion gene, RET fusion gene, or KRAS gene mutation.
- Pregnant or breastfeeding women (including those who have interrupted breastfeed).
- Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
- Have an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
- Has a history of noninfectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Have received a live-virus vaccination within 30 days of planned treatment start (Cycle 1 Day 1). Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Have known acute or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Related Information

• Primary Sponsor: Nasermoaddeli Ali