NCT06746870

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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
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.
DRUG	Chemotherapy(Nab-paclitaxel)	Nab-paclitaxel, 100 mg/m2, 4 weeks as a cycle, administered on D1, 8, and 15 of each cycle.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-11-01
• Completion: 2026-12-01
• First posted: 2024-12-24
• Last updated: 2024-12-24