MedTrace Logo

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

NCT06746870 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-12-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

    lead OTHER

Principal Investigators

  • Qiying Lu, MD · ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-11-30
Completion
2026-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746870 on ClinicalTrials.gov