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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2026

Conditions
NSCLCTNBC
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.

All Listed Sponsors
lead

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

OTHER