KEY TAKEAWAYS
- The HLX07Ib/II phase I/II trial aimed to evaluate the safety and efficacy of HLX07 in combination with chemotherapy for advanced solid tumors.
- The primary endpoints were DLTs and MTDs. The secondary endpoint included safety and preliminary efficacy.
- The study found that a combination of HLX07 and chemotherapy was well-tolerated in advanced solid tumor pts.
HLX07 is a monoclonal antibody that is designed to block the EGFR protein. Researchers aimed to evaluate the safety and efficacy of HLX07 in combination with chemotherapy for advanced solid tumors.
The study included patients(pts) with metastatic or recurrent advanced solid tumors suitable for treatment with the chemo-regimens of gemcitabine 1,000 mg/m2 (on Days 1 and 8) and cisplatin 75 mg/m2 (on Day 1) in 3-week cycles for 4–6 cycles; paclitaxel 80 mg/m2 and carboplatin AUC = 2 (both on Days 1, 8, and 15) in 3-week cycles for 4–6 cycles; and 3) mFOLFOX6 (on Day 1) in 2-week cycles for 6–12 cycles, were administered HLX07 IV at escalating doses (400, 600, or 800 mg, QW) combined with the respective chemotherapy regimens following BOIN design. The study’s primary endpoints were dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of HLX07. Secondary endpoints included safety and preliminary efficacy.
The study enrolled 56 pts; 21 received HLX07 with gemcitabine and cisplatin, 21 received HLX07 with paclitaxel and carboplatin (n = 3 for HLX07 400 mg, n = 3 for HLX07 600 mg, and n = 15 for HLX07 800 mg for each chemo-regimen), and 14 received HLX07 with mFOLFOX6 (n = 3 for HLX07 400 mg, n = 3 for HLX07 600 mg, and n = 8 for HLX07 800 mg). No DLT related to HLX07 was reported. The MTD was not reached. All pts experienced TEAEs. Grade ≥3 TEAEs were reported by 17 (81.0%), 20 (95.2%), and 12 (85.7%) pts in each chemo-regimen group, respectively. Only 1 (33.3%) patient in the HLX07 400 mg plus paclitaxel and carboplatin group experienced a TEAE leading to death (upper gastrointestinal hemorrhage, possibly unrelated to study drugs).
The study found that a combination of HLX07 and chemotherapy was well-tolerated in advanced solid tumor pts.
Source: https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e15001
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03577704
Qun Li, Ye Guo, Junli Xue, Xiaoxiao Ge, Fengjuan Lin, Liqiong Xue, Wei Zhao, Wenbo Tang, Chen Hu, Hongyan Ni, Jing Li, Qingyu Wang, Jun Zhu, and Jin Li. DOI: 10.1200/JCO.2023.41.16_suppl.e15001 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e15001-e15001.
