This single-center, Phase 1 study is evaluating the safety, tolerability, and preliminary antitumor activity of recombinant human endostatin adenovirus injection (EDS01) given by intratumoral injection in combination with toripalimab in adults with recurrent or metastatic head and neck tumors, including nasopharyngeal carcinoma, whose disease has progressed after platinum-based systemic therapy or who are not suitable for further platinum treatment.
A total of 9 participants will be enrolled in 3 planned dose groups of EDS01. EDS01 will be injected directly into an accessible tumor lesion on Days 0 and 7, and toripalimab 240 mg will be administered intravenously on Day 1 of each treatment cycle for up to 4 cycles, unless disease progression or unacceptable toxicity occurs. The study will evaluate treatment-related adverse events as well as preliminary efficacy outcomes, including tumor response, disease control, and time to progression, using clinical assessments, laboratory tests, imaging, and follow-up after treatment.
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Single group
EDS01 1.0×10^11 VP + Toripalimab
DrugRecombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
EDS01 5.0×10^11 VP + Toripalimab
DrugRecombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 5.0×10\^11 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
EDS01 1.0×10^12 VP + Toripalimab
DrugRecombinant human endostatin adenovirus injection (EDS01) is administered by intratumoral injection into an accessible tumor lesion on Days 0 and 7 of each 21-day cycle. Three planned dose levels are evaluated across study cohorts: 1.0×10\^12 VP. Treatment may continue for up to 4 cycles unless disease progression or unacceptable toxicity occurs.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events, and clinically significant abnormal laboratory findings. Adverse events will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC), version 4.0. Safety evaluation will also include physical examination findings and environmental shedding monitoring related to intratumoral administration of EDS01.
Objective response rate of target lesions
Proportion of participants with complete response (CR) or partial response (PR) in target lesions. Tumor response will be assessed according to RECIST version 1.1.
Disease control rate of target lesions
Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) in target lesions, assessed according to RECIST version 1.1.
Overall objective response rate of all lesions
Proportion of participants with complete response (CR) or partial response (PR) in overall lesions, assessed according to RECIST version 1.1.
Time to progression (TTP)
Time from enrollment to the first documented disease progression. Deaths before progression will be censored.
Change in serum anti-adenovirus IgG
Change in serum anti-adenovirus (ADV) IgG from baseline to post-baseline assessments, measured by ELISA.
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