Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06194656
Brief Summary:
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up.
Detailed Description:
This phase II study will be conducted in two parts (Ⅱa and Ⅱb), with a 21-day treatment cycle until disease progression, intolerable toxicity, withdrawal of informed consent, death, initiation of new anti-tumor treatment or loss of follow-up. The participants in both study parts are the same, both of whom were patients with recurrent/metastatic advanced HNSCC (non nasopharyngeal carcinoma).
* a is an open-label study. Part one, 12 subjects were randomly assigned 1:1 to two groups and treated with SIBP-03 dose A or dose B every 3 weeks (Q3W) combined with cetuximab every week (QW). Part two, 3 subjects were treated with SIBP-03 dose C Q3W combined with cetuximab QW. If 1/3 subjects (1 case) have DLT, 3 more subjects need to continue to observe the safety and tolerance; If DLT occurs in 3 cases or ≥ 2 cases in 6 cases, the sponsor and the researcher will discuss and decide whether to terminate this part of the study or change the dose. 12 subjects were added at most.
* b is a randomized, double-blind study. Including an experimental group (RP2D) and a placebo control group. The qualified subjects in this stage will be randomly assigned according to the ratio of 2: 1, including 38 cases in the experimental group and 19 cases in the control group, with a total of 57 subjects.
Study:
NCT06194656
Study Brief:
Protocol Section:
NCT06194656