The goal of this Phase I/II observational and interventional platform study is to evaluate the safety and efficacy of multiple types of innovative anti-tumor drugs and new technologies in patients with rare solid tumors. The study utilizes multi-dimensional precision screening (including WES, RNAseq, mIHC, and quantitative proteomics) to match patients with specific sub-protocols.
Key questions it aims to answer:
Assess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.
Male or female subjects aged ≥16 years at the time of signing the informed consent form.
Histologically or cytologically confirmed malignancy.
ECOG performance status of 0-2 and an expected survival of more than 12 weeks.
Presence of measurable or evaluable disease for efficacy assessment, as determined by the investigator according to the individualized criteria defined in each sub-protocol.
Prior treatment with any antitumor novel drug or technology of the same class as that investigated in the relevant sub-protocol of this study.
Known hypersensitivity or allergy to any active component or excipient of the investigational antitumor novel drug or technology.
Presence of any type of interstitial lung disease or a history of radiation pneumonitis.
Failure to meet the inclusion or exclusion criteria specified in the applicable sub-protocol.
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Treatment groupsSee each treatment group below.