Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (NCT07307053) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2)
600 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must meet all of the following inclusion criteria:
✓. 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.
✓. Provision of fresh tumor biopsy tissue is recommended, obtained within 12 weeks prior to the first administration of study treatment, consisting of three core needle biopsy specimens. The biopsy tissue must not have been exposed to any antitumor therapy, systemic anti-infective treatment, or vaccination after collection. Peripheral blood samples are also recommended for molecular profiling and enrollment screening.
✓. Provision of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary lesion or a metastatic lesion (excluding bone metastases and lesions previously treated with radiotherapy) obtained within the past 2 years is recommended. The required material includes 15-20 unstained slides (4-6 μm thickness), of which 5 slides should be adhesive-coated and baked. If the above requirements cannot be met, enrollment eligibility may be determined at the investigator's discretion.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to approximately 2 years.
Trial details
NCT IDNCT07307053
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
✓. If pleural or peritoneal effusion is present, samples must be collected for pathological cytological examination, and provision of at least 50 mL of effusion fluid is recommended, if available.
Exclusion criteria
✕. 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.
✕. Major surgery performed within 4 weeks prior to the first administration of study treatment, or surgical wounds that have not fully healed.
✕. History of hypersensitivity reactions to drugs whose chemical structures are similar to the active or inactive components of the investigational antitumor novel drug or technology, or to agents of the same class.
✕. Active infection requiring systemic therapy (e.g., antibiotics), or the presence of any of the following conditions:
✕. Evidence of severe or uncontrolled systemic disease, as determined by the investigator, including but not limited to severe psychiatric or neurological disorders (such as epilepsy or dementia), unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease, or uncontrolled hypertension (defined as blood pressure remaining at or above CTCAE Grade 3 despite medical treatment).