Clinical trial NCT06030869: MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors
Official title: MyCustom:A Framework for Prospective and Master Protocol Trial of Precise Drug Treatment for Refractory Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractory Solid Tumors
Next Generation Sequencing
Keywords: Precision medicine
NGS
Molecular Tumor Board(MTB)
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients have an advanced or metastatic solid tumor, multiple cancers(including but not limited to small cell lung cancer, gastric cancer, prostate cancer, bladder cancer, and head and neck squamous cell carcinoma) standard treatment options are no longer available or lack effective treatments.

Brief summary: The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The target population covers a variety of solid advanced malignant tumors, including but not limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck squamous carcinoma or lacking effective treatment after standard treatment failure.

Detailed description: The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven "basket" (tissue-type agonistic) study. The target population covers a variety of solid advanced malignant tumors, including but not limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck squamous carcinoma or lacking effective treatment after standard treatment failure.The overall goal is to develop a more effective research method to test new individualized treatment hypotheses.This study will provide comprehensive theoretical and practical support for individualized custom model in refractory solid tumors.Archival pathology laboratory samples from patients with treatment-refractory advanced solid cancer of any histologic type undergo Next Gene Sequencing(NGS) analysis.Fllowing obtain the raw data of the patient's gene sequencing, the data are analyzed by the auxiliary decision algorithm to obtain the prioritization results of the drugs matched by this patient.The results are subsequently reviewed by the Molecular Tumor Board (MTB), where eligible patients can be treated in treatment substudies.All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including clinical efficacy ,clinical safety and exploratory endpoints such as biomarkers for drug response, change in the tumor microenvironment. For some clinical studies, to meet the primary objective, at least 35% of participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable patients. sample size was calculated using an exact single-stage design for phase II studies with a one-sided type I error of 5% and a power of 90% under the assumption that PF2S/PFS1≥ 1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would merit further investigation.

Eligibility criteria: Inclusion Criteria:

1. Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid cancer of any histological type, or an earlier diagnosis of cancer with a poor prognosis. Suffificient accessible tissue for molecular profifiling;
2. Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
3. ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4));
4. Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments;
5. Signed, written informed consent to participate.

Exclusion Criteria:

1. Suitable for standard therapy;
2. Specific contraindications to exposure to the investigationalproducts;
3. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol;
4. Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer;
5. Pregnancy, lactation or inadequate contraception.

Primary outcomes:
measure: PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)
timeFrame: 3 years
Secondary outcomes:
measure: ORR(Objective Response Rate)
timeFrame: 3 years
measure: OS(Overall Survival)
timeFrame: 3 years
measure: Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
timeFrame: 3 years
measure: Proportion of patients with actionable target
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Second Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Haitao Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: