MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors

Recruiting

• Conditions: Next Generation Sequencing; Refractory Solid Tumors

• Registration Number: NCT06030869
• Lead Sponsor: Tianjin Medical University Second Hospital

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.

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Last Update Submitted: 2023-09-02
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)	3 years	The time to progression-free survival during the substudy (PFS2) exceeds the documented time to disease progression-free survival during the last treatment prior to substudy entry (PFS1) by at least 35% (ie, PFS2/PFS1≥1.3) or, if PFS1 is not evaluable, time to progressive disease exceeds 6 months.

Secondary Outcome Measures

Name	Time	Method
OS(Overall Survival)	3 years	Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date.
Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0	3 years	Treatment related adverse events with grade 3 or greater severity by CTCAE 5.0.
ORR(Objective Response Rate)	3 years	Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Proportion of patients with actionable target	3 years	Number of patients with modifiable genomic variants.

Trial Locations

Locations (1)

Tianjin Medical University Second Hospital; 🇨🇳 Tianjin, Tianjin, China