Clinical trial · Observational
MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors
MyCustom:A Framework for Prospective and Master Protocol Trial of Precise Drug Treatment for Refractory Solid Tumors
NCT06030869CI-TRIAL-00069485unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Next Generation Sequencing | — | UNRESOLVED | — |
| Refractory Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Cohort-A: Patients with actionable targets
- description
- In the OncoKB(Precision Oncology Knowledge Base) database, the gene alteration has a variant of clinical evidence in this tumor or other tumor types and is considered to be an interventional variant. Cohort-A may include different observation subgroups. For example, substudy-A1: monotherapy/combination therapy for patients with A1-relative. Substudy-Ax: monotherapy/combination therapy for patients with Ax-relative.
- label
- Cohort-B: Patients with potential actionable targets
- description
- In cohort-B, the gene alteration that MTB combines with clinical practice and literature reports that can match targeted therapy is considered to be potential actionable targets. Cohort-B also includes different observation subgroups and clinical trials may conduct in each subgroup. For example, substudy-B1(TP53 as driver gene), substudy-B2(RAS as driver gene), substudy-B3(MAP2K1 as driver gene), substudy-B4(PTEN Loss as driver gene), substudy-B5(11q13 co-amplification as driver genes), Substudy-B6(concomitant actionable alterations), substudy-B7(other driver genes). MTB-guided therapy was defined as having a clinical benefit if the PFS ratio between the longest PFS on MTB-guided therapy and the PFS on the last therapy before MTB-guided therapy was ≥1.3 (i.e., using patients as their own controls) for each substudy. 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.
- label
- Cohort-C: Patients with non-actionable targets
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.