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

NCT06030869 | Unknown

• 1 other identifier: MyCustom for Solid Tumors
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Solid Tumors; Next Generation Sequencing

Keywords

Precision medicine; NGS; Molecular Tumor Board(MTB)

Outcome Measures

Primary Outcomes (1)

• PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)

  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.

  3 years

Secondary Outcomes (4)

• ORR(Objective Response Rate)

  3 years

• OS(Overall Survival)

  3 years

• Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0

  3 years

• Proportion of patients with actionable target

  3 years

Study Arms (3)

Cohort-A: Patients with actionable targets

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.

Cohort-B: Patients with potential actionable targets

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.

Cohort-C: Patients with non-actionable targets

MTB combined with clinical practice and literature reports can not match the gene alteration of targeted therapy, which is considered as an irreversible gene alteration.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• 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;
• ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4));
• Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments;
• Signed, written informed consent to participate.

You may not qualify if:

• Suitable for standard therapy;
• Specific contraindications to exposure to the investigationalproducts;
• 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;
• Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer;
• Pregnancy, lactation or inadequate contraception.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Study Officials

• Haitao Wang, Ph.D

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326610; peterrock2000@126.com

Lili Wang, M. Med.

CONTACT

+86-022-88326610; 412526928@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 11, 2023
• Study Start: December 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CN (1)