DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

Recruiting

• Conditions: Solid Tumor; Individuation
• Interventions: Other: Recommended treatment plan

• Registration Number: NCT06009835
• Lead Sponsor: Tianjin Medical University Second Hospital

Brief Summary

This study is an open, single center clinical study targeting solid tumor patients who have exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on DOTr/DOTa results for solid tumor patients who have exhausted or cannot tolerate standard treatment regimens.

Detailed Description

Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which identifies drugs that invert the transcriptional activity of hyperconnected MR modules, produced highly significant 30-day disease control rates (68% and 91%, respectively).

Study Timeline

• Study Start: 2022-08-07
• Status Verified: 2023-08
• Study First Submitted: 2023-08-19
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2024-08-07
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. The subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form;
2. Patients aged ≥ 18 years old;
3. Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
4. According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
5. ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
6. The expected survival period is not less than 12 weeks;
7. Women of childbearing age must have a Pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug;
8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
9. If the main organs function normally, they meet the following standards:

The blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥ 50%.

Exclusion Criteria

1. Severe heart disease or discomfort that cannot be treated;
2. Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
3. Pregnant or lactating female patients;
4. Participating in other clinical trials at the same time;
5. Researchers believe that individuals are not suitable for enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group based on DOTr/DOTA detection result	Recommended treatment plan	Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility

Primary Outcome Measures

Name	Time	Method
Feasibility of selecting treatment plans based on DOTr/DOTA result	Through study completion, an expected average of 2year	The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test

Secondary Outcome Measures

Name	Time	Method
ORR	Through study completion, an expected average of 1 year	Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens
AEs	Through study completion, an expected average of 1 year	Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
PFS2/PFS1	Through study completion, an expected average of 1 year	he progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment; The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death

Trial Locations

Locations (1)

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