DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

Tianjin Medical University Second Hospital

Status: Enrolling

Conditions: Individuation; Solid Tumor

Treatments: Other: Recommended treatment plan

Study type: Observational

Funder types: Other

Identifiers

NCT06009835

DOTr/DOTa for Solid Tumor

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Treatment group based on DOTr/DOTA detection result

Description:

Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility

Treatment:

Other: Recommended treatment plan