DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

Recruitment Status: STATUS NOT REPORTED
(See Contacts and Locations)Verified July 2023 by Tianjin Medical University Second Hospital
Sponsor: Tianjin Medical University Second Hospital
Information Provided by (Responsible Party): Tianjin Medical University Second Hospital

Clinicaltrials.gov Identifier: NCT06009835
Other Study ID Numbers:: DOTr/DOTa for Solid Tumor

First Submitted: August 18, 2023
First Posted: August 23, 2023
Last Update Posted: August 23, 2023
Last Verified: July 2023

ClinicalTrials.gov processed this data on August 2023. Link to the current ClinicalTrials.gov record .

Study Details

Study 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).

Condition or Disease	Intervention/Treatment
Solid TumorIndividuation	Other: Recommended treatment plan

Study Design

Study Type	Observational
Actual Enrollment	15 participants
Official Title	An Open, Single Center Clinical Study Based on DarwinOncoTreatTM (DOTr) and DarwinOncoTargetTM (DOTa) Algorithm Guidance for Treating Solid Tumor Patients Who Are Exhausted or Unable to Tolerate Standard Treatment Regimens
Study Start Date	August 6, 2022
Actual Primary Completion Date	August 6, 2024
Actual Study Completion Date	August 31, 2024

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures

Feasibility of selecting treatment plans based on DOTr/DOTA result
The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test

Secondary Outcome Measures

ORR
Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens
PFS2/PFS1
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
AEs
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

Eligibility Criteria

Ages Eligible for Study	(Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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.

Contacts and Locations

Sponsors and Collaborators	Tianjin Medical University Second Hospital
Locations	Tianjin Medical Unversity Second Hospital \| Tianjin Tianjin Municipality, China,
Investigators	Principal Investigator: HaiTao Wang, Ph.D, Tianjin Medical University Second Hospital

More Information

Publications

Mundi PS, Dela Cruz FS, Grunn A, Diolaiti D, Mauguen A, Rainey AR, Guillan K, Siddiquee A, You D, Realubit R, Karan C, Ortiz MV, Douglass EF, Accordino M, Mistretta S, Brogan F, Bruce JN, Caescu CI, Carvajal RD, Crew KD, Decastro G, Heaney M, Henick BS, Hershman DL, Hou JY, Iwamoto FM, Jurcic JG, Kiran RP, Kluger MD, Kreisl T, Lamanna N, Lassman AB, Lim EA, Manji GA, McKhann GM, McKiernan JM, Neugut AI, Olive KP, Rosenblat T, Schwartz GK, Shu CA, Sisti MB, Tergas A, Vattakalam RM, Welch M, Wenske S, Wright JD, Canoll P, Hibshoosh H, Kalinsky K, Aburi M, Sims PA, Alvarez MJ, Kung AL, Califano A. A Transcriptome-Based Precision Oncology Platform for Patient-Therapy Alignment in a Diverse Set of Treatment-Resistant Malignancies. Cancer Discov. 2023 Jun 2;13(6):1386-1407. doi: 10.1158/2159-8290.CD-22-1020.