DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009835
• Other study ID #: DOTr/DOTa for Solid Tumor
• Status: Recruiting
• Start date: August 7, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Tianjin Medical University Second Hospital
• Contact: HaiTao Wang, Ph.D
• Phone: +86-022-88326385
• Email: peterrock2000[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 1, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical Unversity Second Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Second Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, an expected average of 2year
Secondary	ORR	Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens	Through study completion, an expected average of 1 year
Secondary	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	Through study completion, an expected average of 1 year
Secondary	AEs	Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0	Through study completion, an expected average of 1 year