DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Individuation
• Intervention / Treatment: Other: Recommended treatment plan

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 Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Haitao Wang, Ph.D; Phone Number: +86-022-88326385; Email: peterrock2000@126.com
• Study Contact Backup: Name: Lili Wang, Ph.D; Phone Number: +86-022-88326610; Email: wangliliaigang@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical Unversity Second Hospital
      • Contact: Haitao Wang, Ph.D; Phone Number: +86-022-88326385; Email: peterrock2000@126.com
      • Sub-Investigator: Lili Wang
      • Sub-Investigator: Dingkun Hou
      • Principal Investigator: Haitao Wang
      • Sub-Investigator: Jinhuan Wang
      • Contact: Lili Wang, MM; Phone Number: +86-022-88326610; Email: wangliliaigang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Second Hospital
• Investigators: Principal Investigator: Haitao Wang, Ph.D, Tianjin Medical University Second Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2022
• Primary Completion (Estimated): August 7, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 19, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DOTr/DOTa for Solid Tumor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No