Solid TumorNCT06009835
DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors
An observational study of Solid Tumor and Individuation, run by Tianjin Medical University Second Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Individuation
- What is being tested?
- Recommended treatment plan
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens
Who may be able to join
- 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;
- Patients aged ≥ 18 years old;
- Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
- According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
- ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
- The expected survival period is not less than 12 weeks;
Show all 10Show fewer
- 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;
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
- 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%.
Who cannot join
- Severe heart disease or discomfort that cannot be treated;
- Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
- Pregnant or lactating female patients;
- Participating in other clinical trials at the same time;
- Researchers believe that individuals are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality
Haitao Wang, Ph.D, +86-022-88326385, peterrock2000@126.com
Lili Wang, MM, +86-022-88326610, wangliliaigang@163.com
About this study
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
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.
Read the 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).
- Conditions
- Solid Tumor, Individuation
- Being tested
- Recommended treatment plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended treatment planOther
Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Recommended treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an expected average of 2year
Secondary outcomes (3)
ORR
Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens
Measured: 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
Measured: 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
Measured: Through study completion, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start7 Aug 2022
- Primary completion7 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HaiTao Wang, Ph.D, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009835
- Sponsor's protocol ID
- DOTr/DOTa for Solid Tumor
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
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.
PubMed 37061969
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06009835
- Acronym / sponsor ID
- DOTr/DOTa for Solid Tumor
- Conditions
- Solid Tumor, Individuation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 7 Aug 2022 (actual)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group based on DOTr/DOTA detection result | – | Other: Recommended treatment planDevelop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens
Key inclusion criteria (10 listed)
- 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;
- Patients aged ≥ 18 years old;
- Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
- According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
- ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
Key exclusion criteria (5 listed)
- Severe heart disease or discomfort that cannot be treated;
- Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
- Pregnant or lactating female patients;
- Participating in other clinical trials at the same time;
- Researchers believe that individuals are not suitable for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommended treatment planDevelop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility | Other | Treatment group based on DOTr/DOTA detection result |
Primary outcome
Feasibility of selecting treatment plans based on DOTr/DOTA result
Time frame: Through study completion, an expected average of 2year
The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test
3 secondary outcomes
ORR
Time frame: Through study completion, an expected average of 1 year
PFS2/PFS1
Time frame: Through study completion, an expected average of 1 year
AEs
Time frame: Through study completion, an expected average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 37061969Mundi 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.
Related trials for Solid Tumor
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
Advanced Solid Tumor (Phase 1)
RecruitingPhase 1
DBC-664 in Adult Patients With Solid Tumors
Malignant Germ Cell Tumor, Lung Adenocarcinoma
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
RecruitingPhase 2
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
Solid Tumors
Recruiting
A Study of a Distress Screening and Referral Program in People With Recently Diagnosed Cancer
Solid Tumor Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HaiTao Wang, Ph.D principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Individuation, run by Tianjin Medical University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HaiTao Wang, Ph.D (+86-022-88326385, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of selecting treatment plans based on DOTr/DOTA result (time frame: Through study completion, an expected average of 2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.