Advanced Solid TumorsPhase 1NCT03641794
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
A Phase 1 study testing DN1406131 in people with Advanced Solid Tumors, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- DN1406131
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2018to 31 Jul 2019
- Phase
- Phase 1
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age greater of 18 years and less than 45
- Weight ≥50 kg,body mass index of 19~26 kg/m2
- Signed ICF
Who cannot join
- active autoimmune disease
- uncontrolled concurrent illness
- Smoking
- Drugs
- positive serology for HIV, Hepatitis B or C,Syphilis
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PKUCare Luzhong Hospital
Zibo, Shandong, 255000
About this study
Official title: A Phase I Study of DN1406131 in Healthy Adults
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
- Conditions
- Advanced Solid Tumors
- Being tested
- DN1406131, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN1406131Drug
IDO1 and TDO2 inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DN1406131 | Experimental | 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg Receives: Drug: DN1406131 |
| Placebo | Placebo comparator | 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events - type, incidence, severity
Evaluate the safety and toxicity of DN1406131 in healthy volunteers
Measured: 28 day
Maximum Tolerated Dose
To define the Maximum Tolerated Dose (MTD)
Measured: 14 day
Secondary outcomes (4)
Peak Plasma Concentration (Cmax)
Cmax
Measured: 48 hours
Serum for biomarkers of IDO activity (kynurenine and tryptophan)
Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy.
Pharmacodynamics（PD）
Measured: 48 hours
Elimination half-life
T1/2
Measured: 48 hours
peak time
Tmax
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start7 Sep 2018
- Primary completion13 May 2019
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai De Novo Pharmatech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, Study director, Jiangxi Qingfeng Pharmaceutical Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641794
- Sponsor's protocol ID
- DN-DN1406131-101
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of DN1406131 in Healthy Adults
- ClinicalTrials.gov ID
- NCT03641794
- Acronym / sponsor ID
- DN-DN1406131-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai De Novo Pharmatech Co., Ltd.
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 22 Aug 2018 (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 is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DN1406131 | Experimental | Drug: DN140613125 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg |
| Placebo | Placebo comparator | Drug: Placebo25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age greater of 18 years and less than 45
- Weight ≥50 kg,body mass index of 19~26 kg/m2
- Signed ICF
Key exclusion criteria (6 listed)
- active autoimmune disease
- uncontrolled concurrent illness
- Smoking
- Drugs
- positive serology for HIV, Hepatitis B or C,Syphilis
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 |
|---|---|---|
| DN1406131IDO1 and TDO2 inhibitor | Drug | DN1406131 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
adverse events - type, incidence, severity
Time frame: 28 day
Evaluate the safety and toxicity of DN1406131 in healthy volunteers
Maximum Tolerated Dose
Time frame: 14 day
To define the Maximum Tolerated Dose (MTD)
4 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
Serum for biomarkers of IDO activity (kynurenine and tryptophan)
Time frame: 48 hours
Elimination half-life
Time frame: 48 hours
peak time
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Qinghong Zhou study director
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DN1406131 in people with Advanced Solid Tumors, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. 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 3 inclusion and 6 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 1 Aug 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wanwan Ji (18852605644, jiwanwan@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events - type, incidence, severity (time frame: 28 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2019.