Solid TumorPhase 1NCT03164603
NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
A Phase 1 study testing NLG802 in people with Solid Tumor, run by NewLink Genetics Corporation at 3 sites in United States.
Trial summary
This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- NLG802
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2017to 25 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and organ function
Who cannot join
- Active or history of medically significant autoimmune disease
- Cytotoxic therapy or investigational agent use within 28 days
- Human immunodeficiency virus (HIV), active hepatitis B or C
- Untreated brain metastases
- Known QT interval prolongation
- Use of concomitant medications with high risk of causing Torsades des Pointes.
- Use of immune suppressive agents within 30 days
- More than one active malignancy at the time of enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
University of Florida
Gainesville, Florida, 32610
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors
This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.
- Conditions
- Solid Tumor
- Being tested
- NLG802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NLG802Drug
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| NLG8021 Dose Escalation | Experimental | Approximately 6 to 36 participants will be enrolled and treated at escalating doses of NLG802. Treatment may continue until unacceptable toxicity or disease progression. Successive groups of at least 3 participants will be evaluated during a 28-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage. Receives: Drug: NLG802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with dose-limiting toxicities
Measured: 28 Days
Percentage of patients with adverse events
Measured: From Screening until 30 days after last dose (up to approximately 2 years)
Secondary outcomes (3)
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Measured: 21 Days
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator
Measured: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Percentage of Participants With Progression Free Survival (PFS)
equals date of progression/death - date of study enrollment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start29 Jun 2017
- Primary completion1 Apr 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164603
- Sponsor's protocol ID
- NLG8021
- Status last verified
- Jun 2020
- First submitted
- 22 May 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03164603
- Acronym / sponsor ID
- NLG8021
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 23 May 2017 (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 an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NLG8021 Dose Escalation | Experimental | Drug: NLG802Approximately 6 to 36 participants will be enrolled and treated at escalating doses of NLG802. Treatment may continue until unacceptable toxicity or disease progression. Successive groups of at least 3 participants will be evaluated during a 28-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic and organ function
Key exclusion criteria (8 listed)
- Active or history of medically significant autoimmune disease
- Cytotoxic therapy or investigational agent use within 28 days
- Human immunodeficiency virus (HIV), active hepatitis B or C
- Untreated brain metastases
- Known QT interval prolongation
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 |
|---|---|---|
| NLG802Indoleamine 2,3-Dioxygenase (IDO) Inhibitor | Drug | NLG8021 Dose Escalation |
Primary outcome
Percentage of patients with dose-limiting toxicities
Time frame: 28 Days
Percentage of patients with adverse events
Time frame: From Screening until 30 days after last dose (up to approximately 2 years)
3 secondary outcomes
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: 21 Days
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator
Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Percentage of Participants With Progression Free Survival (PFS)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NLG802 in people with Solid Tumor, run by NewLink Genetics Corporation at 3 sites in United States.
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 8 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: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with dose-limiting toxicities (time frame: 28 Days). 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 4 Jun 2020.