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Advanced Solid TumorsPhase 1NCT03910530

A Study of INCMGA00012, INCB001158, and the Combination in Japanese Participants With Advanced Solid Tumors

A Phase 1 study testing Retifanlimab, INCB001158 and Retifanlimab + INCB001158 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Incyte Biosciences Japan GK at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Retifanlimab, INCB001158 and Retifanlimab + INCB001158
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesJapan
Study dates
22 Jul 2019to 14 Dec 2021
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

  • Participant is Japanese
  • Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy.
  • Participants with nonevaluable lesions are allowed.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
  • Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
  • Male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study.

Who cannot join

  • Receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas; 7 days for tyrosine kinase inhibitors.
  • Radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy.
  • Toxicity of prior therapy and/or complications from surgical intervention that has not recovered to ≤ Grade 1 or baseline within 7 days before starting study drug treatment (with the exception of anemia not requiring transfusion support and any grade of alopecia). Note: Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
  • Receipt of prior systemic treatment with an arginase inhibitor
  • Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
  • Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
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  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection.
  • Known HIV infection.
  • Active infections requiring systemic therapy.
  • Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity ≥ Grade 3, or severe reaction, to study treatments or any of their excipients or additives.
  • Participants with impaired cardiac function or clinically significant cardiac disease.
  • Evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease.
  • Participant is pregnant or breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center Hospital

    Chūōku, 1040045

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

Other trials in Japan

About this study

Official title: A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

Being tested
Retifanlimab, INCB001158, Retifanlimab + INCB001158
Keywords
Advanced solid tumors, metastatic solid tumors, INCMGA00012, INCB001158, Japan, PD-1 Inhibitor, Arginase Inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Also called INCMGA00012

    Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.

  • INCB001158Drug

    Part 1: INCB001158 75 or 100 mg twice daily administered orally.

  • Retifanlimab + INCB001158Drug

    Also called INCMGA00012

    Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .

Study groups in NCT03910530
Study groupRoleWhat they receive
INCMGA00012ExperimentalSingle-agent INCMGA00012.
Receives: Drug: Retifanlimab
INCB001158 75 mgExperimentalSingle-agent INCB001158.
Receives: Drug: INCB001158
INCB001158 100 mgExperimentalSingle-agent INCB001158.
Receives: Drug: INCB001158
INCMGA00012 + INCB001158ExperimentalCombination of INCMGA00012 and INCB001158.
Receives: Drug: Retifanlimab + INCB001158

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012

    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to approximately 2 years

  2. Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCB001158

    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to approximately 2 years

  3. Part 2: Number of treatment-emergent adverse events in participants receiving INCB001158 in combination with INCMGA00012

    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

    Measured: Up to approximately 2 years

Secondary outcomes (24)

  1. Part 1: Cmax of single-agent INCMGA000012

    Maximum observed plasma or serum concentration.

    Measured: Up to 15 days

  2. Part 1: Cmax of single-agent INCB001158

    Maximum observed plasma or serum concentration.

    Measured: Up to 15 days

  3. Part 1: Tmax of single-agent INCMGA000012

    Time to maximum concentration.

    Measured: Up to 15 days

  4. Part 1: Tmax of single-agent INCB001158

    Time to maximum concentration.

    Measured: Up to 15 days

  5. Part 1: Cmin of single-agent INCMGA000012

    Minimum observed plasma or serum concentration over the dose interval.

    Measured: Up to 15 days

  6. Part 1: Cmin of single-agent INCB001158

    Minimum observed plasma or serum concentration over the dose interval.

    Measured: Up to 15 days

  7. Part 1: AUCt of single-agent INCMGA000012

    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

    Measured: Up to 15 days

  8. Part 1: AUCt of single-agent INCB001158

    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

    Measured: Up to 15 days

  9. Part 1: t½ of single-agent INCMGA000012

    Apparent terminal-phase disposition half-life.

    Measured: Up to 15 days

  10. Part 1: t½ of single-agent INCB001158

    Apparent terminal-phase disposition half-life.

    Measured: Up to 15 days

  11. Part 2: Cmax of INCMGA00012 and INCB001158 as a combination treatment

    Maximum observed plasma or serum concentration.

    Measured: Up to 15 days

  12. Part 2: Tmax of INCMGA00012 and INCB001158 as a combination treatment

    Time to maximum concentration.

    Measured: Up to 15 days

  13. Part 2: Cmin of INCMGA00012 and INCB001158 as a combination treatment

    Minimum observed plasma or serum concentration over the dose interval.

    Measured: Up to 15 days

  14. Part 2: AUCt of INCMGA00012 and INCB001158 as a combination treatment

    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

    Measured: Up to 15 days

  15. Part 2: t½ of INCMGA00012 and INCB001158 as a combination treatment

    Apparent terminal-phase disposition half-life.

    Measured: Up to 15 days

  16. Part 1 and Part 2: Overall response rate with single-agent INCMGA00012

    Defined as the percentage of participants experiencing a partial response (PR) or complete response (CR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to 2 years

  17. Part 1 and Part 2: Overall response rate with single-agent INCB001158

    Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.

    Measured: Up to 2 years

  18. Part 1 and Part 2: Overall response rate with INCMGA00012 in combination with INCB001158

    Defined as the percentage of participants experiencing a PR or CR as determined by the investigator according to RECIST v1.1.

    Measured: Up to 2 years

  19. Part 1 and Part 2: Disease control rate with single-agent INCMGA00012

    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

    Measured: Up to 2 years

  20. Part 1 and Part 2: Disease control rate with single-agent INCB001158

    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

    Measured: Up to 2 years

  21. Part 1 and Part 2: Disease control rate with INCMGA00012 in combination with INCB001158

    Defined as the number of participants maintaining either an overall response rate or stable disease according to RECIST v1.1.

    Measured: Up to 2 years

  22. Part 1 and Part 2: Duration of response with single-agent INCMGA00012

    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

    Measured: Up to 2 years

  23. Part 1 and Part 2: Duration of response with single-agent INCB001158

    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

    Measured: Up to 2 years

  24. Part 1 and Part 2: Duration of response with INCMGA00012 in combination with INCB001158

    Defined as the time from first observed response until onset of disease progression according to RECIST v1.1 or death due to any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study start22 Jul 2019
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910530
Sponsor's protocol ID
INCMGA 0012-104
Status last verified
Feb 2022
First submitted
9 Apr 2019
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Retifanlimab, INCB001158 and Retifanlimab + INCB001158 in people with Advanced Solid Tumors and Metastatic Solid Tumors, run by Incyte Biosciences Japan GK at 2 sites in Japan.

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 8 inclusion and 14 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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?

Part 1: Number of treatment-emergent adverse events in participants receiving single-agent INCMGA00012 (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. 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 NCT03910530.

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 25 Feb 2022.

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