Advanced MalignanciesPhase 1/2NCT02923349
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing INCAGN01949 in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 8 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Metastatic Cancer
- What is being tested?
- INCAGN01949
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 31 Oct 2016to 26 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
- Part 1: Subjects with advanced or metastatic solid tumors.
- Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
- Presence of measureable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group performance status 0 or 1.
Who cannot join
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study drug.
- Active autoimmune disease that required systemic treatment in the past.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
New York University Clinical Cancer Center
New York, New York, 10016
United Kingdom2 sites
University College Hospital
London, NW1 2PG
University of Oxford
Oxford, OX3 7LE
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Being tested
- INCAGN01949
- Keywords
- Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody
- Medical subject headings
- Neoplasm Metastasis, Ovarian Neoplasms, Carcinoma, Renal Cell, Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN01949Drug
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
| Study group | Role | What they receive |
|---|---|---|
| INCAGN01949 | Experimental | Not described Receives: Drug: INCAGN01949 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Measured: From screening through 60 days after end of treatment, up to 11 months
Secondary outcomes (8)
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Measured: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Measured: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measured: Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measured: Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measured: Baseline and every 8 weeks, up to 11 months
Duration of Disease Control Per RECIST and Modified RECIST
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measured: Baseline and every 8 weeks, up to 11 months
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Measured: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
Measured: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start31 Oct 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced MalignanciesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E. Janik, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923349
- Sponsor's protocol ID
- INCAGN 1949-101
- Other IDs
- 2016-002079-93, 2016
- Status last verified
- Aug 2025
- First submitted
- 3 Oct 2016
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
PubMed 36316061
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02923349
- Acronym / sponsor ID
- INCAGN 1949-101
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Keywords
- Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCAGN01949 | Experimental | Drug: INCAGN01949 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
- Part 1: Subjects with advanced or metastatic solid tumors.
- Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
- Presence of measureable disease based on RECIST v1.1.
Key exclusion criteria (5 listed)
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study drug.
- Active autoimmune disease that required systemic treatment in the past.
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 |
|---|---|---|
| INCAGN01949Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts. | Drug | INCAGN01949 |
Primary outcome
Number of Participants With Treatment-related Adverse Events
Time frame: From screening through 60 days after end of treatment, up to 11 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
8 secondary outcomes
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
Time frame: Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
Time frame: Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
Time frame: Baseline and every 8 weeks, up to 11 months
Duration of Disease Control Per RECIST and Modified RECIST
Time frame: Baseline and every 8 weeks, up to 11 months
Time to Maximum Concentration of INCAGN01949 in Plasma
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Summary of Trough Concentrations(Cmin) of INCAGN01949
Time frame: Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36316061Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
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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.
John E. Janik, MD study director
Incyte Corporation
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCAGN01949 in people with Advanced Malignancies and Metastatic Cancer, run by Incyte Biosciences International Sàrl at 8 sites in 4 countries.
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 6 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: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom, Spain, Switzerland. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events (time frame: From screening through 60 days after end of treatment, up to 11 months). 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 NCT02923349, 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 2025.