Cervical CancerPhase 1NCT03652077
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
A Phase 1 study testing INCAGN02390 in people with Cervical Cancer and Gastric Cancer, run by Incyte Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Gastric Cancer, Stomach Cancer
- What is being tested?
- INCAGN02390
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Sep 2018to 18 Aug 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
- Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
- Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Who cannot join
- Laboratory values at screening outside the protocol-defined ranges.
- Administration of colony-stimulating factors within 14 days before Study Day 1.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Receipt of a live vaccine within 30 days of planned start of study drug.
- Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.
- Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Show all 14Show fewer
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Active infection requiring systemic therapy.
- Evidence of active HBV or HCV infection.
- Known history of HIV (HIV 1/2 antibodies).
- Known allergy or reaction to any component of study drug or formulation components.
- Prior treatment with an anti-TIM-3 antibody for any indication.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hackensack Medical Center
Hackensack, New Jersey, 07601
Carolina BioOncology
Huntsville, North Carolina, 28078
University of Mississippi
Jackson, Mississippi, 39216
The Angeles Clinical and Research Institute
Los Angeles, California, 90025
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
- Conditions
- Cervical Cancer, Gastric Cancer, Stomach Cancer, Gastroesophageal Junction Cancer, Esophageal Cancer, Hepatocellular Carcinoma
- Being tested
- INCAGN02390
- Keywords
- Advanced malignancies, immunoglobulin (Ig)G1k monoclonal antibody, T-cell immunoglobulin and mucin domain 3 (TIM-3)
- Medical subject headings
- Uterine Cervical Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Carcinoma, Hepatocellular, Melanoma, Uveal Melanoma, Carcinoma, Merkel Cell, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCAGN02390Drug
Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.
| Study group | Role | What they receive |
|---|---|---|
| INCAGN02390 | Experimental | Not described Receives: Drug: INCAGN02390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to 12 months
Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
Measured: Up to approximately 1 month
Secondary outcomes (10)
Cmax of INCAGN02390
Maximum observed plasma or serum concentration.
Measured: Up to 12 months
Tmax of INCAGN02390
Time to maximum concentration.
Measured: Up to 12 months
Cmin of INCAGN02390
Minimum observed plasma or serum concentration over the dose interval.
Measured: Up to 12 months
AUC0-t of INCAGN02390
Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measured: Up to 12 months
Objective response rate
Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to 12 months
Duration of response
Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression.
Measured: Up to 12 months
Disease control rate
Defined as percentage of participants having CR, PR, or stable disease as best on-study response.
Measured: Up to 12 months
Progression-free survival
Defined as the time from date of first dose of study drug until the earliest date of disease progression (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression.
Measured: Up to 12 months
Level of binding of INCAGN02390 to TIM-3
Assessed from participant whole blood samples.
Measured: Up to approximately 3 months
Immunogenicity of INCAGN02390
Defined as the occurrence of specific ADA to INCAGN02390.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start24 Sep 2018
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nawel Bourayou, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652077
- Sponsor's protocol ID
- INCAGN 2390-101
- Status last verified
- Nov 2021
- First submitted
- 28 Aug 2018
- Last updated
- 15 Nov 2021
- 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 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies
- ClinicalTrials.gov ID
- NCT03652077
- Acronym / sponsor ID
- INCAGN 2390-101
- Conditions
- Cervical Cancer, Gastric Cancer, Stomach Cancer, Gastroesophageal Junction Cancer, Esophageal Cancer, Hepatocellular Carcinoma
- Keywords
- Advanced malignancies, immunoglobulin (Ig)G1k monoclonal antibody, T-cell immunoglobulin and mucin domain 3 (TIM-3)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 29 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.
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCAGN02390 | Experimental | Drug: INCAGN02390 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
- Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Key exclusion criteria (14 listed)
- Laboratory values at screening outside the protocol-defined ranges.
- Administration of colony-stimulating factors within 14 days before Study Day 1.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Receipt of a live vaccine within 30 days of planned start of study drug.
- Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.
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 |
|---|---|---|
| INCAGN02390Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD. | Drug | INCAGN02390 |
Primary outcome
Number of treatment-emergent adverse events
Time frame: Up to 12 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
Time frame: Up to approximately 1 month
PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
10 secondary outcomes
Cmax of INCAGN02390
Time frame: Up to 12 months
Tmax of INCAGN02390
Time frame: Up to 12 months
Cmin of INCAGN02390
Time frame: Up to 12 months
AUC0-t of INCAGN02390
Time frame: Up to 12 months
Objective response rate
Time frame: Up to 12 months
Duration of response
Time frame: Up to 12 months
Disease control rate
Time frame: Up to 12 months
Progression-free survival
Time frame: Up to 12 months
Level of binding of INCAGN02390 to TIM-3
Time frame: Up to approximately 3 months
Immunogenicity of INCAGN02390
Time frame: Up to 12 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 15 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
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
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Nawel Bourayou, MD study director
Incyte Corporation
4 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 INCAGN02390 in people with Cervical Cancer and Gastric Cancer, run by Incyte Corporation at 4 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 5 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Number of treatment-emergent adverse events (time frame: Up to 12 months). 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 15 Nov 2021.