Advanced or Metastatic Solid TumorsPhase 1/2NCT04408599
A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing NC410 in people with Advanced or Metastatic Solid Tumors and Ovarian Cancer, run by NextCure, Inc. at 5 sites in United States.
Trial summary
This research study is studying a new drug, NC410, as a possible treatment for 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 or Metastatic Solid Tumors, Ovarian Cancer, Gastric Cancer
- What is being tested?
- NC410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Jun 2020to 6 Jul 2023
- 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
- Men and women aged 18 or older.
- Willingness to provide written informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- 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. Note: There is no limit to the number of prior treatment regimens.
- Presence of measurable disease based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
- After dose escalation, subject must be willing to undergo pretreatment and on-treatment tumor biopsies (core or excisional). Note: A baseline biopsy obtained for other purposes (i.e., not an NC410-01 study procedure) before signing consent may be utilized if the subject has not had any intervening systemic therapy from the time of the biopsy to the start of treatment with the medical monitor's approval.
- Female subjects of childbearing potential (defined as women who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum pregnancy test at screening. All female and male subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy or fathering children (with at least 99% certainty) from screening through 60 days after the last dose of study drug.
Who cannot join
- Inability to comprehend or unwilling to sign the Informed Consent Form.
- Screening laboratory values of:
- Absolute neutrophil count < 1.5 × 10^9/L
- Platelets < 100 × 10^9/L
- Hemoglobin < 9 g/dL or < 5.6 mmol/L
- Serum creatinine > 1.5 × institutional upper limit of normal (ULN)
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN
- Total bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no institutional ULN, then direct bilirubin must be < 40% of total bilirubin.
- International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN
- Activated partial thromboplastin time (aPTT) > 1.5 × ULN
- Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before the first administration of study drug.
- Receipt of anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
- ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation therapy. Subjects must also not require chronic use of corticosteroids and must not have had radiation pneumonitis because of a treatment. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease with medical monitor approval. Note: Bisphosphonates and denosumab are permitted medications.
- ≤ 28 days for prior immunotherapy or persistence of active cellular therapy (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be discussed with the medical monitor to determine eligibility).
- ≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for denosumab.
- ≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the medical monitor.
- ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long half-lives (e.g., > 5 days), enrollment before the fifth half-life requires medical monitor approval.
- 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. Note: Subjects with stable chronic conditions (≤ Grade 2) not expected to resolve (such as neuropathy and alopecia) are exceptions and may enroll. Note: Subjects with a history of any grade immune-related ocular AE (e.g., episcleritis, scleritis, uveitis) will be excluded.
- Receipt of a live vaccine within 30 days of planned start of study therapy. 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 (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Subjects who have not required systemic treatment in the past 2 years may be eligible with approval of the medical monitor. Note: Subjects with hyper/ hypothyroidism are eligible to participate. Note: Replacement and symptomatic therapies (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic immune suppressive therapy and are allowed.
- Known active CNS metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 28 days before the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases or CNS edema, and have not required steroids for at least 7 days before the first dose of study drug.
- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry apart from 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 subject has been disease-free for > 1 year, after treatment with curative intent.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- Active infection requiring systemic therapy.
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation. HBV-DNA and HCV-RNA must be undetectable. Subjects cannot be positive for HBV-DNA, HCV-RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody. Note: Subjects with no prior history of hepatitis B infection who have been vaccinated against hepatitis B and who have a positive antibody against hepatitis B surface antigen test as the only evidence of prior exposure may participate in the study.
- Known history of HIV (HIV 1 or HIV 2 antibodies).
- Known allergy or reaction to any component of study drug or formulation components.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 60 days after the last dose of study treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
NIH National Cancer Institute (NCI)
Bethesda, Maryland, 20892
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
UT MD Anderson Cancer Center
Houston, Texas, 77030
NYU Langone Health
New York, New York, 10016
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
- Being tested
- NC410
- Keywords
- Advanced Cancer, Metastatic Cancer, NC410, Solid Tumor, Immunotherapy, PK, Ovarian Cancer, Gastric Cancer, Colo-rectal Cancer
- Medical subject headings
- Ovarian Neoplasms, Stomach Neoplasms, Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC410Drug
NC410 is an experimental antibody drug that may make the immune response more active against cancer
| Study group | Role | What they receive |
|---|---|---|
| NC410 3mg | Experimental | 3mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 6mg | Experimental | 6mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 15mg | Experimental | 15mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 30mg | Experimental | 30mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 60mg | Experimental | 60mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 100mg | Experimental | 100mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
| NC410 200mg | Experimental | 200mg of NC410 for IV infusion administered in 14 day dosing cycles Receives: Drug: NC410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Number of Participants With Treatment-emergent Adverse Events
Measured: From enrollment through up to 90 days after end of treatment, an average of 1 year
Secondary outcomes (8)
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating objective response rate (ORR), defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Approximately 1 year
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
To assess antitumor activity/efficacy by evaluating duration of response (DoR), defined as the time from the first documented complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Modified Response Evaluation Criteria in Solid Tumors to the first documented progressive disease or death due to any cause, whichever occurs first. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: CompleteResponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
.
Measured: Approximately 1 year
Disease Control Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To assess antitumor activity/efficacy by evaluating disease control rate (DCR), defined as the proportion of participants in whom a documented complete response, partial response, or stable disease is observed as the best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 1 year
Maximum Plasma Concentration (Cmax) of NC410
To evaluate the Maximum Plasma Concentration (Cmax) of NC410
Measured: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC410 to the first occurrence of documented progressive disease or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), asa 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
.
Measured: Approximately 1 year
Overall Survival (OS) as Assessed by Time of Death
To evaluate overall survival (OS), defined as the time from the first dose of NC410 to death due to any cause.
Measured: Approximately 1 year
Area Under the Curve (AUC) of NC410
To evaluate the Area Under the Curve (AUC) of NC410.
Measured: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Half-life (t1/2) of NC410
To evaluate the half-life (t1/2) of NC410
Measured: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start10 Jun 2020
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Why it stopped: Upon completion of the Phase 1 portion of the NC410 monotherapy trial, NextCure focused efforts on a combination trial of NC410 in solid tumors.
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.
- Other trials for Advanced or Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Myint, MD, Study director, NextCure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408599
- Sponsor's protocol ID
- NC410-01
- Status last verified
- Jul 2024
- First submitted
- 19 May 2020
- Last updated
- 25 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Jul 2024. 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 NC410 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04408599
- Acronym / sponsor ID
- NC410-01
- Keywords
- Advanced Cancer, Metastatic Cancer, NC410, Solid Tumor, Immunotherapy, PK, Ovarian Cancer, Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Upon completion of the Phase 1 portion of the NC410 monotherapy trial, NextCure focused efforts on a combination trial of NC410 in solid tumors.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NextCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a new drug, NC410, as a possible treatment for advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| NC410 3mg | Experimental | Drug: NC4103mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 6mg | Experimental | Drug: NC4106mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 15mg | Experimental | Drug: NC41015mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 30mg | Experimental | Drug: NC41030mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 60mg | Experimental | Drug: NC41060mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 100mg | Experimental | Drug: NC410100mg of NC410 for IV infusion administered in 14 day dosing cycles |
| NC410 200mg | Experimental | Drug: NC410200mg of NC410 for IV infusion administered in 14 day dosing cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 18 or older.
- Willingness to provide written informed consent for the study.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- 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. Note: There is no limit to the number of prior treatment regimens.
Key exclusion criteria (29 listed)
- Inability to comprehend or unwilling to sign the Informed Consent Form.
- Screening laboratory values of:
- Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before the first administration of study drug.
- Receipt of anticancer medications or investigational drugs within the following 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. Note: Subjects with stable chronic conditions (≤ Grade 2) not expected to resolve (such as neuropathy and alopecia) are exceptions and may enroll. Note: Subjects with a history of any grade immune-related ocular AE (e.g., episcleritis, scleritis, uveitis) will be excluded.
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 |
|---|---|---|
| NC410NC410 is an experimental antibody drug that may make the immune response more active against cancer | Drug | NC410 100mg, NC410 15mg, NC410 200mg, NC410 30mg, NC410 3mg, NC410 60mg, NC410 6mg |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year
Number of Participants With Treatment-emergent Adverse Events
8 secondary outcomes
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Duration of Response Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
Time frame: Approximately 1 year
Disease Control Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Maximum Plasma Concentration (Cmax) of NC410
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and Modified Response Evaluation Criteria in Solid Tumors
Time frame: Approximately 1 year
Overall Survival (OS) as Assessed by Time of Death
Time frame: Approximately 1 year
Area Under the Curve (AUC) of NC410
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Half-life (t1/2) of NC410
Time frame: Days 1, 2, 3 and 8 of Cycles 1 and 5. Each cycle is 14 days in duration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
Han Myint, MD study director
NextCure, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NC410 in people with Advanced or Metastatic Solid Tumors and Ovarian Cancer, run by NextCure, Inc. at 5 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 8 inclusion and 29 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: stopped early, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 25 Jul 2024). 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-emergent Adverse Events as Assessed by CTCAE v5.0 (time frame: From enrollment through up to 90 days after end of treatment, an average of 1 year). 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 25 Jul 2024.