Advanced or Metastatic Solid TumorsPhase 1/2NCT04875806
A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing NC762 in people with Advanced or Metastatic Solid Tumors and Ovarian Cancer, run by NextCure, Inc. at 8 sites in United States.
Trial summary
This research study is studying a new drug, NC762, 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, Non-small Cell Lung Cancer
- What is being tested?
- NC762
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Jun 2021to 30 Jan 2024
- 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.
- 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.
- Phase 1a Dose Escalation (optional), Phase 1b Safety Expansion, and Phase 2 (mandatory): Willingness to undergo pretreatment and on-treatment tumor biopsies (core or excisional).
- 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) and non-sterilized 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 90 days after the last dose of study drug. Females of child-bearing potential must have a negative serum pregnancy test at screening.
Who cannot join
- Inability to comprehend or unwilling to sign the ICF.
- Laboratory and medical history parameters not within the protocol-defined range.
- 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) and measured or calculated creatinine clearance < 50 mL/min for subjects with creatinine levels > 1.5 × institutional ULN.
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN. With the following exceptions: subjects with documented liver metastases AST and/or ALT ≤ 5 × ULN. Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 ×ULN.
- Total bilirubin ≥ 1.5 × ULN.
- International normalized ratio (INR) or prothrombin time (PT) > 1.5 × ULN; Activated partial thromboplastin time (aPTT) > 1.5 × ULN, except for subjects on anticoagulation.
- 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 7 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, hormonal therapy or radiation therapy. Subjects 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.
- ≤ 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 mAb used for anticancer therapy except for denosumab.
- ≤ 7 days for immune-suppressive-based treatment for any reason.
- ≤ 28 days or 5 half-lives, t½, (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 t½ requires medical monitor approval.
- ≤ 14 days for a COVID-19 vaccine. Note: For 2-dose vaccines, subjects must wait at least 14 days after administration of the 2nd dose of the vaccine prior to receiving the first dose of the study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy and radiation therapy) and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease that required systemic treatment in the past (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Known active CNS metastases and/or carcinomatous meningitis.
- Known concurrent malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Documented known activating or driver mutations (i.e. EGFR mutations/amplification, BRAF mutations, ALK alterations, etc.) which have not been previously treated with a standard of care targeted therapy.
- Subjects with screening QTc interval > 470 milliseconds (corrected by Fridericia) are excluded.
- Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti-infection treatment.
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured.
- 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 90 days after the last dose of study treatment.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
The University of Chicago Medicine and Biological Sciences
Chicago, Illinois, 60637
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Yale Cancer Center
New Haven, Connecticut, 06519
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 NC762 in Subjects With Advanced or Metastatic Solid Tumors
This research study is studying a new drug, NC762, as a possible treatment for advanced or metastatic solid tumors.
- Conditions
- Advanced or Metastatic Solid Tumors, Ovarian Cancer, Non-small Cell Lung Cancer, Breast Cancer
- Being tested
- NC762
- Keywords
- Advanced Cancer, Metastatic Cancer, NC762, Solid Tumor, Immunotherapy, PK, Ovarian Cancer, Lung Cancer, Breast Cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NC762Drug
NC762 is an experimental antibody drug that may make the immune response more active against cancer
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg/kg NC762 | Experimental | Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC762 |
| 1.5mg/kg NC762 | Experimental | Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC762 |
| 5mg/kg NC762 | Experimental | Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC762 |
| 10mg/kg NC762 | Experimental | Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC762 |
| 20mg/kg NC762 | Experimental | Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). Receives: Drug: NC762 |
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
Frequency, duration, and severity of treatment-emergent adverse events (AEs)
Measured: From enrollment through up to 90 days after end of treatment, an average of 1 year
Secondary outcomes (8)
Objective Response Rate (ORR) as Assessed by 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 (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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 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: Complete Response (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 (DCR) as Assessed by 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
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To evaluate progression-free survival (PFS), defined as the time from the first dose of NC762 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), as a 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)
To evaluate overall survival (OS), defined as the time from the first dose of NC762 to death due to any cause.
Measured: Approximately 1 year
Maximum Serum Concentration (Cmax) of NC762
To evaluate the Maximum Serum Concentration (Cmax) of NC762
Measured: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Area Under the Curve (AUC) of NC762
To evaluate the Area Under the Curve (AUC) of NC762
Measured: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Half-life (T1/2) of NC762
To evaluate the Half-life (T1/2) of NC762
Measured: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start30 Jun 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: Due to the limited activity in Phase 1, NextCure decided to discontinue development of the anti-B7-H4 antibody monotherapy trial (NC762-01) to move forward with a prioritized B7-H4 ADC program.
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
- Model description
- Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC762 at the RP2D utilizing a Simon 2-stage design.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04875806
- Sponsor's protocol ID
- NC762-01
- Status last verified
- Apr 2025
- First submitted
- 3 May 2021
- Last updated
- 22 Apr 2025
- 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 22 Apr 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 NC762 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04875806
- Acronym / sponsor ID
- NC762-01
- Conditions
- Advanced or Metastatic Solid Tumors, Ovarian Cancer, Non-small Cell Lung Cancer, Breast Cancer
- Keywords
- Advanced Cancer, Metastatic Cancer, NC762, Solid Tumor, Immunotherapy, PK, Ovarian Cancer, Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the limited activity in Phase 1, NextCure decided to discontinue development of the anti-B7-H4 antibody monotherapy trial (NC762-01) to move forward with a prioritized B7-H4 ADC program.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NextCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 22 Apr 2025
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, NC762, 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
- 5
- Model description
- Phase 1 will utilize a 3 + 3 design to explore escalating dose levels. Phase 2 Dose Expansion will further evaluate the safety, tolerability, preliminary efficacy, and PK/PD activity of NC762 at the RP2D utilizing a Simon 2-stage design.
| Arm | Type | Receives |
|---|---|---|
| 0.5mg/kg NC762 | Experimental | Drug: NC762Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| 1.5mg/kg NC762 | Experimental | Drug: NC762Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| 5mg/kg NC762 | Experimental | Drug: NC762Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| 10mg/kg NC762 | Experimental | Drug: NC762Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
| 20mg/kg NC762 | Experimental | Drug: NC762Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first). |
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.
- 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 (31 listed)
- Inability to comprehend or unwilling to sign the ICF.
- Laboratory and medical history parameters not within the protocol-defined range.
- 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 7 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 radiation therapy) and/or complications from prior surgical intervention before starting therapy.
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 |
|---|---|---|
| NC762NC762 is an experimental antibody drug that may make the immune response more active against cancer | Drug | 0.5mg/kg NC762, 1.5mg/kg NC762, 10mg/kg NC762, 20mg/kg NC762, 5mg/kg NC762 |
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
Frequency, duration, and severity of treatment-emergent adverse events (AEs)
8 secondary outcomes
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 1 year
Overall Survival (OS)
Time frame: Approximately 1 year
Maximum Serum Concentration (Cmax) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Area Under the Curve (AUC) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Half-life (T1/2) of NC762
Time frame: Days 1, 2, 3, and 8 of Cycles 1 and 5. Each cycle is 14 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Han Myint, MD study director
NextCure, Inc.
8 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 NC762 in people with Advanced or Metastatic Solid Tumors and Ovarian Cancer, run by NextCure, Inc. at 8 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 31 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 22 Apr 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. 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 22 Apr 2025). 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 22 Apr 2025.