High-risk Prostate CancerPhase 2NCT06765954
Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.
A Phase 2 study testing N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus) and M-CENK (Activated NK Cells) in people with High-risk Prostate Cancer, run by ImmunityBio, Inc..
Trial summary
This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy. Researchers will track how well the treatment works and how safe it is. The study will last about five years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-risk Prostate Cancer
- What is being tested?
- N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus) and M-CENK (Activated NK Cells)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Jun 2031
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior treatment for prostate cancer: Participants who have undergone any prior surgical, cryotherapy, or high-intensity focused ultrasound treatment for prostate cancer are excluded.
- Prior hormonal therapy: Prior orchiectomy or hormonal therapy (GnRH agonists, NSAA) is an exclusion criterion.
- Prior treatment with androgen receptor (AR) inhibitors: Prior treatment with first-generation (bicalutamide, flutamide, nilutamide, cyproterone acetate) or second-generation (enzalutamide, apalutamide, or darolutamide) AR inhibitors is an exclusion criterion.
- Organ transplantation: Receipt of any organ transplantation (excluding those not requiring immunosuppression, such as corneal or hair transplants) excludes participants from the study.
- Chronic systemic corticosteroid use: Chronic administration (>14 days) of systemic corticosteroids within 28 days of study treatment initiation excludes participants. However, minimal systemic absorption (inhaled steroids, nasal sprays, topical agents) is permitted.
- Active autoimmune disease: Active autoimmune diseases (Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjögren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease) exclude participants. However, a history of autoimmunity that did not require systemic immunosuppression and did not threaten vital organ function is permitted.
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- Use of medications affecting PSA: Use of medications known to alter PSA levels (5-alpha reductase inhibitors, phytoestrogens, saw palmetto) within 28 days before study treatment initiation excludes participants.
- Major surgery: Major surgery within 28 days of study treatment initiation excludes participants.
- Systemic therapy: Systemic therapy (including any investigational therapy) within 28 days of study treatment initiation is an exclusion criterion.
- Allergic reactions: A history of allergic reactions to compounds with similar chemical or biologic composition to the study drugs excludes participants.
- Clinically significant cardiovascular/cerebrovascular disease: This includes cerebral vascular accident/stroke, myocardial infarction, or unstable angina, congestive heart failure, or uncontrolled hypertension within specific timeframes before study enrollment.
- Serious intercurrent medical illness: Any serious intercurrent medical illness that could interfere with treatment participation.
- Active infections: Active HIV, hepatitis B (positive HBsAg), or hepatitis C infections exclude participation.
- Live attenuated vaccine administration: Administration of a live, attenuated vaccine within 3 weeks prior to study entry or anticipated during the study.
- Inability or unwillingness to comply: Participants assessed by the investigator as unable or unwilling to comply with the study requirements are excluded.
About this study
Official title: Open-Label, Phase 2 Clinical Trial of Pre-Radiation and Post-Radiation Immunotherapy With N-803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer
This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy. Researchers will track how well the treatment works and how safe it is. The study will last about five years.
Read the detailed description
This study (ResQ110B-PROS, IND 027158) is a Phase 2, open-label clinical trial designed to assess the safety and efficacy of a novel, multi-component treatment strategy for men with high-risk prostate cancer who are unsuitable for prostatectomy. The experimental treatment combines three investigational products with standard external beam radiation therapy (EBRT). The study is interventional, not observational.
The Investigational Products:
N-803 (nogapendekin alfa inbakicept): A soluble complex of an IL-15 variant bound to a human IL-15 receptor alpha subunit/human IgG1 Fc fusion protein. It acts as a growth and activation factor for NK cells and effector and memory T cells, aiming to stimulate the immune system's response to the cancer. Administered subcutaneously (SC).
ETBX-071 (hAd5 [E1-, E2b-, E3-]-PSA): A replication-defective human adenovirus serotype 5 (hAd5) vector modified to encode human prostate-specific antigen (PSA). This acts as a cancer vaccine, designed to generate an immune response targeting PSA-expressing prostate cancer cells. Administered subcutaneously (SC).
M-CENK (cytokine-induced memory-like NK cells): Autologous natural killer (NK) cells expanded and modified ex vivo using a cytokine cocktail (IL-12, IL-15, and IL-18) to enhance their cytotoxic activity and persistence. These cells are administered intravenously (IV).
Treatment Regimen:
The study employs a staged treatment approach:
Screening and Baseline Assessments: Participants undergo screening to confirm eligibility, including PSMA-PET scans, genomic testing, and PSA level assessment. Baseline assessments are collected before starting treatment.
Apheresis: Autologous peripheral blood mononuclear cells (MNCs) are collected from participants for the generation of M-CENK cells.
Pre-Radiation Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specified schedule over a 6-week period. A targeted biopsy is performed before radiation.
Radiation Therapy (EBRT): Participants undergo EBRT (either a standard 2-week course or an extended 9-week course, as determined by the investigator).
Post-Radiation Immunotherapy: Following radiation, participants receive N-803, ETBX-071, and M-CENK for four 6-week cycles. Androgen deprivation therapy (ADT) may be initiated 6 months after completing radiotherapy.
Follow-up: Participants are followed for up to 5 years after the end of treatment (EOT).
Endpoints:
Primary: Complete pathologic response (CPR) after pre-radiation immunotherapy and PSA30 response at EOT after post-radiation immunotherapy.
Secondary: Clinical pathologic response, time to recurrence interval (TTRI), and safety.
Exploratory: Quality of life (QoL), sexual function, immune responses (including changes in immune subsets and antigen-specific responses), tumor microenvironment (TME), and circulating tumor DNA (ctDNA).
Study Population and Duration:
The study plans to enroll up to 20 participants. The total study duration is up to 303 weeks, including treatment and 5 years of follow-up.
- Conditions
- High-risk Prostate Cancer
- Being tested
- N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus), M-CENK (Activated NK Cells), External Beam Radiation Therapy (EBRT), Androgen Deprivation Therapy (ADT)
- Keywords
- high-risk prostate cancer, Prostate Cancer, N-803, ETBX-071, M-CENK, Radiation Therapy/EBRT, Combination Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803 (IL-15 Superagonist)Drug
Administered subcutaneously (SC) both before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort.
ETBX-071 (PSA-based Oncolytic Virus)Drug
Administered subcutaneously (SC) before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort.
M-CENK (Activated NK Cells)Drug
Administered intravenously (IV) before and after radiation therapy, also with variations in the timing and dosing across different cohorts.
External Beam Radiation Therapy (EBRT)Radiation
This is a standard treatment administered to all participants. The specific dose and schedule (40 Gy in 5 fractions over 2 weeks or up to 9 weeks) are determined by the investigator based on clinical judgment.
Androgen Deprivation Therapy (ADT)Radiation
May be used in conjunction with the other therapies. The specific type and duration of ADT are at the investigator's discretion, and it may be initiated up to 6 months after the completion of radiotherapy. This treatment is not part of the experimental treatment regimen.
Post-radiation immunotherapyRadiation
The post-radiation immunotherapy phase in the ResQ110B-PROS study involves the continued administration of N-803, ETBX-071, and M-CENK, but with a specific schedule and after the completion of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care + Radiation therapy | Experimental | Combination of N-803, ETBX-071, and M-CENK, along with radiation therapy. Receives: Drug: N-803 (IL-15 Superagonist); Drug: ETBX-071 (PSA-based Oncolytic Virus); Drug: M-CENK (Activated NK Cells); Radiation: External Beam Radiation Therapy (EBRT); Radiation: Androgen Deprivation Therapy (ADT); Radiation: Post-radiation immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pathologic Response (CPR) after pre-radiation immunotherapy.
Complete Pathologic Response (CPR) after pre-radiation immunotherapy: Assesses the complete absence of cancer in tissue samples taken after the pre-radiation immunotherapy phase. This signifies a complete eradication of the cancer at that stage of the treatment process.
Measured: CPR: Assessed within approximately 6 weeks of study start.
PSA30 response at end-of-treatment (EOT) after post-radiation immunotherapy
Measures a ≥30% reduction in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. PSA is a common biomarker used to monitor prostate cancer treatment success. A decrease in PSA suggests successful treatment in reducing the cancer burden.
Measured: Assessed at EOT, which occurs roughly 30 to 39 weeks after the study begins.
Secondary outcomes (3)
Clinical Pathologic Response (after pre-radiation immunotherapy)
Clinical Pathologic Response (CPR) is an assessment of the extent of tumor reduction after treatment, combining clinical (imaging) and pathological (tissue examination) findings. In this study, CPR is evaluated both after pre-radiation and post-radiation immunotherapy. The specific criteria for determining CPR will vary depending on whether it's assessed by imaging or pathology.
Measured: Within approximately 6 weeks of the study start.
Time to Recurrence Interval (TTRI)
This measures the time elapsed between the completion of radiation therapy and the recurrence of the cancer. Longer TTRI indicates more durable treatment results.
Measured: Variable, ranging from the end of radiation therapy (around 2-9 weeks after pre-radiation immunotherapy, depending on individual schedules) to up to 5 years (260 weeks).
Safety (AEs and SAEs)
Safety will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the study, graded using the CTCAE v5.0 scale.
Measured: Continuous monitoring throughout the entire study duration (approximately 303 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Why it stopped: Study was redeveloped into a new protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- While the treatment involves multiple stages (pre-radiation immunotherapy, radiation, post-radiation immunotherapy), participants are assigned to one arm of the study and receive the complete treatment regimen within that arm. There's no crossover or other complex design element described; participants receive a consistent set of interventions according to their assigned group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Brown, Study chair, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765954
- Sponsor's protocol ID
- ResQ110B-PROS
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase 2 Clinical Trial of Pre-Radiation and Post-Radiation Immunotherapy With N-803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06765954
- Acronym / sponsor ID
- ResQ110B-PROS
- Conditions
- High-risk Prostate Cancer
- Keywords
- high-risk prostate cancer, Prostate Cancer, N-803, ETBX-071, M-CENK, Radiation Therapy/EBRT, Combination Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was redeveloped into a new protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Jan 2025 (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.
This study tests a new treatment for men with high-risk prostate cancer who can't have surgery. The treatment combines three experimental drugs and radiation therapy. Researchers will track how well the treatment works and how safe it is. The study will last about five years.
Detailed description
This study (ResQ110B-PROS, IND 027158) is a Phase 2, open-label clinical trial designed to assess the safety and efficacy of a novel, multi-component treatment strategy for men with high-risk prostate cancer who are unsuitable for prostatectomy. The experimental treatment combines three investigational products with standard external beam radiation therapy (EBRT). The study is interventional, not observational.
The Investigational Products:
N-803 (nogapendekin alfa inbakicept): A soluble complex of an IL-15 variant bound to a human IL-15 receptor alpha subunit/human IgG1 Fc fusion protein. It acts as a growth and activation factor for NK cells and effector and memory T cells, aiming to stimulate the immune system's response to the cancer. Administered subcutaneously (SC).
ETBX-071 (hAd5 [E1-, E2b-, E3-]-PSA): A replication-defective human adenovirus serotype 5 (hAd5) vector modified to encode human prostate-specific antigen (PSA). This acts as a cancer vaccine, designed to generate an immune response targeting PSA-expressing prostate cancer cells. Administered subcutaneously (SC).
M-CENK (cytokine-induced memory-like NK cells): Autologous natural killer (NK) cells expanded and modified ex vivo using a cytokine cocktail (IL-12, IL-15, and IL-18) to enhance their cytotoxic activity and persistence. These cells are administered intravenously (IV).
Treatment Regimen:
The study employs a staged treatment approach:
Screening and Baseline Assessments: Participants undergo screening to confirm eligibility, including PSMA-PET scans, genomic testing, and PSA level assessment. Baseline assessments are collected before starting treatment.
Apheresis: Autologous peripheral blood mononuclear cells (MNCs) are collected from participants for the generation of M-CENK cells.
Pre-Radiation Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specified schedule over a 6-week period. A targeted biopsy is performed before radiation.
Radiation Therapy (EBRT): Participants undergo EBRT (either a standard 2-week course or an extended 9-week course, as determined by the investigator).
Post-Radiation Immunotherapy: Following radiation, participants receive N-803, ETBX-071, and M-CENK for four 6-week cycles. Androgen deprivation therapy (ADT) may be initiated 6 months after completing radiotherapy.
Follow-up: Participants are followed for up to 5 years after the end of treatment (EOT).
Endpoints:
Primary: Complete pathologic response (CPR) after pre-radiation immunotherapy and PSA30 response at EOT after post-radiation immunotherapy.
Secondary: Clinical pathologic response, time to recurrence interval (TTRI), and safety.
Exploratory: Quality of life (QoL), sexual function, immune responses (including changes in immune subsets and antigen-specific responses), tumor microenvironment (TME), and circulating tumor DNA (ctDNA).
Study Population and Duration:
The study plans to enroll up to 20 participants. The total study duration is up to 303 weeks, including treatment and 5 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- While the treatment involves multiple stages (pre-radiation immunotherapy, radiation, post-radiation immunotherapy), participants are assigned to one arm of the study and receive the complete treatment regimen within that arm. There's no crossover or other complex design element described; participants receive a consistent set of interventions according to their assigned group.
| Arm | Type | Receives |
|---|---|---|
| Standard of care + Radiation therapy | Experimental | Drug: N-803 (IL-15 Superagonist), Drug: ETBX-071 (PSA-based Oncolytic Virus), Drug: M-CENK (Activated NK Cells), Radiation: External Beam Radiation Therapy (EBRT), Radiation: Androgen Deprivation Therapy (ADT), Radiation: Post-radiation immunotherapyCombination of N-803, ETBX-071, and M-CENK, along with radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Prior treatment for prostate cancer: Participants who have undergone any prior surgical, cryotherapy, or high-intensity focused ultrasound treatment for prostate cancer are excluded.
- Prior hormonal therapy: Prior orchiectomy or hormonal therapy (GnRH agonists, NSAA) is an exclusion criterion.
- Prior treatment with androgen receptor (AR) inhibitors: Prior treatment with first-generation (bicalutamide, flutamide, nilutamide, cyproterone acetate) or second-generation (enzalutamide, apalutamide, or darolutamide) AR inhibitors is an exclusion criterion.
- Organ transplantation: Receipt of any organ transplantation (excluding those not requiring immunosuppression, such as corneal or hair transplants) excludes participants from the study.
- Chronic systemic corticosteroid use: Chronic administration (>14 days) of systemic corticosteroids within 28 days of study treatment initiation excludes participants. However, minimal systemic absorption (inhaled steroids, nasal sprays, topical agents) is permitted.
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 |
|---|---|---|
| N-803 (IL-15 Superagonist)Administered subcutaneously (SC) both before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort. | Drug | Standard of care + Radiation therapy |
| ETBX-071 (PSA-based Oncolytic Virus)Administered subcutaneously (SC) before and after radiation therapy. The specific dosing schedule varies slightly depending on the cohort. | Drug | Standard of care + Radiation therapy |
| M-CENK (Activated NK Cells)Administered intravenously (IV) before and after radiation therapy, also with variations in the timing and dosing across different cohorts. | Drug | Standard of care + Radiation therapy |
| External Beam Radiation Therapy (EBRT)This is a standard treatment administered to all participants. The specific dose and schedule (40 Gy in 5 fractions over 2 weeks or up to 9 weeks) are determined by the investigator based on clinical judgment. | Radiation | Standard of care + Radiation therapy |
| Androgen Deprivation Therapy (ADT)May be used in conjunction with the other therapies. The specific type and duration of ADT are at the investigator's discretion, and it may be initiated up to 6 months after the completion of radiotherapy. This treatment is not part of the experimental treatment regimen. | Radiation | Standard of care + Radiation therapy |
| Post-radiation immunotherapyThe post-radiation immunotherapy phase in the ResQ110B-PROS study involves the continued administration of N-803, ETBX-071, and M-CENK, but with a specific schedule and after the completion of radiation therapy. | Radiation | Standard of care + Radiation therapy |
Primary outcome
Complete Pathologic Response (CPR) after pre-radiation immunotherapy.
Time frame: CPR: Assessed within approximately 6 weeks of study start.
Complete Pathologic Response (CPR) after pre-radiation immunotherapy: Assesses the complete absence of cancer in tissue samples taken after the pre-radiation immunotherapy phase. This signifies a complete eradication of the cancer at that stage of the treatment process.
PSA30 response at end-of-treatment (EOT) after post-radiation immunotherapy
Time frame: Assessed at EOT, which occurs roughly 30 to 39 weeks after the study begins.
Measures a ≥30% reduction in Prostate-Specific Antigen (PSA) levels from baseline to the end of treatment. PSA is a common biomarker used to monitor prostate cancer treatment success. A decrease in PSA suggests successful treatment in reducing the cancer burden.
3 secondary outcomes
Clinical Pathologic Response (after pre-radiation immunotherapy)
Time frame: Within approximately 6 weeks of the study start.
Time to Recurrence Interval (TTRI)
Time frame: Variable, ranging from the end of radiation therapy (around 2-9 weeks after pre-radiation immunotherapy, depending on individual schedules) to up to 5 years (260 weeks).
Safety (AEs and SAEs)
Time frame: Continuous monitoring throughout the entire study duration (approximately 303 weeks).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Bruce Brown study chair
ImmunityBio, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus) and M-CENK (Activated NK Cells) in people with High-risk Prostate Cancer, run by ImmunityBio, Inc..
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 0 inclusion and 15 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: withdrawn, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complete Pathologic Response (CPR) after pre-radiation immunotherapy. (time frame: CPR: Assessed within approximately 6 weeks of study start.). 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 5 May 2026.