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NCT04234113 · REGISTRY CONDITION SEARCH

Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2026-03-27

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Serious AEs (SAEs)

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outcome · POSTED

Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa

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outcome · POSTED

Number of Participants Who Died

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outcome · POSTED

Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)

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outcome · POSTED

Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ CD8+ T Cells on Day 6 of Cycle 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ CD8+ CD45RO+ CD45RA- T Cells on Day 6 of Cycle 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ CD4+ T Cells on Day 6 of Cycle 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ NKT Cells on Day 6 of Cycle 1

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outcome · POSTED

Overall Activation Levels of Ki-67+ Treg Cells on Day 6 of Cycle 1

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Clinical Benefit Rate

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Number of Participants With Anti-drug Antibodies at the End of Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion criteria: * Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * ECOG performance score 0-1. Patients with ECOG performance score 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion. * Estimated life expectancy of ≥3 months * Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy * At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy. * Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy * Adequate organ system function * Negative serum pregnancy test, if woman of child-bearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized). * Accessible tumor tissue available for fresh biopsy Exclusion criteria: * Untreated central nervous system metastases and/or leptomeningeal carcinomatosis * Known additional malignancy that is progressing and/or requires active treatment * Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar) * History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring chronic obstructive pulmonary disease or any chronic inflammatory disease (sarcoidosis etc.) * Has received a live vaccine within 30 days of planned start of study therapy * Absolute white blood cell count ≤2.0 ×10e9/L * Absolute neutrophil count ≤1.0 ×10e9/L * Platelet count ≤100×10e9/L * Pregnant or breastfeeding women * Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy * Specific co-morbidities * Parts B and B1: * Is hypersensitive to any of the ingredients of pembrolizumab drug product (KEYTRUDA®) * History of solid organ transplantation or hematopoietic stem cell transplantation
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.25 μg/kg
    type
    EXPERIMENTAL
  2. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.75 μg/kg
    type
    EXPERIMENTAL
  3. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 1.5 μg/kg
    type
    EXPERIMENTAL
  4. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 3 μg/kg
    type
    EXPERIMENTAL
  5. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 6 μg/kg
    type
    EXPERIMENTAL
  6. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 9 μg/kg
    type
    EXPERIMENTAL
  7. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 12 μg/kg
    type
    EXPERIMENTAL
  8. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 15 μg/kg
    type
    EXPERIMENTAL
  9. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 9 μg/kg
    type
    EXPERIMENTAL
  10. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle twice a day as 2 divided doses (50%:50%) with the second dose on each treatment day administered 8 hours (±15 min) after the first dose.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    label
    Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 12 μg/kg
    type
    EXPERIMENTAL
  11. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    2. Drug: Pembrolizumab
    label
    Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 1.5 μg/kg
    type
    EXPERIMENTAL
  12. description
    Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose. Pembrolizumab 200 mg was administered intravenously on day 1 of the 21-day treatment cycle.
    intervention Names
    1. Drug: Nanrilkefusp alfa
    2. Drug: Pembrolizumab
    label
    Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 3 μg/kg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.25 μg/kg
    2. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.75 μg/kg
    3. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 1.5 μg/kg
    4. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 12 μg/kg
    5. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 15 μg/kg
    6. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 3 μg/kg
    7. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 6 μg/kg
    8. Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 9 μg/kg
    9. Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 12 μg/kg
    10. Part A1 (nanrilkefusp alfa divided dosing, monotherapy), nanrilkefusp alfa 9 μg/kg
    11. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 1.5 μg/kg
    12. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 12 μg/kg
    description
    A fusion protein which consists of the N-terminal sushi domain of human IL-15 receptor α covalently coupled via a linker of 20 amino acids to human IL-15
    name
    Nanrilkefusp alfa
    other Names
    1. SOT101
    2. SO-C101
    3. RLI-15
    type
    DRUG
  2. arm Group Labels
    1. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 1.5 μg/kg
    2. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 12 μg/kg
    3. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 3 μg/kg
    4. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 6 μg/kg
    5. Part B (nanrilkefusp alfa combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg
    6. Part B1 (nanrilkefusp alfa divided dosing, combined with pembrolizumab), nanrilkefusp alfa 9 μg/kg
    description
    A humanized IgG4 monoclonal antibody with high specificity of binding to the PD-1 receptor
    name
    Pembrolizumab
    other Names
    1. KEYTRUDA®
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
115
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    * Grade (gr) 5 not related to disease progression or other causes * Gr ≥3 non-hematologic toxicity; exceptions: gr 3 nausea, vomiting or diarrhea controlled in 72 hours; gr 3 fatigue \<5 days; gr ≥3 correctable electrolyte abnormalities \<72 hours and no clinical complications; gr ≥3 amylase or lipase without clinical pancreatitis * Hy's law cases * Gr 3 AST or ALT or gr 3 bilirubinemia \>5 days * Hematologic DLTs: gr 4 neutropenia or thrombocytopenia \>7 days, febrile neutropenia, gr ≥3 thrombocytopenia with bleeding * Gr 4 immune-related AEs * Gr 3 or 4 non-infectious pneumonitis * Gr 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, not downgrading to gr ≤2 in 3 days despite maximal supportive care including systemic corticosteroids or to gr 1 or baseline in 14 days * Gr 2 pneumonitis not downgrading to gr 1 in 3 days * Gr 3 colitis * Part B and Part B1: Recurrent grade 2 pneumonitis
    measure
    Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    Through Cycle 1 (21 days)
  2. description
    Nanrilkefusp alfa related only
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Day 1 up to approximately 2 years and 2.5 months
  3. description
    Nanrilkefusp alfa related only
    measure
    Number of Participants With Serious AEs (SAEs)
    time Frame
    Day 1 up to approximately 2 years and 2.5 months
  4. description
    Nanrilkefusp alfa related only
    measure
    Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa
    time Frame
    Day 1 up to approximately 2 years and 2.5 months
  5. description
    Nanrilkefusp alfa-related deaths only
    measure
    Number of Participants Who Died
    time Frame
    Day 1 up to approximately 2 years and 2.5 months
  6. description
    The following laboratory parameters were assessed: * Coagulation: Prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, fibrinogen * Hematology: Hemoglobin, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, platelet count * Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, lipase * Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, white blood cell count, epithelial cells, bacteria * Thyroid function: TSH, free triiodothyronine (T3), free thyroxine (T4) * Cardiac function: Cardiac troponin T
    measure
    Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)
    time Frame
    Day 1 up to approximately 2 years and 2.5 months
secondary Outcomes
  1. description
    This outcome measure presents the overall nanrilkefusp apfa Cmax profile over Cycle 1 Day 1.
    measure
    Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1
    time Frame
    Cycle 1 Day 1
  2. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD8+ Cells (10\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ CD8+ T Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  3. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: * Ki-67+ Cells of CD8+ Cells (10\^9/L) = Ki-67+ Cells of CD8+ Cells (%CD45+) x 0.01 x WBC * CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (10\^9/L) = CD45RO+ CD45RA- (Memory) Cells of CD8+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01. Absolute count of CD45RO+ CD45RA- (Memory) Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ CD8+ CD45RO+ CD45RA- T Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  4. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD4+ Cells (10\^9/L) = Ki-67+ Cells of CD4+ Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ CD4+ T Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  5. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of CD3-CD56+ (NK) Cells (10\^9/L) = Ki-67+ Cells of CD3-CD56+ (NK) Cells (%CD45+) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ NK Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  6. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • CD3+CD56+ (NKT) Cells of CD45+ Live Cells (10\^9/L) = CD3+CD56+ (NKT) Cells of CD45+ Live Cells (%) x 0.01 x WBC Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of Live Cells multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ NKT Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  7. description
    The eCRF Hematology data (specifically white blood cell count (WBC)) for each timepoint will be used to derive the Cell counts in 10\^9/L. Once merged with the pharmacodynamic data by subject and timepoint, the following will be used as derivation: • Ki-67+ Cells of Treg Cells (10\^9/L) = Ki-67+ Treg Cells (%CD45+) x 0.01 x WBC" Absolute count of Ki-67+ Cells was calculated as percentage of those cells out of CD45+ multiplied by WBC and 0.01.
    measure
    Overall Activation Levels of Ki-67+ Treg Cells on Day 6 of Cycle 1
    time Frame
    Cycle 1 Day 6
  8. description
    Based on investigator review of radiographic images according to Response Evaluation Criteria In Solid Tumors for immune-based therapeutics (iRECIST). Objective response rate according to iRECIST was defined as the percentage of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI.
    measure
    Objective Response Rate
    time Frame
    Day 1 up to approximately 5 years 5 months
  9. description
    Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST for target lesions and assessed by CT/MRI.
    measure
    Duration of Response
    time Frame
    Day 1 up to approximately 5 years 5 months
  10. description
    Based on investigator review of radiographic images according to iRECIST. Clinical benefit rate according to iRECIST was defined as the percentage of patients with partial responses, complete responses, and stable disease according to iRECIST for target lesions and assessed by CT/MRI.
    measure
    Clinical Benefit Rate
    time Frame
    Day 1 up to approximately 5 years 5 months
  11. description
    Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.
    measure
    Progression-free Survival
    time Frame
    Day 1 up to approximately 5 years 5 months
  12. measure
    Number of Participants With Anti-drug Antibodies at the End of Treatment
    time Frame
    Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 5 years 5 months
Full study description
brief Summary
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
detailed Description
This study will assess the safety and tolerability of nanrilkefusp alfa administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary tract cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).
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    Preserved source evidence · Not medical advice