Any Advanced Solid TumorsPhase 1/2NCT04332653
NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
A Phase 1/2 study testing NT-I7 and pembrolizumab (KEYTRUDA®) in people with Any Advanced Solid Tumors and Triple Negative Breast Cancer, run by NeoImmuneTech at 8 sites in United States.
Trial summary
The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: Safety and tolerability of NT-I7 in combination with pembrolizumab Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this study is to assess the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer
- What is being tested?
- NT-I7 and pembrolizumab (KEYTRUDA®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jun 2020to 13 Jan 2025
- 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
- (Participants must meet all the following to be eligible)
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumors.
- Have measurable disease per RECIST v1.1.
- Participants enrolling in the Phase 1b, Arms I, IV, IVa, V, and Va of the Phase 2a, and the Biomarker Cohort OC must have biopsiable disease.
- Female participants who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female participants of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7).
- Non-sterile male participants who are sexually active with female partners of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use highly effective method(s) of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7).
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- Meet the requirements for the intended stages and arms (disease specific inclusion criteria), as follows:
- Applicable to the Dose escalation phase (Phase 1b) only: (Biopsy Arm)
- Relapsed/refractory advanced solid tumors.
- Applicable to the Dose expansion phase (Phase 2a) only:
- Anti-PD-1/anti-PD-L1 refractory criteria for CPI-treated TNBC, NSCLC, and SCLC
- Has received at least 2 doses of an approved anti-PD-1/anti-PD-L1 monoclonal antibody (mAb).
- Has demonstrated disease progression after anti-PD-1/anti-PD-L1.
- Specific to Arm I: CPI-treated R/R TNBC (Biopsy Arm)
- Histopathologic or cytologic documented TNBC.
- Received one or more prior therapies for TNBC in the advanced or metastatic setting, and prior treatment (for advanced, metastatic or (neo) adjuvant).
- Specific to Arm II: CPI-treated R/R NSCLC
- Had prior treatment with CPI. Participants with estimated glomerular filtration rate (EGFR), BRAF, or c-ros oncogene 1(ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations are required to have received prior therapy with the appropriate tyrosine kinase inhibitor (TKI).
- Specific to Arm III: CPI-treated R/R SCLC
- Recurrent extensive-stage SCLC; Received prior CPI therapy.
- Specific to Arm IV and IVa: CPI-naïve R/R MSS-CRC (Biopsy Arm)
- MSS-CRC (categorized as MSS by immunohistochemistry(IHC) or polymerase chain reaction (PCR).
- Previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan; participants treated with CPI are not eligible.
- Specific to Arm V and Va: CPI-naïve R/R Pancreatic Cancer (Biopsy Arm)
- Have documented radiographic progression to or documented in tolerance of first line systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine); participants treated previously with CPI are not eligible.
- Specific to Biomarker Cohort: CPI-naïve R/R Ovarian Cancer
- Up to 5 prior lines of treatment, including platinum-based treatment(s); participants treated previously with CPIs are not eligible.
- Willing to provide pre- and on-treatment tumor biopsies.
Who cannot join
- Pregnant, lactating or breastfeeding.
- Receiving chemotherapy or any anti-cancer therapy (approved or investigational) with half-life <1 week within 30 days or 5 half-lives.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if stable.
- Participants who have received treatment with systemic immunosuppressive medications.
- Has a history of non-infectious pneumonitis that required steroids or current pneumonitis.
- Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) and was discontinued from that treatment due to a Grade 3 or higher Immune related adverse event (irAE).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37211
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Moffit Cancer Center
Tampa, Florida, 33612
About this study
Official title: An Open-label Phase 1b/2a Study of NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors
The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors:
- Safety and tolerability of NT-I7 in combination with pembrolizumab
- Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D)
The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors.
The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).
Read the detailed description
This is a multicenter, open-label Phase 1b/2a study of NT-I7 in combination with pembrolizumab. The study consists of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a) and a Biomarker Cohort.
The Phase 1b is designed to assess the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7.
The main purpose of Phase 2a of this study is to assess the preliminary antitumor activity of NT-I7 in combination with pembrolizumab in participants with relapsed/refractory
- checkpoint inhibitor (CPI)-treated Triple Negative Breast Cancer (TNBC), Non-small Cell Lung Cancer (NSCLC), and Small Cell Lung Cancer (SCLC)
- checkpoint inhibitor (CPI)-naïve Microsatellite Stable Colorectal Cancer (MSS-CRC), and Pancreatic Cancer (PC) The Biomarker Cohort is designed to assess the correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits of NT-I7 in combination with pembrolizumab in participants with CPI naïve R/R Ovarian Cancer (OC).
- Conditions
- Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer
- Being tested
- NT-I7, pembrolizumab (KEYTRUDA®)
- Keywords
- NT-I7 (Efineptakin alfa), Solid Tumor, Pembrolizumab, Neoplasms, Lung, Breast, Pancreas, Colorectal, Non-small Cell Lung, Small Cell Lung, Thoracic Neoplasms, Interleukin 7, Carcinoma, Cancer, Programmed cell death protein (PD-1), Ovarian
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Pancreatic Neoplasms, Ovarian Neoplasms, Neoplasms, Thoracic Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-I7Drug
Also called Efineptakin alfa, rhIL-7-hyFc
Administered by intramuscular (IM) injection
pembrolizumab (KEYTRUDA®)Drug
Also called KEYTRUDA®
Administered by intravenous (IV) injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: NT-I7 Dose Escalation | Experimental | NT-I7 will be administered on Day 1 of alternate 21 day cycles (Cycle 1, 3, 5 etc.). Dosage will increase until the maximum tolerated dose (MTD) and/or the recommended phase 2 (RP2D) dose is reached.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Treated Triple Negative Breast Cancer | Experimental | Participants with checkpoint inhibitor (CPI) treated relapsed or refractory triple negative breast cancer (TNBC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Treated Non-small Cell Lung Cancer | Experimental | Participants with checkpoint inhibitor (CPI) treated relapsed or refractory non-small cell lung cancer (NSCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Treated Small Cell Lung Cancer | Experimental | Participants with checkpoint inhibitor (CPI) treated relapsed or refractory small cell lung cancer (SCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer | Experimental | Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Naïve Pancreatic Cancer | Experimental | Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort | Experimental | Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive 1200 µg/kg of NT-I7 and and a fixed dose of 200 mg of pemprolizumab.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort | Experimental | Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC).Participants will receive 1200 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
| Biomarker Cohort: CPI Naïve Ovarian Cancer | Experimental | Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory ovarian cancer (OC). Participants will receive a starting dose of 960 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab.
Pembrolizumab will be administered on Day 1 of every 21 day cycle. Receives: Drug: NT-I7; Drug: pembrolizumab (KEYTRUDA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes:
- Death;
- A life-threatening AE;
- An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Up to 2 years and 3 months
Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
A DLT was defined as any AE occurring within the first 21 days that was considered to be related to the trial treatments (NT-I7 and/or pembrolizumab) per the investigator, and that met at least one of the non-hematologic or hematologic criteria:
- Grade 4 non-hematologic toxicity
- Grade ≥ 3 diarrhea, nausea and vomiting
- Grade ≥ 3 rash for ≥ 5 days
- Grade 4 neutropenia for ≥ 5 days
- Febrile neutropenia Grade 3 or Grade 4
- Other Grade 4 hematologic toxicity for ≥7 days, except thrombocytopenia
- Any non-hematologic AE ≥ Grade 3 in severity
- Any Grade 3 or Grade 4 non-hematologic laboratory value if medical intervention was required, led to hospitalization, persisted for > 1 week, resulted in potential drug-induced liver injury
- Other Grade ≥ 3 clinical laboratory abnormalities not reversible to ≤ Grade 1 within 72 hours
- Prolonged delay in initiating Cycle 2
- Any treatment-related toxicity that caused treatment discontinuation in Cycle 1
- Grade 5 toxicity.
Measured: Up to 21 days
Phase 2a (Arms I to Va): Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had at least one confirmed partial response (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) and immune RECIST (iRECIST) as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 2 years
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
CD8 positivity TILs in tumor biopsy samples were identified using a validated immunohistochemistry (IHC) assay and certified by a pathologist. The percentage of area occupied by TILs was evaluated in the stroma area, tumor area and tumor - relevant tissue area both pre- and post-treatment.
Measured: Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years)
Secondary outcomes (7)
Biomarker Cohort: ORR
ORR was defined as the percentage of participants who had at least one confirmed PR or CR, per RECIST v1.1 and iRECIST as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 2 years
Phase 1b/2a: Duration of Objective Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
Measured: Up to 2 years
Phase 1b/2a: Disease Control Rate (DCR)
DCR was defined as the proportion of participants with a best overall response of CR, PR, stable disease (SD) per RECIST 1.1 and iRECIST as determined by the investigator..
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) at least a 20% increase in the sum of the diameters of target lesions), taking as reference the smallest sum diameters while on study.
Measured: Up to 2 years
Phase 1b/2a: Progression Free Survival (PFS)
PFS was defined as the time from the first trial treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first per RECIST 1.1 and iRECIST as determined by the investigator.
PD was defined as at least a 20% increase in the sum of the diameters of target lesions, using the smallest sum observed on study as reference, with an absolute increase of at least 5 mm, or the appearance of new lesions, or unequivocal progression of non-target lesions, per RECIST 1.1.
Measured: Up to 2 years
Phase 1b/2a: Overall Survival (OS)
OS was defined as the time from first trial treatment (Cycle 1, Day 1) to death from any cause.
Measured: Up to 2 years
Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7
Immunogenicity to NT-I7 was measured using a risk-based, tiered testing approach. This included screening and confirmatory assays for binding ADAs, epitope-specific assays to characterize ADA reactivity to whole NT-I7 vs IL-7 domain, and a cell-based neutralizing ADA assay for IL7 bioactivity. Participants' samples were obtained at baseline and over the course of treatment (to evaluate the prevalence and incidence of treatment-emergent/boosted ADA).
Not detected or detected but not confirmed ADA was defined as negative. Detected and confirmed ADA was defined as positive.
Measured: Up to 2 years
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes:
Death; A life-threatening AE; An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; A congenital anomaly/birth defect; Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: Up to 2 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start10 Jun 2020
- Primary completion22 Nov 2024
- Study completion13 Jan 2025
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 Any Advanced 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoImmuneTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp and Dohme LLC, Rahway, NJ, USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332653
- Sponsor's protocol ID
- NIT-110
- Other IDs
- MK-3475-A60, KEYNOTE-A60
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2020
- Last updated
- 9 Mar 2026
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1b/2a Study of NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04332653
- Acronym / sponsor ID
- NIT-110
- Conditions
- Any Advanced Solid Tumors, Triple Negative Breast Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Microsatellite Stable Colorectal Cancer, Pancreatic Cancer
- Keywords
- NT-I7 (Efineptakin alfa), Solid Tumor, Pembrolizumab, Neoplasms, Lung, Breast, Pancreas, Colorectal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- NeoImmuneTechIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp and Dohme LLC, Rahway, NJ, USA
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors:
- Safety and tolerability of NT-I7 in combination with pembrolizumab
- Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D)
The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors.
The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).
Detailed description
This is a multicenter, open-label Phase 1b/2a study of NT-I7 in combination with pembrolizumab. The study consists of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a) and a Biomarker Cohort.
The Phase 1b is designed to assess the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7.
The main purpose of Phase 2a of this study is to assess the preliminary antitumor activity of NT-I7 in combination with pembrolizumab in participants with relapsed/refractory
- checkpoint inhibitor (CPI)-treated Triple Negative Breast Cancer (TNBC), Non-small Cell Lung Cancer (NSCLC), and Small Cell Lung Cancer (SCLC)
- checkpoint inhibitor (CPI)-naïve Microsatellite Stable Colorectal Cancer (MSS-CRC), and Pancreatic Cancer (PC) The Biomarker Cohort is designed to assess the correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits of NT-I7 in combination with pembrolizumab in participants with CPI naïve R/R Ovarian Cancer (OC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: NT-I7 Dose Escalation | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)NT-I7 will be administered on Day 1 of alternate 21 day cycles (Cycle 1, 3, 5 etc.). Dosage will increase until the maximum tolerated dose (MTD) and/or the recommended phase 2 (RP2D) dose is reached. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Treated Triple Negative Breast Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) treated relapsed or refractory triple negative breast cancer (TNBC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Treated Non-small Cell Lung Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) treated relapsed or refractory non-small cell lung cancer (NSCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Treated Small Cell Lung Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) treated relapsed or refractory small cell lung cancer (SCLC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Naïve Pancreatic Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC). Participants will receive the recommended phase 2 dose (RP2D) identified during Phase 1b. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory microsatellite stable colorectal cancer (MSS-CRC). Participants will receive 1200 µg/kg of NT-I7 and and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory pancreatic cancer (PC).Participants will receive 1200 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
| Biomarker Cohort: CPI Naïve Ovarian Cancer | Experimental | Drug: NT-I7, Drug: pembrolizumab (KEYTRUDA®)Participants with checkpoint inhibitor (CPI) naïve relapsed or refractory ovarian cancer (OC). Participants will receive a starting dose of 960 µg/kg of NT-I7 and a fixed dose of 200 mg of pemprolizumab. Pembrolizumab will be administered on Day 1 of every 21 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- (Participants must meet all the following to be eligible)
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumors.
- Have measurable disease per RECIST v1.1.
- Participants enrolling in the Phase 1b, Arms I, IV, IVa, V, and Va of the Phase 2a, and the Biomarker Cohort OC must have biopsiable disease.
- Female participants who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female participants of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 120 days after the last dose of study treatment (pembrolizumab and/or NT-I7).
Key exclusion criteria (7 listed)
- Pregnant, lactating or breastfeeding.
- Receiving chemotherapy or any anti-cancer therapy (approved or investigational) with half-life <1 week within 30 days or 5 half-lives.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate if stable.
- Participants who have received treatment with systemic immunosuppressive medications.
- Has a history of non-infectious pneumonitis that required steroids or current pneumonitis.
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 |
|---|---|---|
| NT-I7Also: Efineptakin alfa, rhIL-7-hyFcAdministered by intramuscular (IM) injection | Drug | Biomarker Cohort: CPI Naïve Ovarian Cancer, Phase 1b: NT-I7 Dose Escalation, Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort, Phase 2a: CPI Naïve Pancreatic Cancer, Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort, Phase 2a: CPI Treated Non-small Cell Lung Cancer, Phase 2a: CPI Treated Small Cell Lung Cancer, Phase 2a: CPI Treated Triple Negative Breast Cancer |
| pembrolizumab (KEYTRUDA®)Also: KEYTRUDA®Administered by intravenous (IV) injection | Drug | Biomarker Cohort: CPI Naïve Ovarian Cancer, Phase 1b: NT-I7 Dose Escalation, Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort, Phase 2a: CPI Naïve Pancreatic Cancer, Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort, Phase 2a: CPI Treated Non-small Cell Lung Cancer, Phase 2a: CPI Treated Small Cell Lung Cancer, Phase 2a: CPI Treated Triple Negative Breast Cancer |
Primary outcome
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Time frame: Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: 1. Death; 2. A life-threatening AE; 3. An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; 4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; 5. A congenital anomaly/birth defect; 6. Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days
A DLT was defined as any AE occurring within the first 21 days that was considered to be related to the trial treatments (NT-I7 and/or pembrolizumab) per the investigator, and that met at least one of the non-hematologic or hematologic criteria: * Grade 4 non-hematologic toxicity * Grade ≥ 3 diarrhea, nausea and vomiting * Grade ≥ 3 rash for ≥ 5 days * Grade 4 neutropenia for ≥ 5 days * Febrile neutropenia Grade 3 or Grade 4 * Other Grade 4 hematologic toxicity for ≥7 days, except thrombocytopenia * Any non-hematologic AE ≥ Grade 3 in severity * Any Grade 3 or Grade 4 non-hematologic laboratory value if medical intervention was required, led to hospitalization, persisted for > 1 week, resulted in potential drug-induced liver injury * Other Grade ≥ 3 clinical laboratory abnormalities not reversible to ≤ Grade 1 within 72 hours * Prolonged delay in initiating Cycle 2 * Any treatment-related toxicity that caused treatment discontinuation in Cycle 1 * Grade 5 toxicity.
Phase 2a (Arms I to Va): Objective Response Rate (ORR)
Time frame: Up to 2 years
ORR was defined as the percentage of participants who had at least one confirmed partial response (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) and immune RECIST (iRECIST) as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm (<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Time frame: Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years)
CD8 positivity TILs in tumor biopsy samples were identified using a validated immunohistochemistry (IHC) assay and certified by a pathologist. The percentage of area occupied by TILs was evaluated in the stroma area, tumor area and tumor - relevant tissue area both pre- and post-treatment.
7 secondary outcomes
Biomarker Cohort: ORR
Time frame: Up to 2 years
Phase 1b/2a: Duration of Objective Response (DOR)
Time frame: Up to 2 years
Phase 1b/2a: Disease Control Rate (DCR)
Time frame: Up to 2 years
Phase 1b/2a: Progression Free Survival (PFS)
Time frame: Up to 2 years
Phase 1b/2a: Overall Survival (OS)
Time frame: Up to 2 years
Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7
Time frame: Up to 2 years
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Time frame: Up to 2 years and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 NT-I7 and pembrolizumab (KEYTRUDA®) in people with Any Advanced Solid Tumors and Triple Negative Breast Cancer, run by NeoImmuneTech 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 28 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. 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 9 Feb 2026). 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?
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs (time frame: Up to 2 years and 3 months). The study lists 4 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 9 Mar 2026.