NCT04332653|CompletedPhase 1ResultsFDA Drug

NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

An Open-label Phase 1b/2a Study of NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors

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3 other identifiers

NIT-110MK-3475-A60KEYNOTE-A60

Study Type

interventional

Target

215

Locations

1 country

Sites

Timeline

RegisteredApr 2020

StartedJun 2020

CompletionJan 2025

Brief 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 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

215

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jun 2020

Longer than P75 for phase_1

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

March 31, 2020

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 9, 2026

Completed

Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

March 31, 2020

Results QC Date

December 1, 2025

Last Update Submit

February 13, 2026

Conditions

Any Advanced Solid Tumors Triple Negative Breast Cancer Non Small Cell Lung Cancer Small Cell Lung Cancer Microsatellite Stable Colorectal Cancer Pancreatic Cancer Ovarian Cancer

Keywords

NT-I7 (Efineptakin alfa)Solid TumorPembrolizumabNeoplasmsLungBreastPancreasColorectalNon-small Cell LungSmall Cell LungThoracic NeoplasmsInterleukin 7CarcinomaCancerProgrammed cell death protein (PD-1)Ovarian

Outcome Measures

Primary Outcomes (4)

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: 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.
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.
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.
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.
Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years)

Secondary Outcomes (7)

Biomarker Cohort: ORR
Up to 2 years
Phase 1b/2a: Duration of Objective Response (DOR)
Up to 2 years
Phase 1b/2a: Disease Control Rate (DCR)
Up to 2 years
Phase 1b/2a: Progression Free Survival (PFS)
Up to 2 years
Phase 1b/2a: Overall Survival (OS)
Up to 2 years
+2 more secondary outcomes

Study Arms (9)

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.