Description:
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 tumors.
Title
- Brief Title: NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
NIT-110 (PNA60)
- NCT ID:
NCT04332653
Conditions
- Any Advanced Solid Tumors
- Triple Negative Breast Cancer
- Non Small Cell Lung Cancer
- Small Cell Lung Cancer
- Microsatellite Stable Colorectal Cancer
- Pancreatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
NT-I7 | Efineptakin alfa, rhIL-7-hyFc | Phase 1b: NT-I7 Dose Escalation |
Pembrolizumab | | Phase 1b: NT-I7 Dose Escalation |
Purpose
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 tumors.
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).
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)
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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. | |
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. | |
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. | |
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. | |
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. | |
Eligibility Criteria
Inclusion Criteria:
(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 and Arms I, IV, and V of the Phase 2a 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).
- Meet the requirements for the intended stages and arms (disease specific inclusion
criteria), as following:
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: 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: 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.
Exclusion Criteria:
- Pregnant, lactating or breastfeeding.
- Receiving any investigational therapy or any approved therapy for investigational use
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1b: Safety and Tolerability of NT-I7 in Combination With Pembrolizumab to Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Incidence, nature and severity of Adverse Events (AEs) graded according to NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Incidence and nature of Dose-Limiting Toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Duration of Objective Response (DOR) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Disease Control Rate (DCR) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Number of Participants Who Experience an Increase in Anti-Drug Antibodies (ADAs) to NT-I7 |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | NeoImmuneTech |
Trial 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)
Last Updated
February 15, 2021