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

Part of paid clinical trials in Tampa, Florida.

Sponsor
NeoImmuneTech
Study ID
NCT04332653
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NT-I7 — DRUG
    Administered by intramuscular (IM) injection
  • pembrolizumab (KEYTRUDA®) — DRUG
    Administered by intravenous (IV) injection

Study Details

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).

Key Dates

Start date
Jun 10, 2020
Status verified
Feb 2026
Primary completion
Nov 22, 2024
Completion
Jan 13, 2025

Study Design

Enrollment
215 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: NT-I7 Dose Escalation
    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.
  • Experimental: Phase 2a: CPI Treated Triple Negative Breast Cancer
    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.
  • Experimental: Phase 2a: CPI Treated Non-small Cell Lung Cancer
    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.
  • Experimental: Phase 2a: CPI Treated Small Cell Lung Cancer
    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.
  • Experimental: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer
    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.
  • Experimental: Phase 2a: CPI Naïve Pancreatic Cancer
    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.
  • Experimental: Phase 2a: CPI Naïve Microsatellite Stable Colorectal Cancer, Expansion Cohort
    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.
  • Experimental: Phase 2a: CPI Naïve Pancreatic Cancer, Expansion Cohort
    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.
  • Experimental: Biomarker Cohort: CPI Naïve Ovarian Cancer
    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.

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 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Moffit Cancer CenterTampaFlorida33612-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Duke University Medical CenterDurhamNorth Carolina27710-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research InstituteNashvilleTennessee37211-
Mary Crowley Cancer ResearchDallasTexas75230-
MD Anderson Cancer CenterHoustonTexas77030-

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By research site
Moffit Cancer Center· Tampa, FLBarbara Ann Karmanos Cancer Institute· Detroit, MIWashington University School of Medicine in St. Louis· St Louis, MODuke University Medical Center· Durham, NCFox Chase Cancer Center· Philadelphia, PASarah Cannon Research Institute· Nashville, TN

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