CompletedPhase 1/2

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

United States215 participantsStarted 2020-06-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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, 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). * 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 …

What they're measuring

Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs

Timeframe: Up to 2 years and 3 months

Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

Timeframe: Up to 21 days

Phase 2a (Arms I to Va): Objective Response Rate (ORR)

Timeframe: Up to 2 years

Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)

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

Trial details

NCT IDNCT04332653

SponsorNeoImmuneTech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-22

Results submitted2025-12-01

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