NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (KEYNOTE A60)

STATUS

Recruiting
End date

May 20, 2024
participants needed

238
sponsor

NeoImmuneTech

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Updated on 24 July 2022

See if I qualify

cancer

tyrosine

monoclonal antibodies

measurable disease

fluorouracil

kinase inhibitor

BRAF

oxaliplatin

capecitabine

immunohistochemistry

gemcitabine

pembrolizumab

ROS1

EGFR

irinotecan

programmed cell death 1 ligand 1

cancer chemotherapy

solid tumour

ovarian cancer

immunostimulant

cancer of the ovary

proto-oncogene tyrosine-protein kinase ros

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).

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).

Details

Condition	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
Treatment	Pembrolizumab, NT-I7
Clinical Study Identifier	NCT04332653
Sponsor	NeoImmuneTech
Last Modified on	24 July 2022

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Eligibility		Yes	No	Not Sure
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 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
Exclusion Criteria
	Pregnant, lactating or breastfeeding
	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
	Receiving chemotherapy or any anti-cancer therapy (approved or investigational) with half-life <1 week within 30 days or 5 half-lives
	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)

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NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (KEYNOTE A60)