An Open-label Phase 1b/2a Study of NT-I7 (efineptakin alfa) in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Advanced Solid Tumors
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).
To determine the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 in combination with pembrolizumab in subjects with advanced solid tumors.
To assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in subjects with CPI treated R/R tumors (TNBC, NSCLC, SCLC), and CPI naïve R/R tumors (MSS-CRC and PC), based Overall Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
To further assess the anti-tumor activity of NT-I7 in combination with pembrolizumab in these patient populations based on Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS).
To evaluate immunogenicity of NT-I7 administered in combination with pembrolizumab in these patient populations.
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, 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 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.
Receiving any anti-cancer therapy (approved or investigational) with half-life > Has received prior radiotherapy within 2 weeks of start of study treatment.
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).
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