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

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).
• •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).