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A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor (PSCI# 21-039)

The purpose of the dose-escalation part is to evaluate GEN1046 in subjects with solid malignant tumors to determine the maximum tolerated dose (MTD) or maximum administered dose and/or the recommended phase 2 dose (RP2D). The purpose of the expansion part is the further evaluate the safety, tolerability, PK and antitumor activity of the selected dose(s) in select solid tumors.

The participants will be required to follow the trial doctor's instructions, have tests and checks done as part of the trial, inform the trial doctor of any changes in how they are feeling, be open and honest about their health history, inform the study team of all concomitant medications, and inform the trial doctor if you decide not to participate in the trial anymore.

Patrick Ma 717-531-5471

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Subject must be at least 18 years of age
Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 monoclonal antibody (mAb)
Subject must have tumor PD-L1 expression of tumor proportion score (TPS) >= 1%
Subject must have measurable disease per RECIST v1.1
Subject must have Eastern Cooperative Oncology Group (ECOG) PS <= 1

Exclusion Criteria:
Subject has documentation of known EGFR, ROS1 or ALK mutations or gene rearrangements
Subject has been exposed to prior treatment with docetaxel for NSCLC
Subject has been exposed to prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine or autologous cell immunotherapy
Subject has been exposed to treatment with an anti-cancer agent within 28 days prior to GEN1046 administration
Subject discontinued treatment due to disease progression within the first 6 weeks of a CPI-containing treatment
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Hershey, PA ,