Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy 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.
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