Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001)

Exclusion Criteria

• •Prior treatment with anti-CD70 directed therapy
• •Prior therapy with an antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor payload
• •Prior allogeneic hematopoietic stem cell transplant (HSCT). Participants with prior autologous HSCT must have completed the procedure at least 100 days prior to the first dose of study drug.
• •Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of RCC should have a magnetic resonance imaging (MRI) of the brain at screening.
• •Primary central nervous system (CNS) tumor or known CNS involvement.
• •Has been exposed to any of the following prior therapies within the specified timeframes:
• •* Received prior investigational CD70-targeting therapy, eg, CD70-directed chimeric antigen receptor T-cell (CAR-T) therapy, anti-CD70 monoclonal antibody (mAb), CD3 x CD70 bispecific monoclonal antibody (bsAb), or CD70 antibody-drug conjugate.
• •* Autologous stem cell transplant within 60 days prior to the first dose of GEN1160.
• •* Allogeneic stem cell transplant within 90 days prior to the first dose of GEN1160.
• •* Chemotherapy within 2 weeks or major surgery within 4 weeks of the first dose of GEN1160.
• •* Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN1160.
• •* Treatment with an investigational drug within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of GEN1160 or currently receiving any other investigational agents.
• •* Prior treatment with live, attenuated vaccines within 30 days prior to the first dose of GEN1160. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Experimental and/or nonauthorized coronavirus disease (SARS-CoV-2) vaccinations are not allowed.
• •* Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at doses \> 25 milligrams (mg) daily or its equivalent within 14 days prior to the first dose of GEN1160.
• •History of symptomatic autoimmune disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \[eg, Wegener's granulomatosis\]).
• •Has clinically significant cardiac disease, including:
• •* Myocardial infarction within 6 months prior to the first dose of GEN1160, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III or IV), cardiac arrhythmia (Common Terminology Criteria for Adverse Events \[CTCAE\] Version 5.0 Grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities.
• •* Screening 12-lead ECG showing a baseline QT interval as corrected by QTcF \> 480 milliseconds (msec).
• •* Echocardiogram (ECHO) or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \< 45%.
• •Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower. Note, participants with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the trial.
• •Active graft versus host disease (GVHD) requiring immune suppression regardless of grade.