a first-in-human trial of safety and efficacy of gen1078 in participants with solid tumors

Conditions: Malignant Solid Tumor

Summary: the purpose of this trial is to measure the following in participants with solid cancers who receive gen1078. * the side effects seen with gen1078 * what the body does with gen1078 once it is administered * what gen1078 does to the body once it is administered * how well gen1078 works against advanced solid tumors trial details include: * the estimated trial duration is 8 months for an individual participant (the trial duration may vary for each participant). * the treatment duration will be an estimated 3-month treatment period (the duration of treatment may vary for each participant). * the visit frequency will be daily or visits every few days for the first few months. all participants will receive active drug; no one will be given placebo.


Eligibility criteria:
key inclusion criteria: * must have at least 1 measurable lesion per recist v1.1 assessed by the investigator. * must have an eastern cooperative oncology group performance status (ecog ps) score of 0 to 1. dose escalation only * participant must have histologically or cytologically confirmed solid tumor(s) for which there is no further available standard therapy likely to confer clinical benefit (or participant is not a candidate or has previously refused such earlier available therapy), and for whom, in the opinion of the investigator, experimental therapy with gen1078 may be beneficial. * must have either recurrence after, or progression on available relevant standard of care (soc) anticancer therapies; or are deemed intolerant to or ineligible for, standard curative therapy in the recurrent setting. expansion only * participant must have advanced (unresectable) or metastatic, histologically confirmed diagnosis of selected solid cancers. key exclusion criteria: * has significant cardiovascular impairment within 6 months prior to the first dose of trial drug, including presence of unstable angina, myocardial infarction, congestive heart failure (new york heart association \[nyha\] class iii and iv), or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy. * known unstable central nervous system (cns) metastases or any active or history of carcinomatous meningitis. * has been exposed to any of the following prior therapies within the specified timeframes: * prior therapy with a compound targeting the same targets as gen1078 or any cell-based therapies. * radiotherapy within 14 days prior to c1d1. palliative radiotherapy of bone metastases up to 7 days prior to c1d1 will be allowed. * treatment with any investigational or non-investigational anticancer agent (including investigational vaccines) or used an invasive investigational medical device within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first dose of gen1078. * chemotherapy within 2 weeks prior to the first dose of gen1078. * prophylaxis with live, attenuated vaccines within 28 days prior to first dose of gen1078; or prophylaxis with the first and/or subsequent injection(s) of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) nucleic acid vaccine within 14 days prior to first dose of gen1078. * chronic systemic immunosuppressive treatment, including corticosteroids, ie, prednisone \&gt;10 milligrams (mg) daily (or equivalent) or a cumulative dose \&gt;140 mg prednisone within 14 days (or equivalent) before the first dose of gen1078. replacement therapy (eg, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted. * has received granulocyte colony-stimulating factor (g-csf) or granulocyte/macrophage colony stimulating factor support within 2 weeks prior to the first dose gen1078 or being chronically transfusion dependent. * has received other t-cell activating surface marker. note: prior treatment with anti-t-cell ig and itim domain (atigit), anti-programmed cell death protein 1 (apd1), anti-programmed death-ligand 1 (apdl1), anti-lymphocyte activation gene 3 protein (alag3), anti-cytotoxic t-lymphocyte-associated protein 4 (actla-4) is allowed. * the initiation of growth factors and bisphosphonates is not allowed during the first 4 weeks of gen1078 administration, unless agreed upon by the investigator and sponsor medical monitor. however, the use of receptor activator of nuclear factor kappa-β ligand (rank-l) inhibitors and bisphosphonates (if on stable dose for at least 4 weeks) is permitted while participating in this trial. note: other protocol-defined inclusion/exclusion criteria may apply.