a study of jnj-78306358 in participants with advanced stage solid tumors

Conditions: Neoplasms

Summary: the purpose of this study is to determine the recommended phase 2 dose (rp2d) regimen(s) of jnj-78306358 in part 1 (dose escalation) and to determine the safety of jnj-78306358 at the rp2d regimen(s) in part 2 (dose expansion).

jnj-78306358 is a bispecific antibody binding to cd3 on t cells and human leukocyte antigen g (hla-g) on cancer cells. the study consists of a screening phase, a treatment phase, and a post-treatment follow-up phase. study evaluations include safety, pharmacokinetics, biomarkers, immunogenicity, and efficacy (disease evaluations). the total study duration will be up to 2 years 4 months.

Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types: a. renal cell carcinoma (rcc): clear cell or papillary carcinoma, b. ovarian cancer: high grade serous epithelial ovarian; primary peritoneal or fallopian tube cancer; 1. low grade or non-serous histologies are not allowed; c. colorectal cancer (crc); d. other tumor types (including lung adenocarcinoma, endometrial cancer, and pancreas cancer) may be enrolled with sponsor approval * measurable or evaluable disease: a. part 1: either measurable or evaluable disease; b. part 2: at least one measurable lesion per response evaluation criteria in solid tumors (recist) version 1.1. participants with ovarian cancer without a measurable lesion must have disease evaluable per recist version1.1 (example ascites) or have cancer antigen 125 (ca 125) greater than (\>) 2\*upper limit of normal (uln) within 2 weeks prior to first dose of study drug * progressed during or after the following prior therapies for metastatic disease, unless participant was ineligible to receive them: a) rcc: clear cell histology: an antiangiogenic agent and an immune checkpoint inhibitor, administered as 1 or more lines of therapy. for papillary renal carcinoma 1 line of systemic therapy; b. crc: at least 2 lines of therapy including a fluoropyrimidine, oxaliplatin, and irinotecan given with or without antiangiogenic therapies or epidermal growth factor receptor (egfr) antibodies. in addition, prior treatment with anti-programmed cell death protein 1 (pd1) antibody is required for high microsatellite instability (msi-h) crc; c. ovarian cancer: at least 2 lines of therapy, including at least 1 line with platinum. maintenance therapy after completion of platinum-containing regimen, example with bevacizumab or a poly- adenosine di-phosphate (adp) ribose polymerase inhibitor will not count as a separate line of therapy; d. other tumor types: at least 2 lines of systemic therapy * eastern cooperative oncology group (ecog) performance status grade of 0 or 1 * selected participants in pharmacokinetics/pharmacodynamic (pk/pd) cohorts and in part 2 must agree to undergo the mandatory tumor biopsies exclusion criteria: * active central nervous system involvement * toxicity from prior anticancer therapy has not resolved to baseline levels or to grade less than or equal to (\<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be grade 2) * clinically significant pulmonary compromise * autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug * solid organ or bone marrow transplantation

Keywords: kidney cancer ovarian cancer colorectal cancer