A Phase 1 Study of JNJ-78306358, a T Cell Redirecting Bispecific Antibody Targeting HLA-G for Advanced Stage Solid Tumors

  • End date
    Aug 21, 2024
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 17 September 2022
growth factor
treatment regimen
primary cancer
solid tumor


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.

Condition Neoplasms
Treatment JNJ-78306358
Clinical Study IdentifierNCT04991740
SponsorJanssen Research & Development, LLC
Last Modified on17 September 2022


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types
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
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
Part 2: at least one measurable lesion per Response Evaluation Criteria in
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Solid Tumors (RECIST) version 1.1. Participants with ovarian cancer without a
Selected participants in pharmacokinetics/pharmacodynamic (PK/PD) cohorts and in Part 2 must agree to undergo the mandatory tumor biopsies
measurable lesion must have disease evaluable per RECIST version1.1 (example
ascites) or have Cancer antigen 125 (CA 125) greater than (>) 2upper limit of
normal (ULN) within 2 weeks prior to first dose of study drug

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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