Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors
Interventional
Phase 1
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
décembre 2023
avril 2028
02 septembre 2025
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of
JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Capucine BALDINI | 12/06/2024 12:49:19 | Contacter | ||
Critères
Tous
- Have histologically or cytologically confirmed, metastatic, or unresectable solid
tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or
papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine
carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma
- Have measurable or evaluable disease: Part 1- Either measurable or evaluable
disease; Part 2- At least 1 measurable lesion per RECIST v1.1. Participants with
ovarian cancer without a measurable lesion must have disease evaluable per Response
Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125
greater than (>) 2*upper limit of normal (ULN) during screening
- All participants in Part 1 and Part 2 must consent to provide an archived tumor
tissue sample at screening
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at
screening
- Be willing and able to adhere to the lifestyle restrictions specified in this
protocol.
Exclusion Criteria:
- Active Central Nervous System (CNS) involvement with the exception of locally
treated brain metastases that are clinically stable and asymptomatic for > 2 weeks
and who are off or receiving low-dose corticosteroid treatment (less than or equal
to [<=]10 milligrams [mg] prednisone or equivalent) for at least 2 weeks prior to
start of study treatment
- Toxicity from prior anticancer therapy that has not resolved to Grade <=1 (except
alopecia, vitiligo, Grade <=2 peripheral neuropathy, or endocrinopathies that are
stable on hormone replacement)
- History of Grade greater than or equal to (>=) 2 immune-related AE(s) with prior
immunotherapy that led to discontinuation of previous immunotherapy with the
exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and
that did not recur following rechallenge. Endocrinopathies that are stable on
hormone replacement therapy or that have resolved are allowed.
- History of solid organ or hematologic stem cell transplantation
- Any episode of partial or complete bowel obstruction requiring hospitalization
within 30 days prior to first dose of study treatment