Recruiting NCT06178614
A Study of JNJ-87890387 for Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JNJ-87890387.
- Who it may be relevant to
- Registry conditions: Neoplasms, Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors
Overview
The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).
Interventions
- Drug JNJ-87890387
JNJ-87890387 will be administered.
Primary outcome measures
- Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) [Time frame: Up to first 21 days after administration of the first full treatment dose]
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years 9 months]
Secondary outcome measures (10)
- Part 1 and Part 2: Serum Concentration of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Accumulation Ratio of JNJ-87890387 [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Objective Response Rate (ORR) [Time frame: Up to 2 years 9 months]
- Part 1 and Part 2: Duration of Response (DOR) [Time frame: Up to 2 years 9 months]
Eligibility criteria
Inclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Start Midwest — Grand Rapids
- Sarah Cannon Research Institute — Nashville
France · 2 centers
- Centre Leon Berard — Lyon
- Institut Gustave Roussy — Villejuif
Spain · 2 centers
- Hosp Univ Vall D Hebron — Barcelona
- Hosp. Univ. 12 de Octubre — Madrid
Identifiers
NCT: NCT06178614 · CR109339 · 87890387STM1001 · 2023-505358-16-00