Clinical trial NCT06178614: A Study of JNJ-87890387 for Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-12-21
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
timeFrame: Up to first 21 days after first dose
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: Up to 2 years 9 months
Secondary outcomes:
measure: Part 1 and Part 2: Serum Concentration of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Accumulation Ratio of JNJ-87890387
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Objective Response Rate (ORR)
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Duration of Response (DOR)
timeFrame: Up to 2 years 9 months
Other outcomes:
measure: Part 1 and Part 2: Time to Response (TTR)
timeFrame: Up to 2 years 9 months
measure: Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate
timeFrame: Up to 2 years 9 months
Locations:
city: Grand Rapids
country: United States
facility: Start Midwest
state: Michigan
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Lyon
country: France
facility: Centre Leon Berard
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: