A Study of JNJ-87890387 for Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178614
• Other study ID #: CR109339
• Secondary ID: 2023-505358-16-0
• Status: Recruiting
• Phase: Phase 1
• Start date: December 14, 2023
• Est. completion date: September 11, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 11, 2026
• Est. primary completion date: September 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• JNJ-87890387
JNJ-87890387 will be administered.

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	Institut Gustave Roussy	Villejuif
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. 12 de Octubre	Madrid
United States	Start Midwest	Grand Rapids	Michigan
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part 1 and Part 2: Time to Response (TTR)	TTR is defined for the responders as the time from the date of the first dose of JNJ-87890387 to the date of the first documented response.	Up to 2 years 9 months
Other	Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate	CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125, maintained for at least 4 weeks. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days.	Up to 2 years 9 months
Primary	Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)	Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.	Up to first 21 days after first dose
Primary	Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity	An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Serum Concentration of JNJ-87890387	Serum concentration of JNJ-87890387 will be reported.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387	Cmax is defined as maximum observed serum concentration of JNJ-87890387.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387	Tmax is defined as the time to reach maximum observed serum concentration of JNJ-87890387.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387	AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387	AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387	Cmin is defined as the minimum observed serum concentration of JNJ-87890387.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Accumulation Ratio of JNJ-87890387	Accumulation ratio of JNJ-87890387 will be reported. The R is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies	Number of participants with presence of anti-JNJ-87890387 antibodies will be reported.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Objective Response Rate (ORR)	ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) maintained for at least 4 weeks.	Up to 2 years 9 months
Secondary	Part 1 and Part 2: Duration of Response (DOR)	DOR is defined as the duration from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST v. 1.1, or death due to any cause, whichever occurs first.	Up to 2 years 9 months