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).

A Study of JNJ-87890387 for Advanced Solid Tumors

Neoplasms

Cancer

Advanced Solid Tumors

Advanced Solid Malignancies

Advanced Solid Tumor

Lung Cancer

Solid Tumor, Adult

Colorectal cancer

Advanced Stage Solid Tumors

Gastrointestinal Cancer

Genitourinary Cancer

Renal cell carcinoma. Clear cell or papillary carcinoma

Renal cancer

Ovarian cancer

Endometrioid ovarian cancer

Uterine cancer

Lung adenocarcinoma

Endometrioid uterine carcinoma

JNJ-87890387

A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors

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.

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.

Serum concentration of JNJ-87890387 will be reported.

Cmax is defined as maximum observed serum concentration of JNJ-87890387.

Tmax is defined as the time to reach maximum observed serum concentration 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.

AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387.

Cmin is defined as the minimum observed serum concentration of JNJ-87890387.

Accumulation ratio of JNJ-87890387 will be reported. The AR is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.

Number of participants with presence of anti-JNJ-87890387 antibodies will be reported.

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.

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.

In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.

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).

Start Midwest

Sarah Cannon Research Institute

Centre Leon Berard

Institut Gustave Roussy

Hosp Univ Vall D Hebron

Hosp. Univ. 12 de Octubre

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.

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.

Tmax is defined as the time to reach maximum observed serum concentration 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.

AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0
to time tau 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.

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.

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.

In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be
escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been
identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the
RP2D regimen(s) determined in Part 1.

A Study of JNJ-87890387 for Advanced Solid Tumors

Trials at a glance

Trials at a glance

A Study of JNJ-87890387 for Advanced Solid Tumors

Outcome measures

Primary outcome measures

Secondary outcome measures