Advanced Solid Tumors, Neoplasms
Conditions
Brief summary
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
DRUGJNJ-87890387
JNJ-87890387 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) | Up to first 21 days after administration of the first full treatment dose | 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. |
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity | Up to 2 years 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Serum Concentration of JNJ-87890387 | Up to 2 years 9 months | Serum concentration of JNJ-87890387 will be reported. |
| Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387 | Up to 2 years 9 months | Cmax is defined as maximum observed serum concentration of JNJ-87890387. |
| Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387 | Up to 2 years 9 months | Tmax is defined as the time to reach maximum observed serum concentration of JNJ-87890387. |
| Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387 | Up to 2 years 9 months | AUC(t1-t2) is defined as area under the serum concentration versus time curve from time t1 to time t2 of JNJ-87890387. |
| Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387 | Up to 2 years 9 months | AUC(0-tau) is defined as area under the serum concentration versus time curve from time 0 to time tau of JNJ-87890387. |
| Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387 | Up to 2 years 9 months | Cmin is defined as the minimum observed serum concentration of JNJ-87890387. |
| Part 1 and Part 2: Accumulation Ratio of JNJ-87890387 | Up to 2 years 9 months | 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. |
| Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies | Up to 2 years 9 months | Number of participants with presence of anti-JNJ-87890387 antibodies will be reported. |
| Part 1 and Part 2: Objective Response Rate (ORR) | Up to 2 years 9 months | 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. |
| Part 1 and Part 2: Duration of Response (DOR) | Up to 2 years 9 months | 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. |
Countries
France, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed