A Study of JNJ-87890387 for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
JNJ-87890387
DrugJNJ-87890387 will be administered.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: JNJ-87890387Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to first 21 days after administration of the first full treatment dose2
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.
Time frame
Up to 2 years 9 monthsSecondary outcomes
1
Part 1 and Part 2: Serum Concentration of JNJ-87890387
Serum concentration of JNJ-87890387 will be reported.
Time frame
Up to 2 years 9 months2
Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387
Cmax is defined as maximum observed serum concentration of JNJ-87890387.
Time frame
Up to 2 years 9 months3
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.
Time frame
Up to 2 years 9 months4
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.
Time frame
Up to 2 years 9 monthsOther outcomes
1
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.
Time frame
Up to 2 years 9 months2
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.
Time frame
Up to 2 years 9 monthsSponsors and contacts
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Source ClinicalTrials.gov