A Study of JNJ-87890387 for Advanced Solid Tumors
- Registration Number
- NCT06178614
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 158
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-87890387 JNJ-87890387 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.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) Up to first 21 days after first 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 Outcome Measures
Name Time Method 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: 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.
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 R 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.
Trial Locations
- Locations (6)
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Start Midwest
🇺🇸Grand Rapids, Michigan, United States
Centre Leon Berard
🇫🇷Lyon, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States