A Study of JNJ-89862175 for Treatment of Advanced Solid Tumors

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  JNJ-89862175

  Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1.

  Drug: JNJ-89862175

Interventions

• DrugJNJ-89862175

  JNJ-89862175 will be administered.

Primary outcomes

1. Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)

   The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.

   Time frame: Up to 21 days

2. Part 1: Number of Participants with Adverse Events (AEs) by Severity

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 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 and 10 months

3. Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. 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 and 10 months

Secondary outcomes

1. Objective Response Rate (ORR)

   ORR is defined as the percentage of participants who have best overall response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v.) 1.1.

   Time frame: Up to 2 years and 10 months

2. Progression Free Survival (PFS)

   PFS is defined as the time from the first dose of JNJ-89862175 to either disease progression according to RECIST v. 1.1, or death due to any cause, whichever comes first.

   Time frame: Up to 2 years and 10 months

3. Duration of Response (DOR)

   DOR is defined as the time 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.

   Time frame: Up to 2 years and 10 months

4. Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)

   Serum samples will be analyzed to determine Cmax of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite.

   Time frame: Up to 2 years and 10 months

5. Observed Plasma Concentration Immediately Before Next Dose Administration (Ctrough) of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)

   Ctrough of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

   Time frame: Up to 2 years and 10 months

6. Time to Reach Cmax (Tmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)

   Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

   Time frame: Up to 2 years and 10 months

7. Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)

   AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

   Time frame: Up to 2 years and 10 months

8. Accumulation Ratio of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)

   Accumulation ratio of JNJ-89862175 with total and conjugated antibody, free payload and major metabolite will be reported.

   Time frame: Up to 2 years and 10 months

9. Number of Participants With Anti JNJ-89862175 Antibodies

   Serum samples will be analyzed for the detection of anti-JNJ-89862175 antibodies using a validated assay method.

   Time frame: Up to 2 years and 10 months

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu