Description:
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and
maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of
JNJ-70218902 RP2D(s) in Part 2.
Title
- Brief Title: A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
- Official Title: A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CR108765
- SECONDARY ID:
2019-004885-16
- SECONDARY ID:
70218902EDI1001
- NCT ID:
NCT04397276
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| JNJ-70218902 | | Part 1: Dose Escalation |
Purpose
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and
maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of
JNJ-70218902 RP2D(s) in Part 2.
Detailed Description
JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by
attaching to cancer cells and activating immune cells to kill these cancer cells.This study
will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will
enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study
evaluations will include safety, pharmacokinetics, biomarkers and immunogenicity evaluations.
This study is divided into 3 periods: screening, treatment and post-treatment. The total
duration of the study will be 2.5 years approximately.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1: Dose Escalation | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. | |
| Part 2: Dose Expansion | Experimental | Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1. | |
Eligibility Criteria
Inclusion Criteria:
- Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic
confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine
features is allowed
- Measurable or evaluable disease
- Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or
chemotherapy
- If the participant is receiving treatment with gonadotropin-releasing hormone agonists
or antagonist analogs (GnRH), this therapy must have been initiated prior to first
dose of study drug and must be continued throughout the study
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Adequate organs functions
- Archived tissue at baseline are requested
- Participants with accessible lesions enrolled in selected cohorts in Part 1 and 2 will
undergo fresh tumor biopsies
Exclusion Criteria:
- Known brain metastases
- Concurrent use of any other anticancer treatment or investigational agent for the
treatment of advanced disease
- Toxicities related to prior anticancer treatments have not returned to Grade less than
or equal to (<=) 1 or baseline, except for alopecia and vitiligo
- Solid organ or bone marrow transplantation
- Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
- Certain comorbidities
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Secondary Outcome Measures
| Measure: | Maximum Observed Serum Concentration (Cmax) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Cmax is the maximum observed serum concentration of JNJ-70218902. |
| Measure: | Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Tmax is defined as time to reach maximum observed serum concentration. |
| Measure: | Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2. |
| Measure: | Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval. |
| Measure: | Minimum Observed Serum Concentration (Cmin) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Cmin is the minimum observed serum concentration of JNJ-70218902. |
| Measure: | Accumulation Ratio (RA) of JNJ-70218902 |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose. |
| Measure: | Systemic Cytokine Concentrations |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Cytokines concentration will be measured for biomarker assessment. |
| Measure: | Serum Prostate Specific Antigen (PSA) Concentration |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Serum prostate specific antigen (PSA) concentration will be measured. |
| Measure: | Number of Participants With Anti-JNJ-70218902 Antibodies |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Number of participants with anti-JNJ-70218902 antibodies will be assessed. |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3). |
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 2.5 years |
| Safety Issue: | |
| Description: | Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Janssen Research & Development, LLC |
Trial Keywords
- metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Prostate Cancer
Last Updated
February 26, 2021
