NeoplasmPhase 1NCT03547037
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers
A Phase 1 study testing JNJ-63723283 and Erdafitinib in people with Neoplasm, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.
Trial summary
The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- JNJ-63723283 and Erdafitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesJapan
- Study dates
- 31 Aug 2018to 4 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment options. Participants with solid tumor(s) for which anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Thyroid function laboratory values within normal range
- A woman must be: a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especially participants receiving erdafitinib must agree to use two contraceptive methods and one must be user-independent method; Examples of highly effective contraceptives include: user-independent methods: intrauterine device (IUD) or intrauterine contraceptive system (IUS) and user-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception or progesterone-containing hormonal contraception. c) Agree not to donate eggs (ova, oocytes), during the study and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for 5 months following discontinuation of JNJ-63723283 or 5 months following discontinuation of erdafitinib, whichever is longer
Who cannot join
- Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2 antibody within 30 days of first study drug administration and/or has an ongoing Grade 2 or higher immunotherapy-related toxicity. If the subject has an experience of treatment with these agents, the subject must not have had severe immunotherapy-related toxicity
- History of or concurrent interstitial lung disease
- Active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
- Grade 3 or higher toxicity effects from previous treatment with immunotherapy
- Has taken immunosuppressive doses of systemic medications, such as corticosteroids doses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent), within 2 weeks before the planned first dose of study drug
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
National Cancer Center Hospital
Chūōku, 104 0045
National Cancer Center Hospital East
Kashiwa, 277 8577
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers
The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).
- Conditions
- Neoplasm
- Being tested
- JNJ-63723283, Erdafitinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-63723283Drug
Also called Cetrelimab
JNJ-63723283 will be administered intravenously.
ErdafitinibDrug
Erdafitinib will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: JNJ-63723283 (Monotherapy) | Experimental | Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM). Receives: Drug: JNJ-63723283 |
| Phase 1b: Erdafitinib Combination | Experimental | Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM. Receives: Drug: JNJ-63723283; Drug: Erdafitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.
Measured: Up to 6 weeks (maximum)
Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
Measured: Up to 6 weeks (maximum)
Secondary outcomes (14)
Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Severity of Adverse Event will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death) with Grades as follows: Grade 1 (Mild) Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death).
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability
Number of participants with clinically significant changes in the vital signs including blood pressure, pulse rate, and body temperature will be reported.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, coagulation panel, serum chemistry panel, endocrine panel, serology and pregnancy test [women only]) will be reported.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability
Number of participants with electrocardiogram (ECG) abnormalities will be reported.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283
The Cmax is the maximum observed serum concentration.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283
Ctrough is the serum concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283
The Tmax is defined as actual sampling time to reach maximum observed serum concentration.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283
The AUC(t1-t2) is the area under the serum concentration-time curve between 2 defined sampling points, t1 and t2.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283
T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283
CL is a quantitative measure of the rate at which JNJ-63723283 is removed from the body.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution is the apparent volume of distribution at steady-state.
Measured: Approximately up to 3 years
Phase 1b: Cmax of Erdafitinib
The Cmax is the maximum observed plasma concentration.
Measured: Approximately up to 3 years
Phase 1b: Ctrough of Erdafitinib
Ctrough is the plasma concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen.
Measured: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies
Number of participants with anti-JNJ 63723283 antibodies will be assessed.
Measured: Approximately up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start31 Aug 2018
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547037
- Sponsor's protocol ID
- CR108471
- Other IDs
- 63723283LUC1002
- Status last verified
- Apr 2025
- First submitted
- 24 May 2018
- Last updated
- 28 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT03547037
- Acronym / sponsor ID
- CR108471
- Conditions
- Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: JNJ-63723283 (Monotherapy) | Experimental | Drug: JNJ-63723283Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM). |
| Phase 1b: Erdafitinib Combination | Experimental | Drug: JNJ-63723283, Drug: ErdafitinibParticipants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment options. Participants with solid tumor(s) for which anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Thyroid function laboratory values within normal range
- A woman must be: a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especially participants receiving erdafitinib must agree to use two contraceptive methods and one must be user-independent method; Examples of highly effective contraceptives include: user-independent methods: intrauterine device (IUD) or intrauterine contraceptive system (IUS) and user-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception or progesterone-containing hormonal contraception. c) Agree not to donate eggs (ova, oocytes), during the study and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for 5 months following discontinuation of JNJ-63723283 or 5 months following discontinuation of erdafitinib, whichever is longer
Key exclusion criteria (5 listed)
- Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2 antibody within 30 days of first study drug administration and/or has an ongoing Grade 2 or higher immunotherapy-related toxicity. If the subject has an experience of treatment with these agents, the subject must not have had severe immunotherapy-related toxicity
- History of or concurrent interstitial lung disease
- Active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
- Grade 3 or higher toxicity effects from previous treatment with immunotherapy
- Has taken immunosuppressive doses of systemic medications, such as corticosteroids doses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent), within 2 weeks before the planned first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-63723283Also: CetrelimabJNJ-63723283 will be administered intravenously. | Drug | Phase 1a: JNJ-63723283 (Monotherapy), Phase 1b: Erdafitinib Combination |
| ErdafitinibErdafitinib will be administered orally. | Drug | Phase 1b: Erdafitinib Combination |
Primary outcome
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: Up to 6 weeks (maximum)
The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.
Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: Up to 6 weeks (maximum)
Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
14 secondary outcomes
Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283
Time frame: Approximately up to 3 years
Phase 1b: Cmax of Erdafitinib
Time frame: Approximately up to 3 years
Phase 1b: Ctrough of Erdafitinib
Time frame: Approximately up to 3 years
Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies
Time frame: Approximately up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2025.
Related trials for Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-63723283 and Erdafitinib in people with Neoplasm, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT) (time frame: Up to 6 weeks (maximum)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2025.