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Monoclonal Antibody

Anti-PD-1 Therapy for Advanced Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parts 1 to 4: Have evaluable disease
Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 6 months
Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is effective and how it works against different types of cancer.

Who is the study for?
This trial is for adults with certain advanced cancers, including lung, melanoma, renal, bladder, and colorectal cancers. Participants must be in good physical condition (ECOG status 0 or 1), have normal thyroid function, not be pregnant or breastfeeding, and agree to study restrictions. Tissue samples are required for some parts of the study.Check my eligibility
What is being tested?
The trial is testing JNJ-63723283's safety and effectiveness at different doses in treating various advanced cancers. It aims to find the best dose for Phase 2 trials and see how well it works against specific cancer types.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include those common to anti-PD-1 therapies such as fatigue, skin reactions, inflammation of organs like lungs or intestines (pneumonitis or colitis), hormonal gland issues (like thyroid dysfunction), and immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured or evaluated.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT)
Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors
Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])
Secondary outcome measures
Parts 1 and 2: Accumulation Ratio (R)
Serum
Parts 1 and 2: Total Systemic Clearance of (CL)
+17 more

Side effects data

From 2021 Phase 2 & 3 trial • 10 Patients • NCT03357952
44%
Neutropenia
33%
Myalgia
33%
Anaemia
33%
Thrombocytopenia
33%
Vomiting
33%
Fatigue
33%
Nausea
22%
Paraesthesia
22%
Cough
22%
Hypertension
22%
Lymphopenia
22%
Diarrhoea
22%
Asthenia
22%
Chills
11%
Upper Respiratory Tract Infection
11%
Cellulitis
11%
Weight Decreased
11%
Hyperamylasaemia
11%
Hyperglycaemia
11%
Hypomagnesaemia
11%
Back Pain
11%
Muscle Atrophy
11%
Muscle Spasms
11%
Myopathy
11%
Dizziness
11%
Proteinuria
11%
Dysphonia
11%
Dyspnoea
11%
Epistaxis
11%
Rhinitis Allergic
11%
Throat Irritation
11%
Pruritus
11%
Septic Shock
11%
Acute Kidney Injury
11%
Leukopenia
11%
Bradycardia
11%
Vertigo
11%
Corneal Degeneration
11%
Constipation
11%
Influenza Like Illness
11%
Lipase Increased
11%
Dehydration
11%
Folate Deficiency
11%
Musculoskeletal Pain
11%
Encephalitis Autoimmune
11%
Dry Mouth
11%
Dyspepsia
11%
Oedema Peripheral
11%
Pyrexia
11%
Viral Upper Respiratory Tract Infection
11%
Vulvovaginal Candidiasis
11%
Body Tinea
11%
Febrile Neutropenia
11%
Herpes Simplex
11%
Osteomyelitis
11%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Daratumumab + JNJ-63723283
Part 2: Daratumumab (Arm A)

Trial Design

1Treatment groups
Experimental Treatment
Group I: JNJ-63723283Experimental Treatment1 Intervention
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous [SC] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-63723283
2018
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,309 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,495 Total Patients Enrolled

Media Library

JNJ-63723283 (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT02908906 — Phase 1 & 2
Tumors Research Study Groups: JNJ-63723283
Tumors Clinical Trial 2023: JNJ-63723283 Highlights & Side Effects. Trial Name: NCT02908906 — Phase 1 & 2
JNJ-63723283 (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02908906 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor currently accept new volunteers?

"Clinicaltrials.gov shows that this experiment is currently recruiting participants, having been initially posted on the 21st of November 2016 and last modified on the 3rd of November 2022."

Answered by AI

Has JNJ-63723283 been the focus of prior research?

"Presently, 8 research projects are underway exploring JNJ-63723283. One of them is currently in the third stage of clinical trials. The predominant site for this medication's experiments is Brasschaat, Quebec; however 1000 additional sites have joined to lend their aid."

Answered by AI

What aims does this research endeavor aim to accomplish?

"The primary endpoint of this medical trial, which will be tracked for up to two years and six months, is the Average Concentration (Cavg) of JNJ-63723283. Secondary objectives consist of Ctrough, ORR per RECIST V1.1, as well as AEs observed in participants taking the medication."

Answered by AI

How many participants are currently engaged in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which first appeared on November 21st 2016, is actively recruiting participants. 600 patients must be recruited from 1 medical site."

Answered by AI

Is this the inaugural trial to investigate such a treatment?

"JNJ-63723283 has been undergoing clinical trials since 2016, when Janssen Research & Development, LLC sponsored the original trial with 600 participants. Following these successful Phase 1 and 2 studies, 8 live experiments are currently taking place in 35 countries across 92 cities."

Answered by AI
Recent research and studies
~50 spots leftby Mar 2025