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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

Must not have

Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody

Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My cancer can be measured or evaluated.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I do not have any severe ongoing illnesses that would interfere with the study.

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I haven't had cancer treatment or investigational drugs in the last 14 days to 28 days.

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I experienced severe side effects from past immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

Fatigue

33%

Thrombocytopenia

33%

Anaemia

33%

Vomiting

33%

Nausea

22%

Chills

22%

Paraesthesia

22%

Cough

22%

Hypertension

22%

Lymphopenia

22%

Diarrhoea

22%

Asthenia

11%

Epistaxis

11%

Rhinitis

11%

Lipase Increased

11%

Body Tinea

11%

Folate Deficiency

11%

Cellulitis

11%

Herpes Simplex

11%

Pruritus

11%

Oedema Peripheral

11%

Dyspnoea

11%

Rhinitis Allergic

11%

Vertigo

11%

Weight Decreased

11%

Back Pain

11%

Throat Irritation

11%

Hypomagnesaemia

11%

Musculoskeletal Pain

11%

Proteinuria

11%

Hyperglycaemia

11%

Dehydration

11%

Hyperamylasaemia

11%

Viral Upper Respiratory Tract Infection

11%

Muscle Spasms

11%

Dysphonia

11%

Bradycardia

11%

Encephalitis Autoimmune

11%

Osteomyelitis

11%

Vulvovaginal Candidiasis

11%

Muscle Atrophy

11%

Myopathy

11%

Dizziness

11%

Leukopenia

11%

Pyrexia

11%

Upper Respiratory Tract Infection

11%

Constipation

11%

Influenza Like Illness

11%

Febrile Neutropenia

11%

Septic Shock

11%

Acute Kidney Injury

11%

Corneal Degeneration

11%

Dry Mouth

11%

Dyspepsia

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Daratumumab + JNJ-63723283

Part 2: Daratumumab (Arm A)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met