JNJ-63723283 for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Hosp. Gral. Univ. Gregorio Marañon, Madrid, Spain
JNJ-63723283 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug can shrink tumors in people with cancer.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether JNJ-63723283 will improve 3 primary outcomes and 19 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 2 years and 5 months.

Approximate 2.5 years
Clinical Benefit Rate (CBR) per RECIST v1.1
Clinical Benefit Rate per irRC
Duration of Response (DOR) per RECIST v1.1
Duration of Response (DOR) per irRC
Maximum Observed Serum Concentration (Cmax)
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC)
Overall Survival (OS)
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 1 and 2: Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2])
Parts 1 and 2: Total Systemic Clearance of (CL)
Parts 1 and 2: Volume of Distribution at Steady-State (Vss)
Parts 1, 2 and 3: Elimination Half-Life (t1/2)
Parts 1, 2 and 4: Accumulation Ratio (R)
Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations
Progression-free Survival (PFS) per RECIST v1.1
Progression-free Survival (PFS) per irRC
Year 2
Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t])
Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])
Parts 3 and 4: Concentration just Prior to the Beginning of at the end of a Dosing Interval (Ctrough)
Parts 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity])

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Part 2: Daratumumab (Arm A)
Thrombocytopenia
100%
Hypomagnesaemia
0%
Pruritus
0%
Myalgia
0%
Cough
0%
Dizziness
0%
Musculoskeletal Pain
0%
Dyspepsia
0%
Nausea
0%
Acute Kidney Injury
0%
Chills
0%
Oedema Peripheral
0%
Dry Mouth
0%
Leukopenia
0%
Back Pain
0%
Diarrhoea
0%
Viral Upper Respiratory Tract Infection
0%
Body Tinea
0%
Encephalitis Autoimmune
0%
Anaemia
0%
Pyrexia
0%
Herpes Simplex
0%
Osteomyelitis
0%
Rhinitis
0%
Febrile Neutropenia
0%
Hyperglycaemia
0%
Asthenia
0%
Lymphopenia
0%
Muscle Atrophy
0%
Muscle Spasms
0%
Rhinitis Allergic
0%
Proteinuria
0%
Neutropenia
0%
Influenza Like Illness
0%
Septic Shock
0%
Vulvovaginal Candidiasis
0%
Bradycardia
0%
Constipation
0%
Upper Respiratory Tract Infection
0%
Weight Decreased
0%
Vertigo
0%
Folate Deficiency
0%
Corneal Degeneration
0%
Fatigue
0%
Dehydration
0%
Paraesthesia
0%
Vomiting
0%
Epistaxis
0%
Dysphonia
0%
Hypertension
0%
Cellulitis
0%
Hyperamylasaemia
0%
Myopathy
0%
Dyspnoea
0%
Throat Irritation
0%
Lipase Increased
0%
This histogram enumerates side effects from a completed 2021 Phase 2 & 3 trial (NCT03357952) in the Part 2: Daratumumab (Arm A) ARM group. Side effects include: Thrombocytopenia with 100%, Hypomagnesaemia with 0%, Pruritus with 0%, Myalgia with 0%, Cough with 0%.

Trial Design

2 Treatment Groups

Control
JNJ-63723283

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. JNJ-63723283 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

JNJ-63723283
Drug
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), 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 to evaluate additional doses.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetrelimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximate 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximate 2.5 years for reporting.

Closest Location

UPMC Cancer Centers - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
Has thyroid function laboratory values within normal range
Women of childbearing potential must have a negative serum pregnancy test
Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy

Patient Q&A Section

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

Can cancer be cured?

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Cancers are usually curable only when they have begun to spread to other parts of the body; curing cancer entails removing the existing cancer from the body. Thus, there are few ways to cure cancer. A cancer can be cured only when all the cells that have developed a tumor are removed. In rare cases cancer can be completely cured with surgery, radiation, chemotherapy and targeted therapy. To date there is insufficient evidence to recommend any strategy (with or without treatment) or cure. Current research in this area is limited.

Unverified Answer

What causes cancer?

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The cause of cancer remains elusive despite the availability of a large body of evidence for and against several proposed causes. We suspect that the vast majority of cancers are caused by a complex interaction between genetic predisposition and environmental factors, which, we argue, explains the high background incidence of cancer across the human population. These predisposing factors can be measured and/or simulated within the lab to produce cancers that mimic natural disease that cause or are caused by the natural disease.

Unverified Answer

What are the signs of cancer?

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Surgical interventions such as biopsy, blood tests, and x-rays may indicate an underlying cancer, and the presence of one or combined signs of cancer indicate a greater likelihood of cancer.

Unverified Answer

What are common treatments for cancer?

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In both the current and historical periods, physicians have treated cancer using a variety of methods. Recent discoveries or advances often result in changes to the standard therapy.

Unverified Answer

How many people get cancer a year in the United States?

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About 17 million Americans will develop cancer in 2008, with nearly 70% of cancer diagnoses occurring after age 75. At the same time, the prevalence of diabetes, at 6.7 million children per year and obesity, at 6.8 million children per year, show the growing burden on public health. These diseases will have increased impacts on American society as a whole, as well as on the economy, as they have the potential to curtail productive years.

Unverified Answer

What is cancer?

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Most cancer cases are due to the initiation and growth of uncontrolled cell divisions resulting in the formation of cancer. The incidence of cancer is increasing with a global increase in age, lifestyle, and diet. Some of these risk factors are the result of environmental and medical exposure to ionizing radiation, tobacco, drug abuse, alcohol, or other chemicals. Smoking in particular gives a more rapid onset of carcinogenesis than other known carcinogens, and some people are more susceptible to lung cancer from tobacco smoke than others. People who use cannabis are 50% less likely to develop cancer of the urinary bladder than those who do not use it.

Unverified Answer

Does jnj-63723283 improve quality of life for those with cancer?

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These data show beneficial effects of JNJ-63723283 on a variety of measures of QOL, with improvements as early as 12 weeks and maintained over time. These data support the use of cancer chemotherapy under treatment conditions that are compatible with JNJ-63723283.

Unverified Answer

What are the latest developments in jnj-63723283 for therapeutic use?

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Currently the therapeutic use of jnj-63723283 and its derivatives in humans and animal models has produced dramatic results. In future the drug promises to be a more effective and less toxic therapy for cancers.

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Is jnj-63723283 safe for people?

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Jnj-63723283 was well tolerated in both Phase 1 studies. The Phase 2 results in one study are consistent with the expected safety/efficacy relationship of a targeted therapy.

Unverified Answer

How does jnj-63723283 work?

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Recent findings suggest that the J-Wnt antagonist Jnj-63723283 shows strong anticancer activity that requires active Wnt signaling to achieve. Further studies are warranted to investigate the activity and utility of Jnj-63723283 as a treatment and/or diagnostic tool for a variety of malignancies.

Unverified Answer

What is the latest research for cancer?

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Results should be compared with national and international databases (e.g., Surveillance, Epidemiology, and End Results); results should be compared with other cancer prevention and screening programs; and results should be compared with the cost/benefit of screening the whole population.

Unverified Answer

What does jnj-63723283 usually treat?

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In most cases, Jnj-63723283 was not effective for treating specific cancer types or cancer types in specific organs. However, because many patients with cancer suffer from severe pain and other debilitating symptoms, the role of jnj-63723283 and its effects against pain and other debilitating symptoms could not be easily and certainly concluded in many cases. Further studies on the use of jnj-63723283 for treating cancer patients are necessary.

Unverified Answer
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