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MAPK Pathway Inhibitor

JSI-1187 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by JS InnoPharm, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 months
Awards & highlights

Study Summary

This trial is testing a new drug, JSI-1187, as a possible treatment for cancer. It will be tested alone and in combination with another drug, dabrafenib. The study is for people with advanced solid tumors that have mutations in the MAPK pathway, which causes the pathway to be overactive.

Eligible Conditions
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a type of cancer that has spread to other parts of your body, and it can be measured. You are a suitable candidate for trying out new treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 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
Incidence of treatment emergent adverse events (safety and tolerability)
Secondary outcome measures
Disease Control Rate
Duration of Response
Objective Response Rate
+3 more
Other outcome measures
Neoplasms
Mean plasma concentrations of JSI-1187 alone and in combination with dabrafenib
pRSK/RSK ratio in whole blood (PBMCs) (pharmacodynamic endpoint)

Side effects data

From 2016 Phase 3 trial • 251 Patients • NCT01227889
40%
Arthralgia
38%
Hyperkeratosis
36%
Headache
33%
Pyrexia
29%
Nausea
29%
Alopecia
26%
Fatigue
26%
Skin papilloma
22%
Back pain
22%
Vomiting
20%
Asthenia
20%
Palmar-plantar erythrodysaesthesia syndrome
19%
Rash
19%
Nasopharyngitis
18%
Cough
17%
Diarrhoea
17%
Myalgia
17%
Pain in extremity
15%
Dry skin
14%
Constipation
14%
Decreased appetite
12%
Chills
12%
Seborrhoeic keratosis
12%
Dyspnoea
12%
Actinic keratosis
10%
Musculoskeletal pain
10%
Erythema
9%
Insomnia
9%
Palmoplantar keratoderma
8%
Abdominal pain
8%
Dizziness
8%
Papilloma
7%
Influenza like illness
7%
Weight decreased
7%
Hyperglycaemia
7%
Hair texture abnormal
7%
Skin lesion
6%
Pruritus
6%
Hypophosphataemia
6%
Abdominal pain upper
6%
Folliculitis
6%
Upper respiratory tract infection
6%
Alanine aminotransferase increased
6%
Paraesthesia
6%
Acrochordon
6%
Melanocytic naevus
5%
Hypertension
5%
Aspartate aminotransferase increased
5%
Musculoskeletal chest pain
5%
Anxiety
5%
Eczema
5%
Oropharyngeal pain
5%
Anaemia
4%
Squamous cell carcinoma
4%
Squamous cell carcinoma of skin
3%
Basal cell carcinoma
2%
Ejection fraction decreased
2%
Malignant melanoma
2%
Malignant melanoma in situ
2%
Atrial fibrillation
1%
Blood creatine phosphokinase increased
1%
Focal nodular hyperplasia
1%
Breast cancer
1%
Pancreatitis acute
1%
Lip squamous cell carcinoma
1%
Blood creatinine increased
1%
Ileus
1%
Cellulitis
1%
Anal abscess
1%
Erysipelas
1%
Papillary thyroid cancer
1%
Cataract
1%
Febrile neutropenia
1%
Lymphadenopathy
1%
Acute coronary syndrome
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Myocardial ischaemia
1%
Colitis
1%
Haemorrhoidal haemorrhage
1%
Large intestine perforation
1%
Pancreatic necrosis
1%
Small intestinal perforation
1%
Euthanasia
1%
Abdominal infection
1%
Localised infection
1%
Perineal abscess
1%
Pleural infection
1%
Pneumonia
1%
Head injury
1%
Radius fracture
1%
Blood bilirubin increased
1%
Dehydration
1%
Diabetes mellitus
1%
Diabetes mellitus inadequate control
1%
Hyperlipasaemia
1%
Hyponatraemia
1%
Osteoporotic fracture
1%
Parkinsonism
1%
Presyncope
1%
Syncope
1%
Psychotic disorder
1%
Renal failure
1%
Urinary bladder polyp
1%
Hypoxia
1%
Pleural effusion
1%
Pulmonary embolism
1%
Pulmonary oedema
1%
Respiratory distress
1%
Dermal cyst
1%
Hypotension
1%
Acute myocardial infarction
1%
Pancreatitis
1%
Gait disturbance
1%
Pleuritic pain
1%
Hepatitis E
1%
Hepatic pain
1%
Joint effusion
1%
Muscular weakness
1%
Acoustic neuroma
1%
Adenocarcinoma of the cervix
1%
Transient ischaemic attack
1%
Haematoma
1%
Haemorrhage
1%
Bowen's disease
1%
Soft tissue sarcoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK2118436 150 mg BID
DTIC 1000 mg/m^2 in RP
GSK25118436 in the Crossover Phase

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: JSI-1187 Plus Dabrafenib ExpansionExperimental Treatment2 Interventions
Cohort 1: BRAF V600E/K-mutated unresectable or metastatic melanoma after 1-3 prior therapies for metastatic disease, including anti-PD1 therapy, with or without ipilimumab, and BRAF/MEK inhibitor treatment. Cohort 2: BRAF V600E/K-mutated unresectable or metastatic melanoma after BRAF/MEK inhibitor adjuvant therapy for Stage 3 disease followed by 1-2 prior therapies for metastatic disease, including anti-PD-1 therapy, with or without ipilimumab, and excluding BRAF/MEK inhibitor treatment. Cohort 3: BRAF V600E-mutated metastatic NSCLC after 1-2 prior therapies for metastatic disease.
Group II: Part B: JSI-1187 Plus Dabrafenib Combination Dose EscalationExperimental Treatment2 Interventions
BRAF V600E/K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated NSCLC, or BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer, or other BRAF V600E-mutated unresectable or metastatic solid tumors
Group III: Part A: JSI-1187 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Locally advanced or metastatic solid tumors with confirmed with MAPK pathway mutation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120

Find a Location

Who is running the clinical trial?

JS InnoPharm, LLCLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

JSI-1187 (MAPK Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04418167 — Phase 1
Solid Tumors Research Study Groups: Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation, Part C: JSI-1187 Plus Dabrafenib Expansion, Part A: JSI-1187 Monotherapy Dose Escalation
Solid Tumors Clinical Trial 2023: JSI-1187 Highlights & Side Effects. Trial Name: NCT04418167 — Phase 1
JSI-1187 (MAPK Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04418167 — Phase 1

Frequently Asked Questions

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

Have any other experiments utilized JSI-1187 as a component?

"The University of Chicago Medical Center first researched JSI-1187 in 2012 and 42 trials have been concluded since then. At present, there are 46 studies actively enrolling patients; a large portion of which is taking place at Tucson's medical research facilities."

Answered by AI

How many centers are administrating this investigation?

"Currently, this clinical trial is being conducted out of 8 facilities. These locations are found in Tucson, Jacksonville and Phoenix as well as 5 other urban centres. To reduce any necessary travel commitments, it would be advisable to select the closest available site."

Answered by AI

How many participants are being recruited for this medical experiment?

"To complete this investigation, JS InnoPharm LLC must recruit 124 participants that satisfy the study's criteria. The trial will be conducted in multiple locations, such as Dana Farber Cancer Institute of Tucson and University of Arizona Comprehensive Cancer Centre from Jacksonville."

Answered by AI

Is participation in this experiment still open to new recruits?

"Data on clinicaltrials.gov demonstrates that recruitment for this trial is still ongoing, with the initial posting made on June 18th 2020 and edited as recently as September 1st 2022."

Answered by AI

What potential hazards should individuals be aware of when using JSI-1187?

"Due to the limited data on JSI-1187, our internal rating of its safety falls at a 1. This is because this trial has only reached Phase 1 and there is not yet enough evidence supporting both efficacy and security."

Answered by AI
~3 spots leftby Jun 2024