Solid TumorsPhase 1NCT04418167
JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations
A Phase 1 study testing JSI-1187 and Dabrafenib in people with Solid Tumors, run by JS InnoPharm, LLC at 7 sites in United States.
Trial summary
This is a Phase 1 study of JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- JSI-1187 and Dabrafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Jun 2020to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age
- Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy
- Part A (JSI-1187 Monotherapy Dose Escalation): Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions, e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit
- (On hold, effective 05 July 2023) Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation): Histologically or cytologically confirmed BRAF V600E/K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic NSCLC, BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer, or other BRAF V600E-mutated unresectable or metastatic solid tumors, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit
- (On hold, effective 05 July 2023) Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
- 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
Show all 23Show fewer
- 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 or 2 prior therapies for metastatic disease
- MAPK mutation tumor status will be established prior to entry based on previous MAPK pathway mutation reports from a CLIA qualified laboratory, or, if a report is not available, the mutation analysis will be performed at Screening on archival tissue or newly biopsied tumor tissue.
- Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior cancer treatment, surgery, or radiotherapy to Grade ≤ 1. Subjects with prior immune checkpoint inhibitor endocrinopathies must have resolution to ≤ Grade 2 and be stable on hormonal therapy (e.g., levothyroxine, hydrocortisone, insulin, etc.).
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Life expectancy of ≥ 3 months
- Subjects with asymptomatic stable, prior or currently treated brain metastases are allowed
- Adequate hematologic parameters without ongoing transfusional support:
- Hemoglobin (Hb) ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 cells/L
- Platelets ≥ 75 x 10^9 cells/L
- Adequate renal and hepatic function:
- Creatinine ≤ 1.5 times the upper limit of normal (ULN), or calculated creatinine clearance ≥ 50 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 times the (ULN) unless due to Gilbert's disease
- ALT/AST ≤ 2 times the ULN, or < 3 times the ULN for subjects with liver metastases
- Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy throughout the study and for 28 days after the completion of study treatment.
- Ability to provide written informed consent
Who cannot join
- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
- QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation
- Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
- Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
- Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
- Medications that are strong inhibitors of BCRP are prohibited during study and for 14 days prior to the first dose of study drugs(s).
Show all 19Show fewer
- Subjects on dabrafenib (Parts B and C) also are advised to avoid concurrent administration of strong inhibitors of CYP2C8 as these medications may increase the concentration of dabrafenib
- History of or current evidence/risk of retinal vein occlusion or central serous retinopathy, or has medically relevant abnormalities identified on screening ophthalmologic examination
- Symptomatic central nervous system malignancy or metastasis
- Gastrointestinal conditions that could impair absorption of study drug(s)
- Current hematologic malignancies
- Second, active primary solid tumor malignancy that, in the judgement of the investigator or Sponsor medical monitor, may affect the interpretation of results
- Prior malignancies, with the exception of carcinoma in situ of any origin, non-muscle invasive bladder cancer, Gleason 3+3 prostate cancer and prior malignancies in remission whose likelihood of recurrence is very low, as judged by the Sponsor medical monitor.
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment within the last week prior to study treatment
- Other active infection requiring IV antibiotic usage within the last week prior to study treatment
- Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
- Receipt of an investigational product on a clinical trial within 5 elimination half-lives or within 28 days, whichever is shorter, prior to C1D1 on this study, or currently enrolled in a clinical trial, involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Previously completed or withdrawn from this study or any other study investigating an ERK1/2 inhibitor.
- If female, pregnant, breast-feeding, or planning to become pregnant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of California Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations
This is a Phase 1 study of JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
Read the detailed description
Selected subjects will include males and females age ≥18 years; histologically confirmed locally advanced or metastatic solid tumors with archived tumor sample from the primary, recurrent or metastatic disease with documented MAPK pathway mutation or pathway hyperactivating mutations; advanced or recovered from all acute toxicities (≤ Grade 1) due to prior therapy; adequate renal and hepatic function; and no known history of significant cardiac or retinal disease.
Part A (Monotherapy Dose Escalation): Following screening, a total of up to 80 subjects are anticipated to establish the MTD of JSI-1187 monotherapy in subjects with locally advanced or metastatic solid tumors with MAPK pathway mutations, including hyperactivating pathway mutations or gene fusions, refractory to or relapsed on prior therapy. JSI-1187 will be administered orally at doses of 2, 4 and 8 mg twice daily, and at doses of 16, 24, 36, 56, 88 and 128 mg once or twice daily, or until an MTD for both regimens is reached, whichever is earlier, repeated every 28 days (=1 cycle). A 3+3 dose escalation schema will be followed to establish the MTD of the JSI-1187 monotherapy. Subjects will take their doses in a fasted state, 1 hour before or 2 hours after a meal. A total of 6 subjects will be treatment at the MTD before starting Part B.
(On hold, effective 05 July 2023) Part B (Combination Dose Escalation): Following screening, a total of up to 36 subjects are anticipated to establish the MTD of JSI-1187 plus dabrafenib in BRAF V600E/K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer, or other BRAF V600E-mutated unresectable or metastatic solid tumors. A 3+3 dose escalation schema will be followed to establish the MTD of the JSI-1187 plus dabrafenib combination. Daily doses of both drugs will be taken in the fasted state. A total of 6 subjects will be treated at the JSI-1187 plus dabrafenib combined MTD before beginning Part C.
(On hold, effective 05 July 2023) Part C (Expansion Cohorts): Following screening, a total of 58 subjects in 3 cohorts are anticipated to expand the disease treatment settings of JSI-1187 in combination with dabrafenib in BRAF V600E/K-mutated melanoma or BRAF V600E-mutated NSCLC.
Cohort 1: JSI-1187 plus dabrafenib in 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. (n=21).
Cohort 2: JSI-1187 plus dabrafenib in 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. (n=21).
Cohort 3: JSI-1187 plus dabrafenib in BRAF V600E-mutated metastatic NSCLC after 1-2 prior therapies for metastatic disease. (n=16).
JSI-1187 plus dabrafenib will be administered at the MTDs established for both drugs in Part B, repeated every 28 days (=1 cycle).
Subjects who demonstrate clinical benefit (CR, PR or SD) will be allowed to continue therapy with JSI-1187 (and dabrafenib) until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Disease response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1).
Blood for hematology, coagulation parameters and serum chemistry determinations will be collected, ECGs will be taken, and ophthalmologic exams will be conducted during the study.
Blood will be collected for PK assessment of JSI-1187 and PD assessment of pRSK/RSK ratio determinations.
Tumor biopsies (optional) will be collected from consenting subjects at Screening and on-study for pRSK determination. Results will be correlated with clinical outcome.
- Conditions
- Solid Tumors
- Being tested
- JSI-1187, Dabrafenib
- Keywords
- solid tumor, neoplasm, BRAF V600 mutation, MAPK pathway mutation, ERK1/2, JSI-1187, Dabrafenib, KRAS, NRAS, BRAF, melanoma, non-small cell lung cancer, anaplastic thyroid cancer
- Medical subject headings
- Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSI-1187Drug
JSI-1187 capsules for oral administration
DabrafenibDrug
Also called TAFINLAR
Dabrafenib capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part A: JSI-1187 Monotherapy Dose Escalation | Experimental | Locally advanced or metastatic solid tumors with confirmed with MAPK pathway mutation Receives: Drug: JSI-1187 |
| Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation | Experimental | 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 Receives: Drug: JSI-1187; Drug: Dabrafenib |
| Part C: JSI-1187 Plus Dabrafenib Expansion | Experimental | 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. Receives: Drug: JSI-1187; Drug: Dabrafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (safety and tolerability)
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
Measured: 35 months
Secondary outcomes (6)
Objective Response Rate
Proportion of subjects with objective responses (complete response [CR] + partial response [PR]) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following last dose of study drug (each cycle is 28 days)
Duration of Response
Length of time from first evidence of objective response (CR, PR) to the first objective evidence of disease progression
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Time to Response
Length of time from the date of first dose of study drug to the first evidence of objective response (CR, PR)
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Disease Control Rate
Proportion of subjects with best response of CR, PR or stable disease (SD)
Measured: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Progression-Free Survival
Length of time from the date of first dose of study drug to the first evidence of disease progression or death, whichever is earlier
Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier, assessed up to 35 months
Overall Survival
Length of time from the date of first dose of study drug to date of death from any cause
Measured: Assessed from the date of the first dose of study drug to date of death from any cause, assessed up to 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start18 Jun 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Sequential
- Model description
- A total of up to 80 subjects are anticipated in the JSI-1187 monotherapy dose-escalation phase (Part A). A total of up to 36 subjects are anticipated in the JSI-1187 plus dabrafenib dose-escalation phase (Part B). A total of 58 subjects are anticipated in the JSI-1187 plus dabrafenib expansion phase
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- JS InnoPharm, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418167
- Sponsor's protocol ID
- JSI-1187-01
- Status last verified
- Aug 2025
- First submitted
- 11 May 2020
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations
- ClinicalTrials.gov ID
- NCT04418167
- Acronym / sponsor ID
- JSI-1187-01
- Conditions
- Solid Tumors
- Keywords
- solid tumor, neoplasm, BRAF V600 mutation, MAPK pathway mutation, ERK1/2, JSI-1187, Dabrafenib, KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor decision
- Enrolment
- 71 participants (actual)
- Lead sponsor
- JS InnoPharm, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 2020 (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.
This is a Phase 1 study of JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.
Detailed description
Selected subjects will include males and females age ≥18 years; histologically confirmed locally advanced or metastatic solid tumors with archived tumor sample from the primary, recurrent or metastatic disease with documented MAPK pathway mutation or pathway hyperactivating mutations; advanced or recovered from all acute toxicities (≤ Grade 1) due to prior therapy; adequate renal and hepatic function; and no known history of significant cardiac or retinal disease.
Part A (Monotherapy Dose Escalation): Following screening, a total of up to 80 subjects are anticipated to establish the MTD of JSI-1187 monotherapy in subjects with locally advanced or metastatic solid tumors with MAPK pathway mutations, including hyperactivating pathway mutations or gene fusions, refractory to or relapsed on prior therapy. JSI-1187 will be administered orally at doses of 2, 4 and 8 mg twice daily, and at doses of 16, 24, 36, 56, 88 and 128 mg once or twice daily, or until an MTD for both regimens is reached, whichever is earlier, repeated every 28 days (=1 cycle). A 3+3 dose escalation schema will be followed to establish the MTD of the JSI-1187 monotherapy. Subjects will take their doses in a fasted state, 1 hour before or 2 hours after a meal. A total of 6 subjects will be treatment at the MTD before starting Part B.
(On hold, effective 05 July 2023) Part B (Combination Dose Escalation): Following screening, a total of up to 36 subjects are anticipated to establish the MTD of JSI-1187 plus dabrafenib in BRAF V600E/K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC), BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer, or other BRAF V600E-mutated unresectable or metastatic solid tumors. A 3+3 dose escalation schema will be followed to establish the MTD of the JSI-1187 plus dabrafenib combination. Daily doses of both drugs will be taken in the fasted state. A total of 6 subjects will be treated at the JSI-1187 plus dabrafenib combined MTD before beginning Part C.
(On hold, effective 05 July 2023) Part C (Expansion Cohorts): Following screening, a total of 58 subjects in 3 cohorts are anticipated to expand the disease treatment settings of JSI-1187 in combination with dabrafenib in BRAF V600E/K-mutated melanoma or BRAF V600E-mutated NSCLC.
Cohort 1: JSI-1187 plus dabrafenib in 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. (n=21).
Cohort 2: JSI-1187 plus dabrafenib in 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. (n=21).
Cohort 3: JSI-1187 plus dabrafenib in BRAF V600E-mutated metastatic NSCLC after 1-2 prior therapies for metastatic disease. (n=16).
JSI-1187 plus dabrafenib will be administered at the MTDs established for both drugs in Part B, repeated every 28 days (=1 cycle).
Subjects who demonstrate clinical benefit (CR, PR or SD) will be allowed to continue therapy with JSI-1187 (and dabrafenib) until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Disease response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1).
Blood for hematology, coagulation parameters and serum chemistry determinations will be collected, ECGs will be taken, and ophthalmologic exams will be conducted during the study.
Blood will be collected for PK assessment of JSI-1187 and PD assessment of pRSK/RSK ratio determinations.
Tumor biopsies (optional) will be collected from consenting subjects at Screening and on-study for pRSK determination. Results will be correlated with clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of up to 80 subjects are anticipated in the JSI-1187 monotherapy dose-escalation phase (Part A). A total of up to 36 subjects are anticipated in the JSI-1187 plus dabrafenib dose-escalation phase (Part B). A total of 58 subjects are anticipated in the JSI-1187 plus dabrafenib expansion phase
| Arm | Type | Receives |
|---|---|---|
| Part A: JSI-1187 Monotherapy Dose Escalation | Experimental | Drug: JSI-1187Locally advanced or metastatic solid tumors with confirmed with MAPK pathway mutation |
| Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation | Experimental | Drug: JSI-1187, Drug: DabrafenibBRAF 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 |
| Part C: JSI-1187 Plus Dabrafenib Expansion | Experimental | Drug: JSI-1187, Drug: DabrafenibCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Males and females ≥ 18 years of age
- Have locally advanced or metastatic solid tumor malignancy with measurable disease and be an appropriate candidate for experimental therapy
- Part A (JSI-1187 Monotherapy Dose Escalation): Histologically or cytologically confirmed MAPK pathway mutation, including hyperactivating pathway mutations or gene fusions, e.g., BRAF (Class I, II or III), RAS (H/K/N), MEK (MAP2K1), RAS-GAP (NF1 loss, RASA1), RAS-GEF, refractory to or relapsed on prior therapy, and have received all available therapy known to confer clinical benefit
- (On hold, effective 05 July 2023) Part B (JSI-1187 Plus Dabrafenib Combination Dose Escalation): Histologically or cytologically confirmed BRAF V600E/K-mutated unresectable or metastatic melanoma, BRAF V600E-mutated metastatic NSCLC, BRAF V600E-mutated locally advanced or metastatic anaplastic thyroid cancer, or other BRAF V600E-mutated unresectable or metastatic solid tumors, refractory to, or relapsed on, prior therapy, and have received all available therapy known to confer clinical benefit
- (On hold, effective 05 July 2023) Part C (JSI-1187 Plus Dabrafenib Expansion Cohorts): Histologically or cytologically confirmed:
Key exclusion criteria (19 listed)
- Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
- QT interval corrected for rate (QTc) > 480 msec on the ECG obtained at Screening using Fridericia method for QTc calculation
- Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care.
- Medications that are strong inhibitors of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
- Medications that are strong inducers of CYP3A4 are prohibited during study and for 14 days prior to the first dose of study drug(s).
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 |
|---|---|---|
| JSI-1187JSI-1187 capsules for oral administration | Drug | Part A: JSI-1187 Monotherapy Dose Escalation, Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation, Part C: JSI-1187 Plus Dabrafenib Expansion |
| DabrafenibAlso: TAFINLARDabrafenib capsules for oral administration | Drug | Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation, Part C: JSI-1187 Plus Dabrafenib Expansion |
Primary outcome
Incidence of treatment emergent adverse events (safety and tolerability)
Time frame: 35 months
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
6 secondary outcomes
Objective Response Rate
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following last dose of study drug (each cycle is 28 days)
Duration of Response
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Time to Response
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Disease Control Rate
Time frame: Assessed at the end of Cycle 2 and every 2 cycles thereafter through 6 months following the last dose of study drug (each cycle is 28 days)
Progression-Free Survival
Time frame: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier, assessed up to 35 months
Overall Survival
Time frame: Assessed from the date of the first dose of study drug to date of death from any cause, assessed up to 35 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
Active, not recruitingPhase 1
Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1/2
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Solid Tumors
Active, not recruitingPhase 2
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 JSI-1187 and Dabrafenib in people with Solid Tumors, run by JS InnoPharm, LLC at 7 sites in United States.
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 23 inclusion and 19 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: paused, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Results are not available in the source record.
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?
Incidence of treatment emergent adverse events (safety and tolerability) (time frame: 35 months). 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 3 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.