JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
JS InnoPharm, LLC
Study ID
NCT04418167
Phase
PHASE1
Status
Suspended

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JSI-1187 — DRUG
    JSI-1187 capsules for oral administration
  • Dabrafenib — DRUG
    Dabrafenib capsules for oral administration

Study Details

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.

Key Dates

Start date
Jun 18, 2020
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
71 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: JSI-1187 Monotherapy Dose Escalation
    Locally advanced or metastatic solid tumors with confirmed with MAPK pathway mutation
  • Experimental: Part B: JSI-1187 Plus Dabrafenib Combination Dose Escalation
    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
  • Experimental: Part C: JSI-1187 Plus Dabrafenib Expansion
    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.

Primary Outcome Measure

Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: 35 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterPhoenixArizona85054-
University of Arizona Comprehensive Cancer CenterTucsonArizona85724-
University of California Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Mayo Clinic Cancer CenterJacksonvilleFlorida32224-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Cancer Center· Phoenix, AZUniversity of Arizona Comprehensive Cancer Center· Tucson, AZUniversity of California Helen Diller Family Comprehensive Cancer Center· San Francisco, CAMayo Clinic Cancer Center· Jacksonville, FLDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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