Actively Recruiting
Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Led by Salubris Biotherapeutics Inc · Updated on 2026-03-05
255
Participants Needed
14
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered JK06 in patients with unresectable locally, advanced or metastatic cancer.
CONDITIONS
Official Title
Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent and able to follow study procedures and visits
- Histologically confirmed unresectable, locally advanced, or metastatic solid tumors for dose escalation
- Enrollment in dose expansion solid tumor groups
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Measurable disease per RECIST 1.1 criteria confirmed by CT or MRI
- Previous radiation-treated lesions must show progression before enrollment
- Acceptable lab values: albumin ≥ 2.8 g/dL, platelet count ≥ 100,000, hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1,500/µL
- Liver enzymes ALT/AST ≤ 3 times upper limit normal (ULN) or ≤ 5 times ULN with liver metastases
- Total bilirubin ≤ 1.5 ULN or ≤ 3 ULN for Gilbert's disease
- Direct bilirubin ≤ 1.5 ULN if total bilirubin > 1.5 ULN
- Creatinine ≤ 1.8 mg/dL or creatinine clearance > 30 mL/min
- Availability of archival tumor tissue sample
- Consent to pre-treatment fresh tumor biopsy if enrolled in back-fill or cohort expansion
- Women of childbearing potential must have negative pregnancy test and agree to use two effective contraceptive methods during study and 217 days after last dose
- Male patients with partners of childbearing potential must agree to contraception during study and 217 days after treatment
- Treated and asymptomatic CNS metastases stable for at least 14 days
- Willingness and ability to comply with clinic visits and procedures
- Concurrent use of certain supportive medications allowed
You will not qualify if you...
- Symptomatic or unstable CNS tumors, metastases, or carcinomatous meningitis; treated CNS metastases must be stable at least 4 weeks
- Major surgery within 6 weeks before treatment
- Significant cardiovascular or vascular disease within 6 months before first dose
- Significant gastrointestinal disorders
- Pulmonary compromise requiring supplemental oxygen
- Peripheral neuropathy of grade 2 or higher at study entry
- Live virus vaccination within 4 weeks before study drug administration
- Known allergy to JK06 or its ingredients
- Second primary invasive cancer not in remission for at least 1 year except certain skin or in situ cancers
- Serious medical or psychiatric conditions preventing consent or treatment tolerance
- Recent or ongoing serious infection
- Recent systemic anti-cancer treatments within specified washout periods
- Ascites or pleural effusions requiring large volume drainage within 4 weeks
- Pregnancy or nursing
- Therapeutic anticoagulation for thromboembolism within 3 months before dosing
- Active or unresolved pneumonitis or interstitial lung disease requiring steroids or not fully resolved at entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Actively Recruiting
2
Institut Jules Bordet
Brussels, Belgium
Actively Recruiting
3
UZ Ghent
Ghent, Belgium
Actively Recruiting
4
CHU UCL Namur - site Godinne
Yvoir, Belgium
Actively Recruiting
5
NEXT Oncology Barcelona
Barcelona, Spain
Actively Recruiting
6
START Barcelona
Barcelona, Spain
Actively Recruiting
7
Vall d Hebron Institute of Oncology VHIO
Barcelona, Spain
Actively Recruiting
8
CUN Madrid
Madrid, Spain, 28027
Actively Recruiting
9
October 12th Hospital
Madrid, Spain, 28041
Actively Recruiting
10
Next Oncology Madrid
Madrid, Spain
Actively Recruiting
11
START Madrid
Madrid, Spain
Actively Recruiting
12
CUN Pamplona
Pamplona, Spain, 31008
Actively Recruiting
13
START Rioja
Rioja, Spain, 26006
Actively Recruiting
14
Instituto de Investigación Sanitaria INCLIVA
Valencia, Spain, 46010
Actively Recruiting
Research Team
N
Naimish Pandya, MD
CONTACT
J
Jennifer Lindelien
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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