Ireland
--:--IST
Recruiting Phase 1/2

Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer

NCT06667960 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2024-10-23
Last updated
2026-03-05

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

JK06

JK06: Biparatopic anti-5T4 antibody

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Signed informed consent and willing and able to comply with study procedures and scheduled visits. 3. For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors. 4. Dose expansion solid tumor groups. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 6. Life expectancy ≥ 12 weeks. 7. Measurable disease as per RECIST 1.1 criteria and documented by CT and/or MRI. Note: lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment. 8. Acceptable laboratory parameters: * Albumin ≥ 2.8 g/dL. * Platelet count ≥ 100, 000. * Hemoglobin ≥ 9.0 g/dL. * Absolute neutrophil count ≥ 1,500/μL. * ALT/AST ≤ 3.0 times ULN. \- ALT/AST ≤ 5 × ULN for patients with liver metastases. * Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease. * Direct bilirubin ≤ 1.5 ULN for patients with total bilirubin \> 1.5 ULN. * Creatinine ≤ 1.8 mg/dL. -Or calculated/measured creatinine clearance \> 30 mL/minute. 9. Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded \[FFPE\]) or a series of approximately 10-15 slides). 10. Consent to pre-treatment fresh tumor biopsy for patients enrolled in the back-fill part of Dose Escalation and all eligible patients enrolled in Cohort Expansion. 11. Women of childbearing potential (WOCBP) not surgically sterilized and between menarche and 1 year post menopause must have a negative serum or urine pregnancy test and be willing to use 2 forms of effective contraception throughout the study starting with screening through 217 days after the last dose of JK06. 12. Male patients with partners of childbearing potential, even if surgically sterilized (i.e., status post-vasectomy) must agree to contraceptive use from the time of consent through 217 days after treatment discontinuation. 13. Central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet certain criteria at the time of enrollment. 14. Must be willing and able to comply with clinic visits and procedures outlined in the study protocol. 15. Concurrent use of hormones for breast cancer or for non-cancer related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates or RANK-L inhibitors or analogues are permitted for supportive care of patients with bone metastases. Exclusion Criteria: 1. Patients with symptomatic or unstable CNS primary tumor or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the investigator. 2. Major surgery within 6 weeks from treatment initiation. 3. Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose. 4. Clinically significant gastrointestinal disorders. 5. Clinically significant pulmonary compromise requiring supplemental oxygen use. 6. Grade 2 or greater peripheral neuropathy at time of study entry. 7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. 8. Known hypersensitivity to JK06 or any excipient. 9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, or any malignancy considered to be indolent and never required therapy. 10. Any serious underlying medical or psychiatric condition that would preclude understanding and rendering of informed consent or impair the ability of the patient to receive or tolerate the planned treatment. 11. Recent or ongoing serious infection. 12. Prior systemic anti-cancer treatment: * For cytotoxic chemotherapy, small molecule inhibitors, radiation, or similar investigational treatments, ≤ 2 weeks or 5 half-lives, whichever is shorter. * For monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter. * Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter. 13. Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4 weeks of treatment initiation. 14. Pregnant or nursing. 15. Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing; prophylactic anticoagulation is permitted. 16. Active pneumonitis/interstitial lung disease (ILD) or history of drug-induced or radiation-induced pneumonitis/ILD that requires ongoing systemic corticosteroid treatment or has not fully resolved at study entry.

Primary outcome measure(s)

  • Dose-limiting Toxicity (DLT) — First 21 days of treatment.
    The incidence of DLTs during the DLT assessment period.
  • Dose-Finding — From First Patient Dosed to end of Escalation, up to 14 months.
    Determination of the maximum-tolerated dose/recommended Phase 2 dose.
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
    Incidence, nature, and severity of treatment-emergent adverse events \[TEAEs\]. Defined as any AE that occurs during the treatment period (i.e., after any treatment) and up to 28 days after the last dose of study treatment.
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — Screening date through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
    Incidence, nature, and severity of Serious Adverse Events \[SAEs\].
  • Objective Response Rate (ORR) — From date of randomization until the date of first documented progression, assessed up to 104 weeks
    ORR according to RECIST v1.1.

Trial sites (14)

FacilityCityRegionStatus
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
UZ Ghent Ghent Belgium Recruiting
CHU UCL Namur - site Godinne Yvoir Belgium Recruiting
NEXT Oncology Barcelona Barcelona Spain Recruiting
START Barcelona Barcelona Spain Recruiting
Vall d Hebron Institute of Oncology VHIO Barcelona Spain Recruiting
CUN Madrid Madrid Spain Recruiting
October 12th Hospital Madrid Spain Recruiting
Next Oncology Madrid Madrid Spain Recruiting
START Madrid Madrid Spain Recruiting
CUN Pamplona Pamplona Spain Recruiting
START Rioja Rioja Spain Recruiting
Instituto de Investigación Sanitaria INCLIVA Valencia Spain Recruiting

More Salubris Biotherapeutics Inc trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667960 on ClinicalTrials.gov ↗ ← All trials in Spain