Trial Title:
Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer
NCT ID:
NCT06667960
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Dose Escalation phase will use a 3+3 design with enrollment of 3 patients per cohort and
expansion to 6 patients in the event of a DLT. The Dose Escalation phase will determine
the MTD/recommended phase 2 dose (RP2D) for Cohort Expansion.
In the Cohort Expansion phase of the study, up to 3 parallel cohorts of patients with
specific tumor types, and a cohort of mixed solid tumors will simultaneously enroll and
be treated to further characterize the safety, tolerability, PK, pharmacodynamics, and
anti-tumor activity of JK06
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JK06
Description:
Biparatopic anti-5T4 antibody
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
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.
Detailed description:
This Phase 1/2, open label, dose escalation and cohort expansion study is designed to
evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity,
and preliminary anti-tumor activity of JK06 administered intravenously (IV) in patients
with unresectable, locally advanced, or metastatic cancer. The study consists of a Dose
Escalation phase to determine the MTD/recommended phase 2 dose (RP2D) of JK06, followed
by a Cohort Expansion phase to further define the safety and initial efficacy of JK06 in
tumor specific cohorts.
Criteria for eligibility:
Criteria:
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. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 5. Life
expectancy ≥ 12 weeks. 6. 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.
7. 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. 8. Identification
of an archival tumor sample (i.e., tissue block (formalin-fixed
paraffin-embedded [FFPE]) or a series of approximately 10-15 slides).
9. 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.
10. 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.
11. Treated central nervous system (CNS) metastases 12. Must be willing and
able to comply with clinic visits and procedures outlined in the study
protocol.
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitair Ziekenhuis Antwerpen
Address:
City:
Antwerp
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Ann Decoene
Phone:
+ 32 3 821 47 19
Email:
oncotrials@uza.be
Investigator:
Last name:
Hans Prenen, MD
Email:
Principal Investigator
Facility:
Name:
Institut Jules Bordet
Address:
City:
Bruxelles
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Michele Schroeder
Phone:
+32 (0) 2 541 38 33
Email:
michele.schroeder@hubruxelles.be
Investigator:
Last name:
Nuria Kotecki, MD
Email:
Principal Investigator
Facility:
Name:
UZ Ghent
Address:
City:
Ghent
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Celine Mortier
Phone:
+32 9 332 00 04
Email:
celine.mortier1@uzgent.be
Investigator:
Last name:
Sylvie Rottey, MD
Email:
Principal Investigator
Facility:
Name:
CHU UCL Namur - site Godinne
Address:
City:
Yvoir
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Mathilde Parmentier
Phone:
+32 (0)81 42 38 57
Email:
mathilde.parmentier@chuuclnamur.uclouvain.be
Investigator:
Last name:
Lionel D'Hondt, MD
Email:
Principal Investigator
Start date:
October 23, 2024
Completion date:
August 1, 2028
Lead sponsor:
Agency:
Salubris Biotherapeutics Inc
Agency class:
Industry
Source:
Salubris Biotherapeutics Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06667960
