Solid TumorPhase 1/2NCT06667960
Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer
A Phase 1/2 study testing JK06 in people with Solid Tumor, run by Salubris Biotherapeutics Inc at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- JK06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 23 Oct 2024to 1 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old.
- Signed informed consent and willing and able to comply with study procedures and scheduled visits.
- For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
- Dose expansion solid tumor groups.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Life expectancy ≥ 12 weeks.
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- 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.
- 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.
- Identification of an archival tumor sample (i.e., tissue block (formalin-fixed paraffin-embedded [FFPE]) or a series of approximately 10-15 slides).
- 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.
- 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.
- 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.
- Central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet certain criteria at the time of enrollment.
- Must be willing and able to comply with clinic visits and procedures outlined in the study protocol.
- 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.
Who cannot join
- 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.
- Major surgery within 6 weeks from treatment initiation.
- Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.
- Clinically significant gastrointestinal disorders.
- Clinically significant pulmonary compromise requiring supplemental oxygen use.
- Grade 2 or greater peripheral neuropathy at time of study entry.
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- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
- Known hypersensitivity to JK06 or any excipient.
- 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.
- 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.
- Recent or ongoing serious infection.
- 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.
- Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4 weeks of treatment initiation.
- Pregnant or nursing.
- Therapeutic anticoagulation for a thromboembolic event that occurred within 3 months of dosing; prophylactic anticoagulation is permitted.
- 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.
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
Spain10 sites, 10 recruiting
- Recruiting
NEXT Oncology Barcelona
Barcelona
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
START Barcelona
Barcelona
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
Vall d Hebron Institute of Oncology VHIO
Barcelona
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
CUN Madrid
Madrid, 28027
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
October 12th Hospital
Madrid, 28041
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
Next Oncology Madrid
Madrid
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
START Madrid
Madrid
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
CUN Pamplona
Pamplona, 31008
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
START Rioja
Rioja, 26006
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
Instituto de Investigación Sanitaria INCLIVA
Valencia, 46010
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
Belgium4 sites, 4 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
Institut Jules Bordet
Brussels
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
UZ Ghent
Ghent
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
- Recruiting
CHU UCL Namur - site Godinne
Yvoir
Jennifer Lindelien, +1-888-521-8961, jennifer.lindelien@salubrisbio.com
About this study
Official title: A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients With Unresectable Locally Advanced or Metastatic Cancer
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.
Read the detailed description
This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, 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.
- Conditions
- Solid Tumor
- Being tested
- JK06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK06Drug
Biparatopic anti-5T4 antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Escalating repeated doses of JK06 administered intravenously. A cycle of treatment is defined as 21 days. Receives: Drug: JK06 |
| Dose Expansion | Experimental | The RP2D/OBD of JK06 determined by the Escalation arm. A cycle of treatment is defined as 21 days. Receives: Drug: JK06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
The incidence of DLTs during the DLT assessment period.
Measured: First 21 days of treatment.
Dose-Finding
Determination of the maximum-tolerated dose/recommended Phase 2 dose.
Measured: From First Patient Dosed to end of Escalation, up to 14 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Measured: First treatment through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of Serious Adverse Events [SAEs].
Measured: Screening date through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Measured: From date of randomization until the date of first documented progression, assessed up to 104 weeks
Secondary outcomes (6)
Pharmacokinetics of JK06
Maximum Plasma Concentration (Cmax)
Measured: Day 1 of dosing through 7 days post last dose.
Pharmacokinetics of JK06
Area Under the Curve (AUC)
Measured: Day 1 of dosing through 7 days post last dose.
Immunogenicity of JK06 by blood level measurement
Lab draws at protocol defined intervals to measure Immunogenicity of circulating anti drug antibodies (ADA)
Measured: Day 1 of dosing through 7 days post last dose.
Progression Free Survival (PFS)
Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.
Measured: "From date of randomization until the date of first documented progression, assessed up to 104 weeks
Duration of Response (DOR)
DOR according to RECIST v1.1.
Measured: From date of randomization until the date of first documented progression, assessed up to 104 weeks
Disease Control Rate (DCR)
The percentage of patients with a confirmed CR, confirmed PR or SD for at least 2 consecutive tumor assessments
Measured: Time of initial response (CR or PR) documentation (in patients who have a subsequent confirmation of objective response) to the time of confirmed progressive disease using RECIST 1.1, or death, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start23 Oct 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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, 2 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, and anti-tumor activity of JK06
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salubris Biotherapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667960
- Sponsor's protocol ID
- JK06.1.01
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients With Unresectable Locally Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT06667960
- Acronym / sponsor ID
- JK06.1.01
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Salubris Biotherapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 Oct 2024 (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 1/2, 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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, 2 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, and anti-tumor activity of JK06
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JK06Escalating repeated doses of JK06 administered intravenously. A cycle of treatment is defined as 21 days. |
| Dose Expansion | Experimental | Drug: JK06The RP2D/OBD of JK06 determined by the Escalation arm. A cycle of treatment is defined as 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years old.
- Signed informed consent and willing and able to comply with study procedures and scheduled visits.
- For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
- Dose expansion solid tumor groups.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Key exclusion criteria (19 listed)
- 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.
- Major surgery within 6 weeks from treatment initiation.
- Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.
- Clinically significant gastrointestinal disorders.
- Clinically significant pulmonary compromise requiring supplemental oxygen use.
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 |
|---|---|---|
| JK06Biparatopic anti-5T4 antibody | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
Dose-Finding
Time frame: 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]
Time frame: 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]
Time frame: 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)
Time frame: From date of randomization until the date of first documented progression, assessed up to 104 weeks
ORR according to RECIST v1.1.
6 secondary outcomes
Pharmacokinetics of JK06
Time frame: Day 1 of dosing through 7 days post last dose.
Pharmacokinetics of JK06
Time frame: Day 1 of dosing through 7 days post last dose.
Immunogenicity of JK06 by blood level measurement
Time frame: Day 1 of dosing through 7 days post last dose.
Progression Free Survival (PFS)
Time frame: "From date of randomization until the date of first documented progression, assessed up to 104 weeks
Duration of Response (DOR)
Time frame: From date of randomization until the date of first documented progression, assessed up to 104 weeks
Disease Control Rate (DCR)
Time frame: Time of initial response (CR or PR) documentation (in patients who have a subsequent confirmation of objective response) to the time of confirmed progressive disease using RECIST 1.1, or death, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JK06 in people with Solid Tumor, run by Salubris Biotherapeutics Inc at 14 sites in 2 countries.
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 24 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Belgium. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naimish Pandya, MD (+1-888-521-8961, naimish.pandya@salubrisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: First 21 days of treatment.). The study lists 5 primary outcomes in all. 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 5 Mar 2026.