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

March 3, 2026 updated by: Salubris Biotherapeutics Inc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

255

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Escalating repeated doses of JK06 administered intravenously. A cycle of treatment is defined as 21 days.
Drug: JK06
Biparatopic anti-5T4 antibody
Experimental: Dose Expansion
The RP2D/OBD of JK06 determined by the Escalation arm. A cycle of treatment is defined as 21 days.
Drug: JK06
Biparatopic anti-5T4 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting Toxicity (DLT)
Time Frame: First 21 days of treatment.
The incidence of DLTs during the DLT assessment period.
First 21 days of treatment.
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.
From First Patient Dosed to end of Escalation, up to 14 months.
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.
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]
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].
Screening date through 28 days after last dose of treatment or End of Treatment [EOT] visit, whichever is later.
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.
From date of randomization until the date of first documented progression, assessed up to 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of JK06
Time Frame: Day 1 of dosing through 7 days post last dose.
Maximum Plasma Concentration (Cmax)
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.
Area Under the Curve (AUC)
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.
Lab draws at protocol defined intervals to measure Immunogenicity of circulating anti drug antibodies (ADA)
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
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.
"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
DOR according to RECIST v1.1.
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.
The percentage of patients with a confirmed CR, confirmed PR or SD for at least 2 consecutive tumor assessments
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salubris Biotherapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JK06.1.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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