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

NCT06667960 | Recruiting Phase 1 DMC

• 1 other identifier: JK06.1.01
• Study Type: interventional
• Target: 255
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (5)

• Dose-limiting Toxicity (DLT)

  The incidence of DLTs during the DLT assessment period.

  First 21 days of treatment.

• Dose-Finding

  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]

  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]

  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)

  ORR according to RECIST v1.1.

  From date of randomization until the date of first documented progression, assessed up to 104 weeks

Secondary Outcomes (6)

• Pharmacokinetics of JK06

  Day 1 of dosing through 7 days post last dose.

• Pharmacokinetics of JK06

  Day 1 of dosing through 7 days post last dose.

• Immunogenicity of JK06 by blood level measurement

  Day 1 of dosing through 7 days post last dose.

• Progression Free Survival (PFS)

  "From date of randomization until the date of first documented progression, assessed up to 104 weeks

• Duration of Response (DOR)

  From date of randomization until the date of first documented progression, assessed up to 104 weeks

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Escalating repeated doses of JK06 administered intravenously. A cycle of treatment is defined as 21 days.

Drug: JK06

Dose Expansion

EXPERIMENTAL

The RP2D/OBD of JK06 determined by the Escalation arm. A cycle of treatment is defined as 21 days.

Drug: JK06

Interventions

JK06 DRUG

Biparatopic anti-5T4 antibody

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Salubris Biotherapeutics Inc: lead

Study Sites (14)

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, 28027, Spain

RECRUITING

October 12th Hospital

Madrid, 28041, Spain

RECRUITING

Next Oncology Madrid

Madrid, Spain

RECRUITING

START Madrid

Madrid, Spain

RECRUITING

CUN Pamplona

Pamplona, 31008, Spain

RECRUITING

START Rioja

Rioja, 26006, Spain

RECRUITING

Instituto de Investigación Sanitaria INCLIVA

Valencia, 46010, Spain

RECRUITING

Central Study Contacts

Naimish Pandya, MD

CONTACT

+1-888-521-8961; naimish.pandya@salubrisbio.com

Jennifer Lindelien

CONTACT

+1-888-521-8961; jennifer.lindelien@salubrisbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 31, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10); BE (4)