A Phase 1/2, Multicenter, Open Label, Dose Escalation and Dose Expansion Study of JK06, a 5T4 Antibody Drug Conjugate, in Patients with Unresectable Locally Advanced or Metastatic Cancer

Phase 1

• Conditions: nresectable, Locally Advanced or Metastatic Cancer; MedDRA version: 21.1Level: PTClassification code: 10014720Term: Endometrial adenocarcinoma Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10001245Term: Adenosquamous cell lung cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10001150Term: Adenocarcinoma gastric Class: 100000004864; MedDRA version: 24.1Level: PTClassification code: 10085663Term: Clear cell papillary renal cell carcinoma Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10066354Term: Adenocarcinoma of the gastroesophageal junction Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10075333Term: Soft tissue sarcoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864

• Registration Number: CTIS2024-512421-92-00
• Lead Sponsor: Salubris Biotherapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Age = 18 years old., 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 performed within 72 hours prior to the initiation of study drug administration. • Be willing to use 2 forms of effective contraception throughout the study, starting with the screening and through 90 days after the last dose of JK06. - A comprehensive list of all highly effective birth control methods is included in Appendix 2. • Abstinence is considered a highly effective method if this is the established and preferred contraception method for the patient and is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female and male condoms should not be used together, Male patients with partners of childbearing potential, even if surgically sterilized (i.e., status post-vasectomy) must agree to: • Use effective barrier contraception from the time of consent through 90 days after discontinuation; or • Agree to practice true abstinence, if this is the established and preferred contraception method by the patient and is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. Periodic abstinence [e.g., calendar, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female and male condoms should not be used together. • In addition, male patients should also have their partners use contraception (as documented for female patients in Appendix 2) for the same period., Central nervous system (CNS) metastases must have been treated, be asymptomatic for = 14 days, and meet the following at the time of enrollment: • No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids = 10 mg prednisone/day or equivalent). • No concurrent or history of leptomeningeal disease or cord compression., 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., Signed informed consent and willing and able to comply with study procedures and scheduled visits., For Dose Escalation, patients with one of the following histologically diagnosed unresectable, locally advanced, or metastatic tumor types: • Non-small cell lung cancer (NSCLC) • Clear cell or papillary renal cell carcinoma (RCC). • Urothelial bladder cancer (UC). • Head and neck squamous cell cancer (HNSCC). • Breast cancer. • Gastric or gastroesophageal adenocarcinoma (GC/GEJ). • Epithelial ovarian cancer. • Cervical cancer. • Endometrial adenocarcinoma. •Prostate cancer. • Soft tissue sarcoma (except any liposarcoma or angiosarcoma). For the escalation cohorts, patients must have experienced pro

Exclusion Criteria

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., 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 including the following: • Any uncontrolled Grade 3 or higher (per CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of JK06. Routine antimicrobial prophylaxis is allowed. • Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy (HAART) therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required. • Known to be positive for hepatitis B (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Patients who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required. • Known active hepatitis C (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or having received antiviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required. • Known active or latent tuberculosis (testing at screening not required)., 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., Major surgery within 6 weeks from treatment initiation., Clinically significant cardiovascular/vascular disease = 6 months before first dose: • Myocardial infarction or unstable angina. • Clinically significant cardiac arrhythmias. • Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mmHg, diastolic blood pressure (DBP) > 100 mmHg. Pulmonary embolism, symptomatic cerebrovascular events or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). • QTcF prolongation > 480 msec. • Congestive heart failure (New York Heart Association class III-IV). • Myocarditis/clinically significant pericarditis., Clinically significant gastrointestinal disorders including: • Gastrointestinal perforation or unhealed ulcerations < 6 months prior to study drug administration. Patients must have documented evidence (e.g., upper endoscopy, colonoscopy) of completely healed area of prior perforation. • Clinically significant gastrointestinal bleeding < 3 months prior to study drug administration. • Pan

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified