JK06 / Shenzhen Salubris - LARVOL DELTA

A phase 1b / 2 study of JK06, a 5T4-targeted antibody drug conjugate, in patients with unresectable locally advanced or metastatic cancer (AACR 2026) - "Abstract is embargoed at this time."

ADC • Clinical • Metastases • P1 data • Oncology

JK06.1.01: Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=255 | Recruiting | Sponsor: Salubris Biotherapeutics Inc | N=155 ➔ 255

Enrollment change • First-in-human • Breast Cancer • Oncology • Solid Tumor

A phase 1/2 study of JK06, a 5T4 antibody drug conjugate, in patients with unresectable locally advanced or metastatic cancer. (ASCO 2025) - P1/2 | "Tumor specific expansion cohorts will be initiated once dose and schedule are established from dose escalation; fresh tumor biopsies will also be collected from patients enrolled in expansion cohorts. Response will be assessed every 9 weeks per RECIST v1.1."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TPBG

A phase I/II study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer (ESMO 2025) - P1/2 | "Conclusions To date, JK06 demonstrates promising clinical activity among several refractory solid tumors at multiple dose levels while being well tolerated without significant drug-related toxicities. Further dose evaluation and eventual expansion in tumor specific cohorts are planned"

Clinical • Metastases • P1/2 data • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • AVEN • EGFR • HER-2 • TPBG

Salubris Biotherapeutics Announces Dose Escalation Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the European Society for Medical Oncology 2025 Congress (Businesswire) - "5 confirmed partial responses (PRs) among 13 evaluable non-small cell lung cancer (NSCLC) patients (ORR 38%); 1 confirmed PR among 7 breast cancer patients. Favorable safety and PK profile, with encouraging activity, demonstrate a therapeutic window for JK06. Company proceeding with expansion cohorts in NSCLC and breast cancer."

P1/2 data • Trial status • Breast Cancer • Non Small Cell Lung Cancer

Development and preclinical evaluation of JK06, a biparatopic ADC against 5T4 (AACR 2025) - "Toxicokinetic evaluation showed a half-life which projects sustained exposure in humans with a Q3W dosing regimen. JK06 is currently being evaluated in an open-label, dose-escalation and expansion Phase I study to assess the safety, pharmacokinetics, and preliminary efficacy in a basket of solid tumors known to express 5T4."

Preclinical • Breast Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Solid Tumor • TPBG

A Study of JK06 in Patients with Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=155 | Recruiting | Sponsor: Salubris Biotherapeutics Inc

Metastases • New P1/2 trial • Oncology • Solid Tumor

Salubris Biotherapeutics Announces European Medicines Agency Approval to Initiate a Phase 1 Clinical Trial of JK06, a 5T4-Targeted ADC, in Solid Tumors (Businesswire) - "Salubris Biotherapeutics...announced it has received approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of JK06 in a basket of solid tumors known to express 5T4....JK06 will be evaluated in an open-label, dose-escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of JK06. Phase 1 recruitment is expected to commence in Q3 2024, with up to 155 subjects planned for enrollment."

New P1 trial • Solid Tumor

Salubris Biotherapeutics Announces $35 Million in Financing and Provides Pipeline Progress Update (Businesswire) - "Salubris Biotherapeutics, Inc...announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs....The ongoing Phase 1b/2, open label, dose escalation and cohort expansion study (NCT05620134) is designed to evaluate the safety and preliminary anti-tumor activity of JK08 in patients with unresectable locally, advanced or metastatic cancer....SalubrisBio plans to report additional data from this study in the second half of 2024. JK06 is positioned to be the first biparatopic ADC targeting a known tumor antigen for which no approved therapies currently exist. Given limited expression and internalization, this antigen is ideally suited for the biparatopic design intended to overcome both limitations, and JK06 has demonstrated low picomolar affinity and robust internalization of the target."

Financing • P1/2 data • Preclinical • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Gastric Adenocarcinoma • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer