JK06 / Shenzhen Salubris - LARVOL DELTA

A Phase 1b/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), in Patients with Unresectable Locally Advanced or Metastatic Cancer (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P1/2 data • Oncology

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 1b/2 study of JK06, a 5T4-targeted antibody-drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer. (ASCO 2026) - P1/2 | "To date, JK06 demonstrates promising emerging clinical activity in refractory NSCLC & breast cancer at multiple dose levels while being well tolerated without significant drug-related toxicities. Updated safety & clinical activity data from both dose escalation & expansion cohorts, including the initial assessment of dose randomization, will be presented."

ADC • Clinical • Metastases • P1/2 data • Alopecia • Breast Cancer • Dry Eye Disease • Immunology • Keratitis • Lung Cancer • Non Small Cell Lung Cancer • Ocular Inflammation • Oncology • Ophthalmology • Solid Tumor • CXCR4 • EGFR • TPBG

Salubris Biotherapeutics Announces Updated Phase 1/2 Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the 2026 American Society of Clinical Oncology Annual Meeting (Businesswire) - "Key Efficacy Findings: (i) NSCLC: Across all response-evaluable squamous NSCLC patients, JK06 achieved a confirmed ORR of 35% (6 of 17), including 50% (5 of 10) at 4.5 mg/kg, and a DCR of 94% (16 of 17). Across all response-evaluable EGFR-mutant NSCLC patients, JK06 achieved a confirmed ORR of 43% (3 of 7) and a DCR of 86% (6 of 7); (ii) Breast Cancer: Across all response-evaluable hormone receptor-positive (HR+) breast cancer patients, JK06 achieved a confirmed ORR of 30% (3 of 10) and a DCR of 60% (6 of 10). Across all response-evaluable triple-negative breast cancer (TNBC) patients, JK06 achieved a confirmed ORR of 25% (4 of 16) and a DCR of 69% (11 of 16)...; (iii) Other Tumor Types: One confirmed partial response was observed among two response-evaluable endometrial cancer patients, representing the fifth tumor type to demonstrate a response with JK06..."

P1/2 data • Breast Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

JK06.1.01: 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 (clinicaltrialsregister.eu) - P1/2 | N=305 | Recruiting | Sponsor: Salubris Biotherapeutics Inc. | N=210 ➔ 305

Enrollment change • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • EGFR • ER • PD-L1 • ROS1

A phase 1b / 2 study of JK06, a 5T4-targeted antibody drug conjugate, in patients with unresectable locally advanced or metastatic cancer (AACR 2026) - "To date, JK06 demonstrates promising clinical activity among refractory NSCLC and breast cancer at multiple dose levels while being well tolerated without significant drug-related toxicities. Updated dose escalation data and initial expansion cohort data will be presented."

ADC • Clinical • Metastases • P1 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AVEN • CXCR4 • TPBG

Salubris Biotherapeutics Presents Phase 1/2 Dose Escalation and Expansion Cohort Data for JK06, 5T4-Targeted Antibody Drug Conjugate, at the American Association for Cancer Research Annual Meeting (Businesswire) - "Among 38 response-evaluable NSCLC patients, 10 attained confirmed PRs (ORR 26%), including three out of seven response-evaluable squamous cell NSCLC patients (ORR 43%), and two of three response-evaluable Epidermal Growth Factor Receptor (EGFR) mutant patients. Five out of 19 response-evaluable breast cancer patients attained PRs (ORR 26%), including four out of nine hormone receptor-positive (HR+) breast cancer patients (ORR 44%). Among other tumor types, the first and only response-evaluable gastric cancer patient enrolled attained a partial response (PR, -55%), and one of four response-evaluable cervical cancer patients attained a partial response (PR, -49%)."

P1/2 data • Cervical Cancer • Gastric Cancer • Hormone Receptor Positive 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."

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

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 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

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