marked.bio

Company

Henlius

4 active trials that select patients by a biomarker on marked.bio, across 2 biomarkers; 1 in phase 3.

Counts only trials this company leads as sponsor, not partnered or academic trials of its drugs.

Biomarkers

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

HLX43 2serplulimab 2pembrolizumab 1trastuzumab deruxtecan 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

Trials

4 of 15 trials shown

  1. A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

    Not yet recruiting Phase 3 Henlius Started 2025Primary completion 2027-04 NCT06847334

    HLX17pembrolizumab

    Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.

    ROS1 fusionNon-Squamous Non-Small Cell Lung Cancer

  2. A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

    Recruiting Phase 1/2 Henlius Started 2025Primary completion 2026-10 NCT06848699

    HLX43serplulimab

    … /metastatic NSCLC subjects confirmed by histology or cytology, requiring the presence of EGFR mutation and failure or intolerance to EGFR-TKI or/and platinum-based chemotherapy.

    EGFR exon 19 deletion / L858RSolid Tumor Cancer, Non Small Cell Lung Cancer

  3. A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

    Recruiting Phase 2 Henlius Started 2025Primary completion 2027-06 NCT06832202

    HLX22trastuzumab deruxtecan FDA EU

    With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)HER2-low Hormone Receptor Positive Breast Cancer

  4. A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

    Enrolling by invitation Phase 1 Henlius Started 2023Primary completion 2026-12 NCT06115642

    HLX43serplulimab

    The standard treatment for non-squamous NSCLC with known EGFR mutations is defined as EGFR inhibitors and platinum-containing chemotherapy.

    EGFR exon 19 deletion / L858RAdvanced/Metastatic Malignant Solid Tumors