marked.bio

anti-PD-1 antibody · antibody

serplulimab

7 active trials across 5 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as HLX10, Hetronifly.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 3 4 Phase 1/2
KRAS G12C 2 2 Phase 2
KRAS G12D 2 2 Phase 2
BRAF V600E 1 2 Phase 2
MSI-H / dMMR 1 3 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of serplulimab.

  1. Henlius 2

Trials

7 of 11 trials shown

  1. A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance

    Not yet recruiting Phase 2 Jiangsu Cancer Institute & Hospital Started 2026Primary completion 2027-12 NCT07622550

    serplulimabfruquintinibXELOX

    Confirmed RAS/BRAF mutation by testing.

    BRAF V600EMetastatic Colorectal Cancer (CRC)

  2. Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma

    Not yet recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2026Primary completion 2031-12 NCT07772557

    oxaliplatinserplulimab

    …perative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR.

    MSI-H / dMMRGastric or Gastroesophageal Junction Adenocarcinoma

  3. 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

  4. Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer

    Recruiting Phase 2 Fudan University Started 2025Primary completion 2026-08 NCT06521866

    serplulimabChemotherapyTargeted therapy

    …mary tumor located in the cecum, ascending colon, and proximal transverse colon, and RAS (KRAS and NRAS) mutant-type (Cohorts C and D);

    KRAS G12CKRAS G12DAdvanced Colorectal Carcinoma, Immunotherapy

  5. Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer

    Recruiting Phase 2 Ruijin Hospital Started 2024Primary completion 2026-02 NCT06368141

    serplulimabcapecitabineoxaliplatin

    MSS/RAS mutation patients with clinical stages T3N1-2 and T4N0-2

    KRAS G12CKRAS G12DColon Cancer

  6. Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

    Active, not recruiting Phase 2 Guangdong Association of Clinical Trials Started 2023Primary completion 2026-07 NCT05957510

    serplulimabetoposidecarboplatinSOC

    …on, and the reports clearly indicate that they were non-small cell lung cancer containing EGFR mutations before transformation.

    EGFR exon 19 deletion / L858RSmall-cell Lung Cancer

  7. 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