marked.bio

anti-PD-1 antibody · antibody

toripalimab

19 active trials across 16 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as JS001, Loqtorzi.

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
MSI-H / dMMR 5 12 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 4 6 Phase 2
ALK fusion 3 4 Phase 2
BRAF V600E 3 5 Phase 2
RET fusion or mutation 3 3 Phase 2
Claudin 18.2 expression 2 4 Phase 3
EGFR exon 19 deletion / L858R 2 4 Phase 2
KRAS G12C 2 2 Phase 1
KRAS G12D 2 2 Phase 1
MET exon 14 skipping 2 2 Phase 2
NTRK1/2/3 fusion 2 2 Phase 2
IDH1/2 mutation 1 1 Phase 2
ROS1 fusion 1 1 Phase 2
BRCA1/2 mutation 0 1 –
FGFR2 fusion or rearrangement 0 1 –
FGFR3 alteration (mutation or fusion) 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of toripalimab.

  1. RemeGen 3
  2. NingBo Junyan Hongshi Biosciences 1
  3. LaNova Medicines Zhejiang 1
  4. LaNova Medicines 1

Trials

19 of 37 trials shown

  1. JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 3 NingBo Junyan Hongshi Biosciences Started 2026Primary completion 2029-01 NCT07584135

    toripalimaboxaliplatincapecitabinesintilimab

    …t, or Metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the pa…

    Claudin 18.2 expressionGastric Adenocarcinoma

  2. Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-escalation (NeoScorch HN)

    Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2026Primary completion 2030-10 NCT07209189

    toripalimabcisplatincarboplatindocetaxel

    …sinonasal cancer, sinonasal undifferentiated carcinoma (e.g., Isocitrate dehydrogenase 2 (IDH2) mutant), or neuroendocrine sinonasal tumors (e.g., olfactory neuroblastoma) (cT2-cT4, N0-N3).

    IDH1/2 mutationHead and Neck Cancer, Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancer

  3. MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas

    Not yet recruiting Phase 2 Fudan University Started 2026Primary completion 2027-12 NCT07816770

    toripalimabaxitinib

    …e-deficient renal cell carcinoma, succinate dehydrogenase-deficient renal cell carcinoma, ALK-rearranged renal cell carcinoma, and renal cell carcinoma not otherwise specified or unclassified af…

    ALK fusionMetastatic Non-Clear Cell Renal Cell Carcinoma, Metastatic Renal Medullary Carcinomas

  4. Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)

    Recruiting Phase 2 First Affiliated Hospital of Zhejiang University Started 2026Primary completion 2028-02 NCT07383818

    trastuzumab rezetecantoripalimabNeoadjuvant Chemotherapy

    All patients must be pathohistologically confirmed as HR-positive/HER2-low.

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

  5. Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

    Recruiting Phase 2 RemeGen Started 2025Primary completion 2026-10 NCT06642545

    disitamab vedotinRC148Albumin-bound Paclitaxonetoripalimab

    Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory

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

  6. Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

    Recruiting Phase 2 Emory University Started 2025Primary completion 2029-07 NCT07140679

    toripalimab

    Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \[AJCC\] 8)

    MSI-H / dMMRLocalized Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8

  7. A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours

    Not yet recruiting Phase 2 LaNova Medicines Started 2025Primary completion 2028-01 NCT06873854

    LM-108toripalimab

    …s or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H/dMMR solid tumors.

    MSI-H / dMMRAdvanced Solid Tumor

  8. Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

    Recruiting Phase 2 Sun Yat-sen University Started 2025Primary completion 2028-04 NCT06903858

    toripalimab

    Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

    MSI-H / dMMRColorectal Cancer, Microsatellite Instability High, Mismatch Repair Deficiency

  9. Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression

    Recruiting Phase 2 Ruijin Hospital Started 2024Primary completion 2027-01 NCT06269211

    toripalimab

    Confirmation by the central laboratory that the tumor harbors EGFR mutations either sensitive mutations, uncommon mutations or complex mutations.

    EGFR exon 19 deletion / L858RCarcinoma, Non-Small-Cell Lung

  10. Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

    Recruiting Phase 2 Sun Yat-sen University Started 2024Primary completion 2026-07 NCT06547203

    cetuximab FDA EUtoripalimabirinotecan

    …ested as RAS/BRAF V600E wild-type and negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.

    BRAF V600EALK fusionRET fusion or mutationNTRK1/2/3 fusionStatus may be outdated, last updated 2024-08-09Colorectal Cancer Metastatic

  11. To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

    Recruiting Phase 2 RemeGen Started 2024Primary completion 2025-06 NCT06389006

    disitamab vedotintoripalimabEpirubicincyclophosphamide

    Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 pro…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-05-23Breast Cancer

  12. Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

    Recruiting Phase 2 Guangdong Provincial People's Hospital Started 2023Primary completion 2024-12 NCT05800340

    toripalimabnab-paclitaxelpemetrexedcarboplatin

    …h Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (…

    BRAF V600EMET exon 14 skippingRET fusion or mutationStatus may be outdated, last updated 2023-04-05Non-Small Cell Lung Cancer, RET Driver Mutation, BRAF V600 Mutation, Erb-B2 Receptor Tyrosine Kinase Exon 20 Mutation

  13. Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

    Recruiting Phase 2 RemeGen Started 2023Primary completion 2025-12 NCT06227117

    disitamab vedotintoripalimabcarboplatinSequential Epirubicincyclophosphamide

    Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC …

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-03-19Breast Cancer

  14. A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

    Recruiting Phase 2 LaNova Medicines Zhejiang Started 2023Primary completion 2031-08 NCT05934331

    LM-302toripalimabcapecitabineTegafur, Gimeracil and Oteracil Potassium Capsulesnivolumabapatinibgemcitabinetislelizumabanlotinibbenmelstobart

    CLDN18.2-positive subjects.

    Claudin 18.2 expressionMalignant Neoplasms of Digestive Organs

  15. Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

    Recruiting Phase 2 Yu jiren Started 2023Primary completion 2026-02 NCT05729646

    toripalimaboxaliplatinS1

    Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endosco…

    MSI-H / dMMRStatus may be outdated, last updated 2023-07-25Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Mismatch Repair Deficiency

  16. Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Li Zhang, MD Started 2022Primary completion 2025-11 NCT05003037

    surufatinibtoripalimabpemetrexedcarboplatincisplatin

    EGFR mutation cases are not expected to exceed 50% of all enrolled patients in Cohort 2.

    EGFR exon 19 deletion / L858RBRAF V600EMET exon 14 skippingALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon Small Cell Lung Cancer

  17. Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer

    Recruiting Phase 2 Sun Yat-sen University Started 2019Primary completion 2027-04 NCT03926338

    toripalimab

    …deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).

    MSI-H / dMMRColorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy

  18. Application of KRAS Vaccine in the Treatment of KRAS-mutated Malignancies

    Recruiting Phase 1 Sichuan University Started 2025Primary completion 2027-12 NCT07004244

    KRAS-mutated mRNA vaccinetoripalimabpemetrexedcarboplatin

    KRAS G12C/G12D/G12V/G13D mutation-positive by genomic testing.

    KRAS G12CKRAS G12DMalignant Tumors

  19. Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

    Recruiting Early Phase 1 Ruijin Hospital Started 2024Primary completion 2026-12 NCT06577532

    ABO2102toripalimab

    Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

    KRAS G12CKRAS G12DPancreatic Neoplasms, Other Solid Tumors