marked.bio

anti-PD-1 antibody · antibody

tislelizumab

30 active trials across 13 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as BGB-A317, Tevimbra.

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
KRAS G12C 9 11 Phase 3
MSI-H / dMMR 7 14 Phase 3
Claudin 18.2 expression 6 6 Phase 3
KRAS G12D 6 8 Phase 1/2
BRAF V600E 2 5 Phase 1
EGFR exon 19 deletion / L858R 2 10 Phase 1/2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 3 Phase 3
ALK fusion 1 2 Phase 1/2
MET exon 14 skipping 1 1 Phase 3
BRCA1/2 mutation 0 2 –
FGFR2 fusion or rearrangement 0 1 –
FGFR3 alteration (mutation or fusion) 0 1 –
HER2 (ERBB2) activating mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of tislelizumab.

  1. BeOne Medicines (BeiGene) 2
  2. HiFiBiO Therapeutics 2
  3. AskGene Pharma 2
  4. Shanghai Jeyou Pharmaceutical 1
  5. Hansoh Pharma 1
  6. Allist Pharmaceuticals 1
  7. Novartis 1
  8. Genfleet Therapeutics 1
  9. ImmunityBio 1
  10. RemeGen 1
  11. Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 1
  12. Kelun-Biotech 1

Trials

30 of 53 trials shown

  1. A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

    Not yet recruiting Phase 3 Shanghai Jeyou Pharmaceutical Started 2026Primary completion 2029-04 NCT07833202

    ifebemtinibtislelizumabcarboplatinpemetrexed

    Has KRAS G12C mutation confirmed by central laboratory.

    KRAS G12CNSCLC

  2. A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

    Not yet recruiting Phase 3 Hansoh Pharma Started 2026Primary completion 2030-05 NCT07822542

    HS-10370adebrelimabcisplatincarboplatinpemetrexedtislelizumab

    Documentation of the presence of a KRAS G12C mutation

    KRAS G12CCarcinoma, Non-Small-Cell Lung

  3. Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.

    Recruiting Phase 3 Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Started 2026Primary completion 2028-10 NCT07385703

    LM-302tislelizumaboxaliplatincapecitabine

    After confirmation by the central laboratory, tumor tissue with positive CLDN18.2 expression is defined as ≥25% tumor cell membrane staining intensity 2+ \& 3+.

    Claudin 18.2 expressionAdenocarcinoma

  4. Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In

    Recruiting Phase 3 ImmunityBio Started 2025Primary completion 2028-09 NCT06745908

    N-803tislelizumabdocetaxelPrior failed checkpoint inhibitor

    …ase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.

    MET exon 14 skippingNSCLC Stage IV

  5. A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

    Not yet recruiting Phase 3 RemeGen Started 2025Primary completion 2028-05 NCT06944496

    disitamab vedotintislelizumaboxaliplatincapecitabine

    HER2-low expression

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Gastric Carcinoma

  6. JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation

    Recruiting Phase 3 Allist Pharmaceuticals Started 2024Primary completion 2029-09 NCT06416410

    glecirasibtislelizumabsitneprotafibpemetrexedcarboplatin

    G12C mutation confirmed by the central lab

    KRAS G12CAdvanced Non-squamous Non-small-cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer

  7. ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

    Active, not recruiting Phase 3 AskGene Pharma Started 2024Primary completion 2026-12 NCT06206733

    ASKB589oxaliplatincapecitabinetislelizumab

    CLDN 18.2 positive

    Claudin 18.2 expressionGastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma

  8. Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer

    Recruiting Phase 3 Sun Yat-sen University Started 2024Primary completion 2027-11 NCT06520683

    tislelizumabAdjuvant chemotherapy

    dMMR and/or MSI-H colorectal carcinoma that undergo surgical resection

    MSI-H / dMMRColorectal Cancer, Microsatellite Instability High

  9. Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease

    Not yet recruiting Phase 1/2 National University Hospital, Singapore Started 2026Primary completion 2028-08 NCT07681297

    tislelizumabbevacizumabcapecitabine

    Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one …

    EGFR exon 19 deletion / L858RALK fusionAdvanced Solid Tumor Cancer, Triple-Negative Breast Cancer (TNBC), CNS Disease, Breast Cancer

  10. This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.

    Not yet recruiting Phase 1/2 Genfleet Therapeutics Started 2026Primary completion 2027-12 NCT07846358

    GFH276tislelizumabpemetrexedcisplatincarboplatin

    Confirmed RAS mutation or KRAS amplification；tumor cell PD L1 test report available

    KRAS G12CKRAS G12DRAS Mutation, Non-small Cell Lung Cancer (NSCLC)

  11. Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma

    Recruiting Phase 2 Ruijin Hospital Started 2026Primary completion 2028-04 NCT07569068

    tislelizumabLM-302oxaliplatin

    Claudin 18.2 positive (≥25% of tumor cells showing moderate-to-strong membrane staining);

    Claudin 18.2 expressionGastric or Esophagogastric Junction Adenocarcinoma

  12. SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

    Not yet recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2028-06 NCT07609667

    tislelizumabSKB315 for injectioncapecitabine

    …r tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;

    Claudin 18.2 expressionGastroesophageal Junction Adenocarcinoma

  13. Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

    Recruiting Phase 2 Shanghai Chest Hospital Started 2024Primary completion 2025-11 NCT06659042

    tislelizumabcisplatincarboplatinpemetrexed

    With Known KRAS gene mutation.

    KRAS G12CKRAS G12DLung Cancer, Non-Small Cell

  14. Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

    Not yet recruiting Phase 1/2 Shanghai Chest Hospital Started 2024Primary completion 2026-06 NCT06456138

    trametinibanlotinibtislelizumab

    KRAS mutation positive detected by ARMS or NGS;

    KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-06-13KRAS Mutation-Related Tumors, Advanced Lung Cancer, Refractory Tumor

  15. Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

    Not yet recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2026-06 NCT06547476

    tislelizumabanlotinib

    Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-08-09Breast Cancer

  16. Tislelizumab in People With Colorectal Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2024Primary completion 2028-07 NCT06529523

    tislelizumab

    Confirmation of dMMR by immunohistochemistry

    MSI-H / dMMRColorectal Cancer

  17. 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

  18. ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

    Active, not recruiting Phase 1/2 AskGene Pharma Started 2023Primary completion 2025-10 NCT05632939

    CAPOXsintilimabtislelizumab

    Tumor tissue samples are CLDN18.2 positive detected by central laboratory

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Cancer (GC)

  19. Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations

    Not yet recruiting Phase 2 China Medical University Started 2023Primary completion 2025-12 NCT06118658

    tislelizumab

    …or the study 2.Age and gender: ≥18 years old and≤75 years old, both men and women. 3.dMMR/MSI-H or POLE/POLD1 gene mutation was confirmed by immunohistochemical PCR or NGS 4.0-1 physica…

    MSI-H / dMMRStatus may be outdated, last updated 2023-11-07Gastric, Colorectal Adenocarcinoma

  20. Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

    Active, not recruiting Phase 1/2 Indaptus Therapeutics Started 2023Primary completion 2027-06 NCT05651022

    Decoy20tislelizumab

    …nd neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), dMMR/MSI-High tumor (Part 2c only).

    MSI-H / dMMRSolid Tumor, Adult, HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Pancreatic Adenocarcinoma

  21. Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

    Not yet recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University Started 2023Primary completion 2024-12 NCT05841134

    tislelizumabcapecitabineoxaliplatin

    The tissue specimens are confirmed as MSI-H by PCR or NGS.

    MSI-H / dMMRStatus may be outdated, last updated 2023-05-09MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin, Capecitabine

  22. A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.

    Not yet recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University Started 2022Primary completion 2023-09 NCT05231850

    tislelizumab

    Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or…

    MSI-H / dMMRStatus may be outdated, last updated 2022-02-09Colon Cancer

  23. Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

    Active, not recruiting Phase 1/2 Novartis Started 2021Primary completion 2027-01 NCT04699188

    opnurasibbatoprotafibtislelizumab

    Adult patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care or are intolerant or ineligible to…

    KRAS G12CKRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung

  24. Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

    Recruiting Phase 2 BeOne Medicines (BeiGene) Started 2018Primary completion 2026-11 NCT03736889

    tislelizumab

    Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR

    MSI-H / dMMRMSI-H/dMMR Solid Tumors

  25. Phase 1 Study of ATRA Plus a PD-1 Inhibitor in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Resistance

    Not yet recruiting Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2026Primary completion 2028-10 NCT07842887

    All-trans retinoic acidtislelizumab

    …sensitizing EGFR mutation, including but not limited to an exon 19 deletion or an exon 21 L858R mutation.

    EGFR exon 19 deletion / L858REGFR-TKI-resistant Non-Small Cell Lung Cancer

  26. A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer

    Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2028-06 NCT07671339

    ELI-002tislelizumabmFOLFIRINOX

    Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D.

    KRAS G12CKRAS G12DPancreatic Cancer

  27. A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations

    Recruiting Phase 1 BeOne Medicines (BeiGene) Started 2026Primary completion 2028-09 NCT07746141

    BG-85738tislelizumabcetuximab

    Participants must have evidence of a RAS mutation defined as a nonsynonymous mutation in Kirsten rat sarcoma viral oncogene homolog (KRAS),…

    KRAS G12DRAS Mutation, Advanced Solid Tumor, Metastatic Solid Tumor

  28. A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

    Active, not recruiting Phase 1 HiFiBiO Therapeutics Started 2023Primary completion 2026-12 NCT05789069

    HFB200603tislelizumab

    BRAF V600E positive: must have received at least 2 lines of therapy

    BRAF V600ERenal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Gastric Cancer

  29. A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors

    Active, not recruiting Phase 1 HiFiBiO Therapeutics Started 2022Primary completion 2026-12 NCT05238883

    HFB200301tislelizumab

    BRAF V600E mutant: must have received at least 2 lines of therapy

    BRAF V600EGastric Cancer, Renal Cell Carcinoma, Melanoma, Sarcoma

  30. Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors

    Not yet recruiting No phase Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2026Primary completion 2026-10 NCT07396090

    eDC-KRAS vaccinetislelizumab

    …on-small cell lung cancer, etc.) and harboring at least one of the targeted KRAS mutants （G12C/D/R/V）

    KRAS G12CKRAS G12DAdvanced Solid Tumor