marked.bio

anti-PD-1 antibody · antibody

sintilimab

25 active trials across 14 of our biomarkers, targeting PD-1. Not approved for any biomarker on marked.bio yet.

Also known as IBI308, Tyvyt.

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 9 12 Phase 2/3
EGFR exon 19 deletion / L858R 5 8 Phase 1/2
Claudin 18.2 expression 4 5 Phase 3
KRAS G12C 4 4 Phase 3
BRAF V600E 3 3 Phase 4
KRAS G12D 2 2 Phase 3
ALK fusion 1 2 Phase 2
BRCA1/2 mutation 1 2 Phase 2
EGFR exon 20 insertion 1 2 Phase 3
NTRK1/2/3 fusion 1 1 Phase 4
RET fusion or mutation 1 1 Phase 4
ROS1 fusion 1 1 Phase 2
FGFR2 fusion or rearrangement 0 2 –
FGFR3 alteration (mutation or fusion) 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of sintilimab.

  1. Innovent Biologics 4
  2. Avistone Biotechnology 1
  3. Suzhou Abogen Biosciences 1
  4. NingBo Junyan Hongshi Biosciences 1
  5. AskGene Pharma 1

Trials

25 of 37 trials shown

  1. Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

    Not yet recruiting Phase 4 Fujian Medical University Started 2025Primary completion 2027-12 NCT07010393

    dabrafenib FDA EUtrametinib FDA EUselpercatinibpralsetiniblenvatiniblarotrectinibanlotinibpembrolizumabsintilimabcabozantinibBemosuzumab

    BRAF V600E mutation

    BRAF V600ERET fusion or mutationNTRK1/2/3 fusionThyroid Neoplasms

  2. 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

  3. Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

    Recruiting Phase 2/3 Fudan University Started 2026Primary completion 2027-12 NCT07319429

    sintilimabMedroxyprogesterone Acetate 500 MGMegestrol Acetate 160 MGletrozole

    2). dMMR (deficient mismatch repair)/MSI-H endometrial cancer: Pathologically and radiologically evaluated as FIGO 2023 Stage I-II e…

    MSI-H / dMMREndometrial Cancer, Fertility

  4. Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

    Enrolling by invitation Phase 3 Avistone Biotechnology Started 2023Primary completion 2028-06 NCT06281964

    PLB1004pemetrexedcarboplatincisplatinsintilimab

    Tumor tissue is positive for EGFR Ex20ins as documentally confirmed by next-generation sequencing (NGS) testing or written confirma…

    EGFR exon 20 insertionNon-Small-Cell Lung Cancer

  5. A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

    Active, not recruiting Phase 3 Innovent Biologics Started 2023Primary completion 2028-04 NCT05890742

    sintilimab

    MSI-H or dMMR.

    MSI-H / dMMRMSI-H

  6. Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer

    Active, not recruiting Phase 3 Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2022Primary completion 2026-12 NCT05171660

    sintilimabbevacizumaboxaliplatincapecitabine

    RAS mutation, BRAF V600E wild type, and microsatellite stable

    KRAS G12CKRAS G12DColorectal Cancer Stage IV

  7. PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

    Recruiting Phase 3 Sun Yat-sen University Started 2022Primary completion 2026-06 NCT05236972

    sintilimaboxaliplatincapecitabine

    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 2022-12-30Colorectal Carcinoma

  8. Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

    Not yet recruiting Phase 1/2 Innovent Biologics Started 2026Primary completion 2027-06 NCT07612137

    IBI3005sintilimabbevacizumablimertinibosimertinib FDA EUcarboplatin

    Tumor harboring EGFR-sensitive mutations (Ex19del or L858R, with or without other EGFR mutations) confirmed via histology or cytology speci…

    EGFR exon 19 deletion / L858RSolid Tumor

  9. Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC

    Recruiting Phase 2 Jianxing He Started 2026Primary completion 2027-03 NCT07492342

    fulzerasibsintilimab

    All subjects must have a written test report before enrollment to prove the presence of KRAS G12C mutation

    KRAS G12CResectable NSCLC, KRAS G12C Mutation, Stage IB-IIIA NSCLC, Neoadjuvant Therapy

  10. A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2027-12 NCT07506109

    ipilimumabsintilimabcetuximab FDA EUdabrafenib FDA EU

    Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.

    BRAF V600EBRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable)

  11. IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Innovent Biologics Started 2026Primary completion 2030-06 NCT07483567

    IBI343sintilimaboxaliplatin

    Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.

    Claudin 18.2 expressionCLDN18.2 Positive, Primary Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

  12. A Phase II Study of Ipilimumab N01 Plus Sintilimab for MSI-H or dMMR Gastric and Gastroesophageal Junction Cancer

    Not yet recruiting Phase 2 Fudan University Started 2026Primary completion 2028-10 NCT07878221

    ipilimumab FDA EUsintilimab

    MSI-H by microsatellite instability testing (using the 5 microsatellite loci recommended by the…

    MSI-H / dMMRGastric / Gastroesophageal Junction Adenocarcinoma

  13. Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer

    Not yet recruiting Phase 2 Wang Jianliu Started 2026Primary completion 2030-07 NCT07731607

    sintilimab

    …etrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).

    MSI-H / dMMRMMRd Endometrial Cancer of Stage I~II

  14. A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma

    Recruiting Phase 2 Fudan University Started 2026Primary completion 2029-02 NCT07492615

    sintilimaboxaliplatin

    …(dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.

    MSI-H / dMMRGastric Cancer or Gastroesophageal Junction Adenocarcinoma

  15. Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant NSCLC

    Not yet recruiting Phase 2 Shanghai Chest Hospital Started 2025Primary completion 2026-03 NCT06688656

    pemetrexedcarboplatinsintilimab

    …ically, cytologically, or hematologically confirmed presence of EGFR-sensitive mutations (Ex19del, L858R), with co-existing driver mutations allowed;

    EGFR exon 19 deletion / L858RLung Cancer

  16. A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

    Not yet recruiting Phase 2 Wen-zhao ZHONG Started 2025Primary completion 2027-12 NCT07038460

    limertinibsintilimabosimertinib FDA EU

    …ollowed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

    EGFR exon 19 deletion / L858RResectable Non-small Cell Lung Cancer

  17. IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

    Recruiting Phase 1/2 Ruijin Hospital Started 2025Primary completion 2027-07 NCT07025889

    IBI343sintilimaboxaliplatinS-1

    Has histopathologically confirmed CLDN18.2-positive disease. 6.

    Claudin 18.2 expressionGastric Cancer

  18. Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction

    Not yet recruiting Phase 2 Hunan Province Tumor Hospital Started 2024Primary completion 2027-10 NCT06604351

    sintilimabnab-paclitaxelcarboplatin

    …all cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-19Non-Small Cell Lung Cancer

  19. Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

    Not yet recruiting Phase 2 Xijing Hospital Started 2024Primary completion 2026-07 NCT06459921

    sintilimab

    5\. deficient mismatch repair identified by pathological detection.

    MSI-H / dMMRStatus may be outdated, last updated 2024-10-10Neoadjuvant Chemotherapy, Sintilimab, Locally Advanced Gastric Cancer

  20. Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer

    Recruiting Phase 2 Yugui Lian Started 2024Primary completion 2027-11 NCT06698757

    sintilimab

    immunohistochemistry of tumor biopsy indicating deficient mismatch repair (dMMR), defined by the loss of expression of one or more of the four proteins MSH1, MSH2,…

    MSI-H / dMMRColorectal Cancer

  21. 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)

  22. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

  23. Study of ABO2102 in KRAS-Mutated Solid Tumors

    Recruiting Phase 1 Suzhou Abogen Biosciences Started 2026Primary completion 2029-06 NCT07455617

    ABO2102 Injectionsintilimab

    …e genetic testing during the screening period, with evidence of harboring any of required KRAS mutations

    KRAS G12CKRAS G12DAdvanced / Metastatic Solid Tumor

  24. Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

    Recruiting Phase 1 Innovent Biologics Started 2022Primary completion 2025-05 NCT05504278

    fulzerasibcetuximabpemetrexedcarboplatinsintilimabcisplatin

    Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

    KRAS G12CAdvanced Non-Small Cell Lung Cancer

  25. PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer

    Recruiting No phase Peking University People's Hospital Started 2024Primary completion 2029-07 NCT06549855

    sintilimabpembrolizumab FDA EU

    Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation se…

    MSI-H / dMMREndometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency