marked.bio

Company

Baili-Bio / SystImmune

13 active trials that select patients by a biomarker on marked.bio, across 6 biomarkers; 7 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).

izalontamab brengitecan 6BL-M07D1 5osimertinib 4pembrolizumab 1glecirasib 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

13 of 14 trials shown

  1. A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2026Primary completion 2030-12 NCT07640789

    izalontamab brengitecanosimertinib FDA EU

    …With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definiti…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer Stage III

  2. A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

    Recruiting Phase 2/3 Baili-Bio / SystImmune Started 2026Primary completion 2032-12 NCT07642024

    izalontamab brengitecanosimertinib FDA EUcarboplatinpemetrexedcisplatin

    …udy of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  3. A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2028-12 NCT06838273

    izalontamab brengitecanosimertinib FDA EU

    …sue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  4. A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2027-12 NCT07178795

    BL-M07D1pembrolizumabpemetrexedcarboplatincisplatin

    A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

    HER2 (ERBB2) activating mutationNon-squamous Non-small Cell Lung Cancer

  5. A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2027-05 NCT06957886

    BL-M07D1capecitabineeribulingemcitabinepaclitaxel

    Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;

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

  6. A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)

    Active, not recruiting Phase 3 Baili-Bio / SystImmune Started 2024Primary completion 2026-08 NCT06382116

    izalontamab brengitecanpemetrexedcisplatincarboplatin

    Documented classical EGFR mutations detected from tumor tissue or blood samples;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  7. SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

    Active, not recruiting Phase 2/3 Baili-Bio / SystImmune Started 2022Primary completion 2025-12 NCT05020769

    SI-B001osimertinib

    …all cell lung cancer (NSCLC) confirmed by histopathology and/or cytology, T790M-negative, Exon20ins mutation resistant to the third generation EGFR TKI after the first or second line treatm…

    EGFR exon 20 insertionNon-small Cell Lung Cancer

  8. A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Baili-Bio / SystImmune Started 2026Primary completion 2028-12 NCT07827261

    izalontamab brengitecanglecirasib

    A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    KRAS G12CNon-small Cell Lung Cancer

  9. A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

    Recruiting Phase 2 Baili-Bio / SystImmune Started 2026Primary completion 2028-12 NCT07678957

    BL-M07D1trastuzumab deruxtecan FDA EU

    Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；

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

  10. Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors

    Active, not recruiting Phase 1 Baili-Bio / SystImmune Started 2025Primary completion 2027-02 NCT07021066

    BL-M05D1

    …ented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2, as defined below, that have recurred or progressed on at least 1 line of prior systemic …

    Claudin 18.2 expressionGastric Adenocarcinoma, Advanced Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma, Biliary Tract Cancer

  11. Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

    Recruiting Phase 1 Baili-Bio / SystImmune Started 2023Primary completion 2030-04 NCT05983432

    izalontamab brengitecan

    a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the serine-i…

    EGFR exon 19 deletion / L858RHER2-low / ultralow (IHC 1+ or 2+/ISH-)Non Small Cell Lung Cancer, Esophageal Cancer, Small Cell Lung Cancer, Nasopharyngeal Cancer

  12. Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

    Recruiting Phase 1 Baili-Bio / SystImmune Started 2023Primary completion 2026-12 NCT05631964

    BL-M07D1

    Low HER2 expression: IHC 2+ and ISH negative, or IHC 1+.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Locally Advanced or Metastatic Digestive Tract Tumors, Other Solid Tumors

  13. A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors

    Recruiting Phase 1 Baili-Bio / SystImmune Started 2022Primary completion 2026-12 NCT05461768

    BL-M07D1

    HER2 low expression: IHC2+ and ISH negative, or IHC1+;

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, Locally Advanced or Metastatic Solid Tumor