marked.bio

EGFR-HER3 bispecific ADC · ADC

izalontamab brengitecan

10 active trials across 3 of our biomarkers, targeting EGFR x HER3. Not approved for any biomarker on marked.bio yet.

Also known as BL-B01D1, iza-bren.

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 8 8 Phase 3
KRAS G12C 2 2 Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 1 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of izalontamab brengitecan.

  1. Baili-Bio / SystImmune 6
  2. Bristol Myers Squibb 3

Trials

10 of 10 trials shown

  1. Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

    Recruiting Phase 3 Bristol Myers Squibb Started 2026Primary completion 2031-12 NCT07680790

    izalontamab brengitecanosimertinib FDA EUpemetrexedcarboplatincisplatin

    Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  2. 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

  3. 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

  4. Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

    Recruiting Phase 2/3 Bristol Myers Squibb Started 2025Primary completion 2028-12 NCT07100080

    izalontamab brengitecancarboplatincisplatinpemetrexed

    Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  5. 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

  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. 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

  8. A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2031-02 NCT06618287

    izalontamab brengitecanosimertinib FDA EUpembrolizumabnivolumabpumitamig

    …ants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, w…

    EGFR exon 19 deletion / L858RLung Cancer, Breast Cancer

  9. Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial

    Recruiting Phase 1 M.D. Anderson Cancer Center Started 2026Primary completion 2027-12 NCT07382726

    adagrasib FDA EUizalontamab brengitecan

    Tumor must harbor a KRAS G12C mutation.

    KRAS G12CNon-small Cell Lung Cancer

  10. 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