^
    6d
    A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    10d
    Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=260, Recruiting, SystImmune Inc. | N=100 --> 260
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    20d
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=436, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    20d
    A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=428, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    cisplatin • carboplatin • pemetrexed • izalontamab brengitecan (BL-B01D1)
    20d
    A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=558, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    docetaxel • izalontamab brengitecan (BL-B01D1)
    27d
    A Study of HLX42 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=42, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1m
    IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1/2 trial • Metastases
    1m
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=382, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    2ms
    EGRET: First in Human Study of AZD9592 in Solid Tumors (clinicaltrials.gov)
    P1, N=162, Recruiting, AstraZeneca | N=108 --> 162
    Enrollment change • Combination therapy • Metastases
    |
    EGFR wild-type
    |
    Avastin (bevacizumab) • Tagrisso (osimertinib) • 5-fluorouracil • leucovorin calcium • tilatamig samrotecan (AZD9592)
    2ms
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=488, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    paclitaxel • docetaxel • irinotecan • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=488, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    paclitaxel • docetaxel • irinotecan • izalontamab brengitecan (BL-B01D1)
    2ms
    EGRET: First in Human Study of AZD9592 in Solid Tumors (clinicaltrials.gov)
    P1, N=108, Recruiting, AstraZeneca | Trial completion date: Mar 2025 --> Oct 2025 | Trial primary completion date: Mar 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR wild-type
    |
    Avastin (bevacizumab) • Tagrisso (osimertinib) • 5-fluorouracil • leucovorin calcium • tilatamig samrotecan (AZD9592)
    3ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    A Study of HLX42 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial • Metastases
    4ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=90 --> 121
    Enrollment change • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=58, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=288, Recruiting, Bliss Biopharmaceutical (Hangzhou) Co., Ltd | Phase classification: P1/2 --> P1 | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    Halaven (eribulin mesylate) • BB-1705
    5ms
    A Study of BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=98, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=50 --> 98
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=368, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov)
    P2, N=32, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Phase classification: P2a/2b --> P2
    Phase classification
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=190, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    6ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors (clinicaltrials.gov)
    P2, N=160, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=100 --> 160
    Enrollment open • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Nov 2025 | Initiation date: Jul 2023 --> Nov 2023 | Trial primary completion date: Jul 2025 --> Nov 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Recurrent Metastatic HER-2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=40 --> 58
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=40 --> 52 | Trial completion date: Aug 2025 --> Dec 2025 | Initiation date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2025 --> Dec 2025
    Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=50, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=368, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)
    7ms
    Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors (clinicaltrials.gov)
    P1, N=81, Active, not recruiting, AbbVie | Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2023 --> Feb 2024
    Trial completion date • Trial primary completion date • Adverse events • Combination therapy
    |
    EGFR expression • EGFR wild-type
    |
    Tagrisso (osimertinib) • docetaxel • ABBV-637
    7ms
    Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3-Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3-Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial. (PubMed, J Clin Oncol)
    HER3-DXd demonstrated a manageable safety profile and durable efficacy in heavily pretreated patients across clinical subtypes. These data warrant further evaluation of HER3-DXd in patients with HER3-expressing metastatic breast cancer.
    P1/2 data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive • HR positive • HER-2 negative • ERBB3 expression
    |
    patritumab deruxtecan (U3-1402)
    8ms
    A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    9ms
    A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    9ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=190, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    9ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    10ms
    First-in-human study of ABBV-637, an EGFR-targeting BCL-XL–inhibiting antibody-drug conjugate combined with osimertinib (OSI) in relapsed/refractory, EGFR-mutated non-small cell lung cancer (NSCLC) (ESMO 2023)
    Conclusions ABBV-637 plus OSI showed clinical activity and a manageable safety profile in patients with RR NSCLC. Biomarker data suggest that response to ABBV-637 plus OSI may be enriched by excluding patients with targetable bypass mechanisms; ongoing research is needed to confirm association of mutation and patient selection.
    P1 data
    |
    BCL2L1 (BCL2-like 1)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • ABBV-637
    10ms
    EGRET: First-in-human Study of the Novel Antibody-drug Conjugate AZD9592 ± Anti-cancer Agents in Advanced Solid Tumours (IASLC-WCLC 2023)
    Module 2 will evaluate AZD9592 in combination with osimertinib in patients with EGFRm mNSCLC. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Annual Meeting.
    P1 data • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR expression • EGFR wild-type • MET expression
    |
    Tagrisso (osimertinib) • tilatamig samrotecan (AZD9592)