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    DRUG CLASS:

    B7-H4-targeted antibody-drug conjugate

    Related drugs:
    6d
    Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=308, Recruiting, BeOne Medicines | N=227 --> 308
    Enrollment change • First-in-human
    |
    Avastin (bevacizumab) • Tevimbra (tislelizumab-jsgr)
    2ms
    BLUESTAR: A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies (clinicaltrials.gov)
    P1/2, N=370, Recruiting, AstraZeneca | Trial completion date: Mar 2027 --> Sep 2027 | Trial primary completion date: Mar 2027 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    puxitatug samrotecan (AZD8205) • saruparib (AZD5305) • rilvegostomig (AZD2936)
    2ms
    BEHOLD-2: A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=392, Recruiting, GlaxoSmithKline | Trial primary completion date: Sep 2027 --> Dec 2027
    Trial primary completion date
    |
    GSK5733584
    3ms
    Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I) (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    puxitatug samrotecan (AZD8205)
    3ms
    Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) (clinicaltrials.gov)
    P3, N=700, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open
    |
    paclitaxel • doxorubicin hydrochloride • puxitatug samrotecan (AZD8205)
    5ms
    Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) (clinicaltrials.gov)
    P3, N=700, Not yet recruiting, AstraZeneca
    New P3 trial
    |
    paclitaxel • doxorubicin hydrochloride • puxitatug samrotecan (AZD8205)
    5ms
    BEHOLD-1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=385, Recruiting, GlaxoSmithKline | N=240 --> 385 | Trial primary completion date: Oct 2026 --> Feb 2027
    Enrollment change • Trial primary completion date
    |
    GSK5733584
    6ms
    SGNB7H4V-001: A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=246, Terminated, Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Dec 2025 --> May 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> May 2025; The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns
    Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • felmetatug vedotin (PF-08046048)
    8ms
    SGNB7H4V-001: A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=236, Active, not recruiting, Seagen, a wholly owned subsidiary of Pfizer | N=572 --> 236 | Trial completion date: Nov 2027 --> Dec 2025 | Trial primary completion date: Nov 2027 --> Dec 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • felmetatug vedotin (PF-08046048)
    8ms
    Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=227, Recruiting, BeiGene | N=150 --> 227 | Trial completion date: Sep 2027 --> May 2028
    Enrollment change • Trial completion date
    |
    Tevimbra (tislelizumab-jsgr)
    8ms
    B7 Homolog 4 (B7-H4)-Directed Agents in Oncology Clinical Trials: A Review. (PubMed, J Immunother Precis Oncol)
    B7-H4-directed agents, particularly antibody-drug conjugates (ADCs) like puxitatug samrotecan (AZD8205), felmetatug vedotin (SGN-B7H4V), and GSK5733584, have demonstrated early clinical activity with promising response rates in triple-negative breast cancer (TNBC). Combination strategies, such as ADCs with anti-PD-1 or PARP inhibitor therapies, have also shown enhanced tumor regression in preclinical models and are the subject of several ongoing clinical trials. This review highlights the current landscape of B7-H4-targeted agents, their progress in clinical trials, and the potential for combination approaches to improve outcomes in B7-H4-expressing cancers.
    Review • Journal
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    puxitatug samrotecan (AZD8205) • felmetatug vedotin (PF-08046048) • GSK5733584
    8ms
    BEHOLD-2: A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=360, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting
    Enrollment open
    |
    GSK5733584