Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients with Advanced or Metastatic Solid Tumors
Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients with Advanced or Metastatic Solid Tumors
NCT #
not yet registered
Condition(s)
Solid Tumors
Molecular Target(s)
4-1BB, PD-L1
Drug Classification(s)
Bispecific Antibodies
Agents(s)
TAK-676 is a synthetic cyclic dinucleotide (CDN) exhibiting highly selective binding and activation of STING pathway.
Phase(s)
I
Mechanism of Action
BH3120 is a PD-L1 x 4-1BB Bispecific Monoclonal Antibody
Purpose
- How much of the study can be given with an acceptable level of side effects • The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- How the study is acting on your body
- Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
- PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1) as assessed by Immunohistochemistry (IHC) staining with either anti-PD-L1 SP263 or 22C3 antibody.
- Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥3 months before starting BH3120.
- Has received prior therapy with an anti-4-1BB(CD137) agent.
- History of any of the following toxicities associated with a prior immunotherapy:
- Grade ≥3 irAE that was considered related to previous immunotherapy and required immune suppressive therapy;
- Grade ≥2 hepatic function-related adverse event that persisted more than 1 week, and that was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy (previous immunotherapies include any anti-CD137, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Patient’s interval from the prior therapy to the first dose of BH3120 is less than 4 weeks for systemic anticancer therapy including investigational agents (or less than 5 half-lives for investigational/ non-cytotoxic agents, whichever is shorter). Upon discussion with the Medical Monitor, shorter wash-out period may be allowed provided that the patient has adequately recovered from any clinically relevant toxicity.
Has received prior therapy with an anti-4-1BB(CD137) agent. Therapeutic or experimental monoclonal antibodies in last 60 days prior to screening
Location
MCD
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