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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › Other monoclonal antibodies and antibody drug conjugates
ifinatamab deruxtecan
L01FX38
Forms & Strengths
- Lyophilized powder for injection: 100 mg per single-dose vial
Adult Dosing
- Recommended dosage varies by specific clinical trial protocol, typically administered as an intravenous infusion every 3 weeks (Q3W)
- Common investigational dose ranges from 8 mg/kg to 12 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Investigated primarily for the treatment of advanced solid tumors, including small cell lung cancer (SCLC) expressing B7-H3
Mechanism of Action
- Antibody-drug conjugate (ADC) directed against B7-H3 (CD276)
- Consists of a humanized anti-B7-H3 monoclonal antibody linked to a topoisomerase I inhibitor payload (exatecan derivative, DXd) via a tetrapeptide-based cleavable linker
- Binding to B7-H3 on tumor cells leads to internalization of the ADC and intracellular release of the cytotoxic payload, causing DNA damage and apoptotic cell death
Contraindications
- Known severe hypersensitivity to ifinatamab deruxtecan or any of its excipients
Adverse Reactions
- Interstitial lung disease (ILD) and pneumonitis (potentially fatal)
- Neutropenia, leukopenia, and anemia
- Nausea, decreased appetite, vomiting, and diarrhea
- Fatigue, alopecia, and musculoskeletal pain
- Elevated liver enzymes
Drug Interactions
- Strong CYP3A4 inhibitors or inducers may theoretically affect the metabolism of the released payload, though primarily metabolized by other pathways
- Concomitant use with other myelosuppressive agents can exacerbate bone marrow suppression
- Caution with other agents known to cause interstitial lung disease or pulmonary toxicity
Curated Content: Needs Vetting Before Put to Clinical Use