ReviewThe AAPS journal2015
Antibody Drug Conjugates: Nonclinical Safety Considerations.
Review in The AAPS journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 108 citations in OpenAlex.
- First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- From Dual Targeting to Clinical Validation: A Translational Framework for Bispecific Antibody-Drug Conjugates.International journal of molecular sciences · 2026Review
- Targeted antibody-drug conjugates for rhabdomyosarcoma and other FGFR4-expressing cancers.Cell reports. Medicine · 2026Article
- From Unmet Medical Need to Drug Candidate: A Translational Therapeutic Development Roadmap Illustrated by Dual-Payload Antibody-Drug Conjugates.Biomolecules · 2026Review
- Bispecific antibody-drug conjugates: a modular blueprint for next-generation cancer therapeutics.Archives of pharmacal research · 2026Review
- Engineered calcium-regulated affinity protein for efficient internalization and lysosomal toxin delivery.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Inhibiting TROP2 in advanced non-small-cell lung cancer with sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan: similarities and differences.Cancer chemotherapy and pharmacology · 2025Review
- Site-specific ligase-dependent conjugation with ring-opening linker improves safety and stability of HER2-targeting ADCs.Nature communications · 2025Article
- Strategic and Chemical Advances in Antibody-Drug Conjugates.Pharmaceutics · 2025Review
- Evaluation of antigen agnostic anti-tumor activity and immune memory induced by CBX-15 (alphalexImmunotherapy · 2025Article
- The next frontier in antibody-drug conjugates: challenges and opportunities in cancer and autoimmune therapy.Cancer drug resistance (Alhambra, Calif.) · 2025Review
- Risk Signals of Antibody-Drug Conjugates in Bladder Cancer: A Real-World FAERS Study.Clinical epidemiology · 2025Article
- Advancements in research and clinical management of interstitial lung injury associated with ADC drugs administration in breast cancer.Discover oncology · 2024Review
- FZ-AD005, a Novel DLL3-Targeted Antibody-Drug Conjugate with Topoisomerase I Inhibitor, Shows Potent Antitumor Activity in Preclinical Models.Molecular cancer therapeutics · 2024Article
- Unlocking the potential of bispecific ADCs for targeted cancer therapy.Frontiers of medicine · 2024Review
- Immune-related adverse events of antibody-based biological medicines in cancer therapy.Journal of cellular and molecular medicine · 2024Review
- Antibody-Drug Conjugates-Evolution and Perspectives.International journal of molecular sciences · 2024Review
- A simple and highly sensitive LC-MS workflow for characterization and quantification of ADC cleavable payloads.Scientific reports · 2024Article
- Trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody-drug conjugate with topoisomerase I inhibitor payload, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2/neu expression.Gynecologic oncology · 2023Article
- Antibody-drug conjugates and bispecific antibodies targeting cancers: applications of click chemistry.Archives of pharmacal research · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Antibody drug conjugates (ADCs) are biopharmaceutical molecules consisting of a cytotoxic small molecule covalently linked to a targeted protein carrier via a stable cleavable or noncleavable linker. The process of conjugation yields a highly complex molecule with biochemical properties that are distinct from those of the unconjugated components. The impact of these biochemical differences on the safety and pharmacokinetic (PK) profile of the conjugate must be considered when determining the types of nonclinical safety studies required to support clinical development of ADCs. The hybrid nature of ADCs highlights the need for a science-based approach to safety assessment that incorporates relevant aspects of small and large molecule testing paradigms. This thinking is reflected in current regulatory guidelines, where sections pertaining to conjugates allow for a flexible approach to nonclinical safety testing. The aim of this article is to review regulatory expectations regarding early assessment of nonclinical safety considerations and discuss how recent advances in our understanding of ADC-mediated toxicity can be used to guide the types of nonclinical safety studies needed to support ADC clinical development. The review will also explore nonclinical testing strategies that can be used to streamline ADC development by assessing the safety and efficacy of next generation ADC constructs using a rodent screen approach.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.