Ifinatamab Deruxtecan (I-DXd)

BIOLOGICAL5 trials

Conditions

Advanced Solid TumorCarcinoma, Non-Small-Cell LungExtensive-stage Small-cell Lung CancerMalignant Solid TumorNeuroendocrine CarcinomaSmall Cell Lung CancerSmall-Cell Lung Cancer

Phase 1

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

RecruitingNCT04145622

Daiichi SankyoAdvanced Solid Tumor, Malignant Solid Tumor

Start: 2019-11-03End: 2029-10-31Target: 250Updated: 2026-01-28

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

RecruitingNCT04165070

Merck Sharp & Dohme LLCCarcinoma, Non-Small-Cell Lung

Start: 2019-12-19End: 2032-02-13Target: 450Updated: 2026-03-16

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

Active, not recruitingNCT04471727

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Neuroendocrine Carcinoma, Small-Cell Lung Cancer

Start: 2020-12-14End: 2028-01-28Target: 232Updated: 2026-02-24

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

RecruitingNCT06780137

Merck Sharp & Dohme LLCSmall Cell Lung Cancer

Start: 2025-02-27End: 2030-01-17Target: 262Updated: 2026-03-24

Phase 2

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Active, not recruitingNCT05280470

Daiichi SankyoExtensive-stage Small-cell Lung Cancer

Start: 2022-03-09End: 2026-12-15Updated: 2026-02-25

Cancer Research2026-04-03

Data from Preclinical Activity of the DLL3-Targeted T-cell Engager MK-6070 in Neuroendocrine Prostate Cancer

2026-02-04

Preclinical activity of the DLL3-targeted T cell engager MK-6070 in neuroendocrine prostate cancer.

2025-10-03

KEYMAKER-U01 substudy 01A: Phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non–small-cell lung cancer.

Journal of Clinical Oncology2025-05-28

Updated results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine cancers (NEC).

Journal of Clinical Oncology2024-06-0127 citations

IDeate-Lung02: A phase 3, randomized, open-label study of ifinatamab deruxtecan (I-DXd) vs treatment of physician’s choice (TPC) in relapsed small cell lung cancer (SCLC).

Journal of Clinical Oncology2024-06-0112 citations

Interim results from a phase 1/2 study of HPN328, a tri-specific, half-life (T1/2) extended DLL3-targeting T-cell engager, in patients (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN).

Journal of Clinical Oncology2024-01-2925 citations

Abstract 5070: Anti-tumor activity of HPN328, a DLL3-targeting tri-specific, half-life extended T cell engager, is enhanced by combining with an anti-PD-L1 antibody in an immunocompetent mouse model

Cancer Research2023-04-042 citations

Abstract 4131: Long-term anti-tumor immunity induced by of HPN328, a DLL3-targeting trispecific, half-life extended T cell engager, in a preclinical immunocompetent mouse model

Cancer Research2023-04-041 citations

Interim results of an ongoing phase 1/2a study of HPN328, a tri-specific, half-life extended, DLL3-targeting, T-cell engager, in patients with small cell lung cancer and other neuroendocrine cancers.

Journal of Clinical Oncology2022-06-0145 citations

DS-7300 (B7-H3 DXd-ADC) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): A subgroup analysis of a phase 1/2 multicenter study.

Journal of Clinical Oncology2022-02-1618 citations

Abstract 1573: Combinatorial antitumor effects of CD3-based trispecific T cell activating constructs (TriTACs) and checkpoint inhibitors in preclinical models

Cancer Research2021-07-012 citations

A phase I/II, two-part, multicenter, first-in-human study of DS-7300a in patients with advanced solid malignant tumors.

Journal of Clinical Oncology2020-05-2013 citations

Ifinatamab Deruxtecan (I-DXd)

Sponsors

Conditions

Phase 1

Phase 2

Related Papers