ifinatamab deruxtecan (DS-7300) / Daiichi Sankyo, Merck (MSD) - LARVOL DELTA

A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (clinicaltrials.gov) - P1/2 | N=360 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Feb 2030 ➔ Apr 2031 | Trial primary completion date: Feb 2030 ➔ Apr 2031

Monotherapy • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small-Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Trial. (PubMed, J Clin Oncol) - "I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified."

Journal • P2 data • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • CD276

IDeate-Prostate01: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN VERSUS DOCETAXEL IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P3 | "Recruitment is ongoing. "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Study (IASLC-WCLC 2025) - P2 | "These results demonstrate the remarkable efficacy of I-DXd 12 mg/kg in patients with pretreated ES-SCLC, a population for whom there is a substantial unmet need, with clinical benefit observed regardless of platinum sensitivity or prior treatments. I-DXd 12 mg/kg had a manageable safety profile that was consistent with prior data, with no new safety signals observed."

P2 data • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • Small Cell Lung Cancer • Solid Tumor • CD276

A phase Ib/II study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer (ES-SCLC) (ESMO 2025) - P1/2 | "Secondary objectives are to evaluate duration of response and progression-free survival by investigator assessment per RECIST v1.1 (part 1) and to characterize the pharmacokinetics and immunogenicity of gocatamig plus I-DXd combination therapy (part 1), I-DXd monotherapy (part 1), and gocatamig monotherapy (part 2). The 6070-002 study will enroll participants in Australia, Chile, China, Israel, Japan, South Korea, Spain, Türkiye, the United States of America, and other sites as the expansion gets underway."

P1/2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

IDeate-Prostate02: A phase 1/2, open-label umbrella substudy of ifinatamab deruxtecan-based treatment combinations or as monotherapy in participants with previously treated metastatic castration-resistant prostate cancer. (ASCO-GU 2026) - P1/2 | "Two monotherapy arms, each with ~80 to ~120 participants, will enroll participants into the Efficacy Phase; Arm 1: docetaxel and Arm 2: I-DXd. Two I-DXd combination arms will enroll participants into the Safety Lead-in (n~10), followed by Efficacy (n~50) phases: Arm 3: I-DXd+MK-5684, and Arm 4: I-DXd+ARPI...Previously presented at 26th Annual Meeting of the Society of Urologic Oncology; December 2–5, 2025; Phoenix, AZ. bid, twice daily; IV, intravenously; po, orally; q3w, every 3 weeks; qd, once daily."

Clinical • First-in-human • Metastases • Monotherapy • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

BCG041: A first-in-class bispecific ADC targeting B7-H3 and the proximal membrane region of MUC1 with superior antitumor activity (AACR 2026) - "In vitro, BCG041 demonstrated stronger binding and faster internalization than naked DS-7300 or Gatipotuzumab analogs across multiple tumor cell lines. Pharmacokinetic evaluation revealed a favorable ADC profile, and this drug demonstrates excellent developability, with CMC cell-line development currently ongoing. Together, these data position BCG041 as a highly promising next-generation bispecific ADC for B7-H3/MUC1-positive malignancies, addressing significant unmet clinical needs in breast, lung, gastro-esophageal, head-and-neck, colorectal, prostate, and ovarian cancers."

ADC • Bispecific • Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • CD276 • MUC1

Ifinatamab Deruxtecan (I-DXd) in Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Interim Analysis of Ideate-lung01 (IASLC-WCLC 2024) - P2, P3 | "No new safety signals were observed; TEAEs were more frequent in the 12 mg/kg cohort. Twelve mg/kg was selected as the optimal I-DXd dose for the extension part of IDeate-Lung01 and for the Phase 3 IDeate-Lung02 study (NCT06203210)."

Fatigue • Gastrointestinal Disorder • Hematological Disorders • Interstitial Lung Disease • Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • CD276

Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients (pts) with extensive-stage (ES) small cell lung cancer (SCLC) and baseline (BL) brain metastases (BM): Primary analysis of IDeate-Lung01 (ESMO 2025) - P2 | "Table: 2760MO All pts with BL BM (N=65) No prior brain RT for BL BM (n=26) With prior brain RT for BL BM (n=39) BL brain TL (n=29) CNS ORR, n (%) 30 (46) 15 (58) 15 (38) 19 (66) 95% CI 34–59 37–77 23–55 46–82 CNS best overall response, n (%) Complete response 20 (31) 12 (46) 8 (21) 9 (31) Partial response 10 (15) 3 (12) 7 (18) 10 (34) Stable disease 29 (45) 9 (35) 20 (51) 9 (31) Progressive disease 1 (2) 0 1 (3) 0 Not evaluable 5 (8) 2 (8) 3 (8) 1 (3) CNS disease control rate, n (%) 59 (91) 24 (92) 35 (90) 28 (97) CNS duration of response, median (95% CI), months 6.2 (4.0–7.9) 6.7 (3.1–not estimable) 5.1 (3.0–7.9) 5.7 (3.1–7.1) CNS time to response, median (range), months 1.4 (0.9–8.5) 1.3 (1.1–2.8) 1.4 (0.9–8.5) 1.3 (0.9–3.0) Conclusions I-DXd demonstrated encouraging CNS activity in pts with ES-SCLC and BL BM regardless of prior RT for BL BM. The safety profile was manageable, similar between pts with and without BL BM, and consistent with the overall 12 mg/kg..."

Clinical • Brain Cancer • CNS Tumor • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

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. (ASCO 2025) - P1/2 | "KEYMAKER-U01 substudy 01A (NCT04165070) is a phase 1/2, two-part, rolling arm, open-label study assessing the efficacy and safety of pembrolizumab plus an investigational agent (part A: vibostolimab, boserolimab, MK-4830, and MK-0482; part B: I-DXd and HER3-DXd), with or without chemotherapy in untreated stage IV NSCLC...In Arms 5 and 6, participants will receive I-DXd plus pembrolizumab 200 mg Q3W (Arm 5) or I-DXd plus pembrolizumab with 4 cycles of carboplatin area under the curve 5 or 6 mg/ml/min (Arm 6); I-DXd dose will be at 8mg/kg...The primary endpoint is incidence of dose-limiting toxicities until the start of cycle 2, and AEs and treatment discontinuations due to AEs until 40 days after last treatment (90 days for serious AEs); secondary endpoints include ORR and DOR, both per RECIST v1.1 by BICR, and pharmacokinetic parameters, including maximum concentration (Cmax) and maximum trough concentration (Ctrough) of I-DXd and HER3-DXd. Enrollment will be..."

IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ERBB3 • HER-2 • ROS1

Targeting B7-H3 in the small cell lung carcinoma (SCLC) tumor-immune microenvironment (TIME) (AACR 2026) - P2 | "Therapeutic strategies targeting B7-H3 using the antibody-drug conjugate (ADC), ifinatamab deruxtecan (I-DXd), has shown recent promise in SCLC... Our study suggests that B7-H3 expression is heterogenous in SCLC and may differ by immunologic subtype. Moreover, our findings suggest that B7-H3 may serve as a target on stromal components of the SCLC TIME. Our results suggest that in addition to the direct targeting of tumor cells, a potential mechanism of action underlying the efficacy of I-DXd may be an increase in vascular permeability."

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Improving the efficacy of B7-H3 targeting antibody-drug conjugates in TP53-deficient prostate cancer (AACR 2026) - "Our studies will accelerate the development of effective therapies for prostate cancer patients with TP53 defects and provide a strong rationale for using TP53 status as a molecular biomarker to guide patient selection for clinical application of DS-7300a. This novel biomarker-driven combination strategy will also provide insights into the clinical trial design of Dxd-based ADCs and ferroptosis inducers in advanced prostate cancer and other malignancies."

ADC • Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276 • GPX4 • TP53

Ex vivo micro-tumor testing platform to guide patient stratification for clinical development of ADCs (AACR 2026) - "This study evaluates ex vivo sensitivity to clinically relevant ADCs in ovarian (OC), non-small cell lung (NSCLC), and colorectal (CRC) cancer, aiming to identify predictive biomarkers and guide patient stratification to optimize clinical benefit.Materials and Methods Ex vivo evaluation of patient specific responses to ADCs was performed by testing mirvetuximab-soravtansine (MIRV) in OC patient samples (N=25), ifinatamab deruxtecan (IFI) in CRC patient samples (N=5) and telisotuzumab vedotin (TEL) in NSCLC patient samples (N=10)...A strong correlation was observed between MIRV and paclitaxel sensitivity (R = 0.86), both of which target tubulin. A reduced correlation was observed for MIRV and carboplatin (R = 0.59), that acts by crosslinking DNA...The platform is future-ready, offering multimodal capabilities including tumor microenvironment (TME) characterization, target protein profiling capturing patient heterogeneity, and assessment of bystander and synergistic..."

ADC • Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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) (clinicaltrials.gov) - P1/2 | N=262 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=59 ➔ 262

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Antibodies to watch in 2026. (PubMed, MAbs) - "In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab...Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by..."

Journal • Review • Oncology

IDeate-Prostate02: A PHASE 1/2, OPEN-LABEL UMBRELLA SUBSTUDY OF IFINATAMAB DERUXTECAN-BASED TREATMENT COMBINATIONS OR AS MONOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P1/2 | "Two monotherapy arms (Arm 1 [docetaxel] and Arm 2 [I-DXd]) will enroll participants into the Efficacy Phase, and 2 I-DXd combination arms (Arm 3: I-DXd+MK-5684; and Arm 4: I-DXd+ARPI [abiraterone acetate or enzalutamide; prior treatment dependent]) will enroll into the Safety Lead-in, followed by Efficacy Phase. Recruitment is ongoing. "

Clinical • Metastases • Monotherapy • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

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) (clinicaltrials.gov) - P1/2 | N=59 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=40 ➔ 59

Enrollment change • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Daiichi Sankyo gears up for five ADC launches in 2026 (pharmaphorum) - "The launches are mostly new indications for Enhertu and Datroway (datopotamab deruxtecan). But one is a novel ADC. They are: (i) Enhertu combined with pertuzumab in HER-2 positive advanced or metastatic breast cancer, which was approved in December; (ii) Enhertu in early-stage breast cancer, which has a May PDUFA date; (iii) Enhertu in the post-neoadjuvant setting, expected in the summer; (iv) Datroway in triple negative breast cancer, also expected in the summer; (v) Ifinatamab deruxtecan (I-DXd) in small cell lung cancer, being developed in partnership with MSD..."

Launch • HER2 Positive Breast Cancer • Small Cell Lung Cancer • Triple Negative Breast Cancer

AN INDIRECT TREATMENT COMPARISON (ITC) OF IFINATAMAB DERUXTECAN (I-DXD) VERSUS REAL-WORLD PHYSICIAN'S CHOICE OF THERAPY (RWPCT) IN PATIENTS PREVIOUSLY TREATED WITH AT LEAST 2 LINES OF THERAPY (LOTS) FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER... (ISPOR 2026) - P2 | "The real-world cohort (n=297) included adults with ES-SCLC who initiated first-line rwPCT in/after January 2018 and received third-line or fourth-line rwPCT (chemotherapy [including lurbinectedin], anti-PD-[L]1, or chemotherapy + anti-PD-[L]1) in/before June 2023. I-DXd demonstrated longer OS, PFS, and TTD than rwPCT in this ITC, supporting its potential as a promising treatment option for patients with previously treated ES-SCLC."

Clinical • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

IDeate-Prostate01: A phase 3, randomized, open-label study of ifinatamab deruxtecan versus docetaxel in participants with previously treated metastatic castration-resistant prostate cancer. (ASCO-GU 2026) - P3 | "Recruitment is ongoing. Previously presented at 26th Annual Meeting of the Society of Urologic Oncology; December 2–5, 2025; Phoenix, AZ."

Clinical • First-in-human • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

IDeate-Lung02: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Daiichi Sankyo | Active, not recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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) (clinicaltrials.gov) - P1/2 | N=242 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2029 ➔ Feb 2030

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov) - P1/2 | N=232 | Active, not recruiting | Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3