IDE849 / Jiangsu Hengrui Pharma, Ideaya Biosci - LARVOL DELTA

IDE849, a delta-like ligand 3 (DLL3)-targeted topoisomerase I (TOPI) antibody–drug conjugate in advanced solid tumors (ESMO 2026) - No abstract available

ADC • Metastases • Oncology • Solid Tumor • DLL3 • TOP1

SHR-4849 (IDE849), an ADC targeting delta-like ligand 3 (DLL3), in relapsed small cell lung carcinoma (SCLC) and other neuroendocrine carcinomas (NECs): long-term results from the phase 1 study (ESMO 2026) - No abstract available

ADC • P1 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A First-In-Human Phase 1 Study of SHR-4849 (IDE849), a DLL3-Directed Antibody-Drug Conjugate, in Relapsed SCLC (IASLC-WCLC 2025) - P1 | "Conclusions : SHR-4849 (IDE849) demonstrated manageable safety and preliminary anti-tumor activity in relapsed SCLC. Dose expansion is ongoing to determine RP2D."

First-in-human • P1 data • Anemia • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Small Cell Lung Cancer • Solid Tumor • DLL3

Clinical data updates for IDE849 in 100 ES-SCLC and NEC patients by partner Hengrui at ESMO 2026 and the IDEAYA sponsored Phase 1/2 clinical trial in ES-SCLC and NEC in Q4 2026 to support a potential best-in-class profile. (PRNewswire)

New P1/2 trial • P1 data • Neuroendocrine Carcinoma • Small Cell Lung Cancer

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer (PRNewswire) - "Based on FDA Type C meeting, targeting to initiate a randomized Phase 3 registrational trial for IDE849 monotherapy by year-end 2026 in ES-SCLC, with ORR by BICR as the primary endpoint for potential accelerated approval and median OS as the primary endpoint for potential full approval."

FDA event • New P3 trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Selected Pipeline Developments and Corporate Updates: ADC / DDR combinations (PRNewswire) - "IDE849 (DLL3 TOP1 ADC): IDEAYA's partner in China, Jiangsu Hengrui Pharmaceuticals (Hengrui), plans to provide a clinical data update from their ongoing Phase 1 trial in SCLC and NEC at ESMO....IDEAYA also plans to provide the first clinical data from its ongoing global Phase 1/2 trial of IDE849 in SCLC and NEC in the second half of 2026. IDEAYA is having discussions with the FDA to align on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC and plans to provide more detail on the proposed trial design with its data update in the second half of the year, with the goal of initiating the registrational trial by the end of 2026. Hengrui is also targeting to initiate a Phase 3 registrational trial for IDE849 in refractory SCLC in China by the end of 2026."

New P3 trial • P1 data • P1/2 data • Neuroendocrine Carcinoma • Small Cell Lung Cancer

IDEAYA Biosciences Announces ESMO 2026 Presentations for Darovasertib and IDE849 Clinical Programs (PRNewswire) - "The presentations will feature data updates from across IDEAYA's clinical pipeline, including multiple ongoing trials of darovasertib in uveal melanoma, including the registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic UM (mUM), the Phase 2 OptimUM-01 trial in HLA*A2:01-positive mUM, and the Phase 2 OptimUM-09 trial in the neoadjuvant setting of primary uveal melanoma. IDEAYA's partner, Hengrui Pharma, will also present clinical trial results from their Phase 1 study of IDE849 (SHR-4849) being conducted in China in patients with small cell lung carcinoma (SCLC) and other neuroendocrine carcinomas (NECs)."

P1 data • P2 data • P2/3 data • Neuroendocrine Carcinoma • Small Cell Lung Cancer • Uveal Melanoma

IDEAYA's China-region partner, Jinagsu Hengrui Pharmaceuticals Co. Ltd., is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and provide a clinical update from their Phase 1 trial in SCLC and NEC at a medical conference in the second half of 2026. (IDEAYA Biosciences Press Release)

New P3 trial • P1 data • Neuroendocrine Carcinoma • Small Cell Lung Cancer

IDE849 (DLL3 TOP1 ADC): targeting to provide a clinical data update from the ongoing IDEAYA-sponsored global Phase 1/2 trial of IDE849 in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) by the end of 2026. (IDEAYA Biosciences Press Release) - "The company is planning to initiate a monotherapy registrational trial by the end of 2026...Achieved first-patient-in (FPI) in Phase 1 combination trial of IDE849 and IDE161, IDEAYA's proprietary inhibitor of poly(ADP-ribose) glycohydrolase (PARG)."

New trial • P1/2 data • Trial status • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Ideaya Biosciences announces clinical collaboration with AstraZeneca for lung cancer study (Investing.com) - "According to a statement in the SEC filing, Ideaya will sponsor the clinical combination study, while AstraZeneca will supply Imfinzi, a programmed death-ligand 1 (PD-L1) inhibitor."

Licensing / partnership • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Multicenter, open-access Phase II clinical study of SHR-4849 injection combined with other anti-tumor drugs in patients with malignant solid tumors (ChiCTR) - P2 | N=120 | Sponsor: Shandong Cancer Hospital; Suzhou Shengdiya Biomedical Co., LTD

New P2 trial • Lung Cancer • Oncology • Solid Tumor • DLL3

HRA00130-C004, a novel anti-DLL3 ADC with bystander effect, high DAR and favorable safety profiles (AACR 2024) - "Ther. Oncolytics, 2021, 20, 470; 4.Journal of Cancer, 2022, 13, 2945; 5.Cellular Oncology, 2019, 42, 261; 6.Journal of Hematology and Oncology 2019, 12, 61;"

ADC • Clinical • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

IDEAYA Biosciences Announces First-Patient-In for Phase 1 Combination Study of IDE849, DLL3 TOP1 ADC, and IDE161, PARG Inhibitor, in DLL3 Upregulated Solid Tumor Indications, including SCLC, NETs, NECs, and Melanoma (PRNewswire) - "The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia....Targeting IDE849 monotherapy, and IDE849 and IDE161 combination clinical data update in H2 2026."

P1 data • Trial status • Melanoma • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Small Cell Lung Cancer

Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations (PRNewswire) - "IDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026; IDE034 (B7H3/PTK7 bispecific TOP1 ADC)...expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26; Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies."

Financing • New P1 trial • P1 data • Trial status • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Neuroendocrine Carcinoma • Ovarian Cancer • Small Cell Lung Cancer

IDE849: “IDE849 (SHR-4849) demonstrated compelling initial efficacy in SCLC”; Small cell lung cancer (44th Annual J.P. Morgan Healthcare Conference, IDEAYA Biosciences)

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

IDE849: “IDE849 (SHR-4849) demonstrated compelling initial efficacy in SCLC”; Small cell lung cancer (44th Annual J.P. Morgan Healthcare Conference, IDEAYA Biosciences)

P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

2026 Corporate Objectives:…Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations (PRNewswire) - "(i) IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026; (ii) IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 '26; (iii) IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26."

New trial • Neuroendocrine Carcinoma • Small Cell Lung Cancer

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=208 | Recruiting | Sponsor: IDEAYA Biosciences | N=90 ➔ 208

Enrollment change • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P2 trial • Oncology • Solid Tumor

IDE849 (DLL3 TOP1i ADC) (PRNewswire) - "The company continues to enroll SCLC patients with plans to expand into patients with neuroendocrine tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025."

Enrollment status • Neuroendocrine Tumor • Small Cell Lung Cancer

IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. (PRNewswire)

New P1 trial • Solid Tumor

Hengrui Pharma (600276.SH) announced that its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd., have received the ’Clinical Trial Approval Notice’ (FUTU) - "...issued by the National Medical Products Administration for SHR-7787 Injection, SHR-4849 Injection, Bevacizumab Injection, and Adebrelimab Injection."

New trial • Solid Tumor

A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: IDEAYA Biosciences

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor