XB010 / Exelixis - LARVOL DELTA

A first-in-human, phase I study of XB010, a 5T4-MMAE ADC, in patients with non-small cell lung cancer (NSCLC) and other solid tumors (ELCC 2026) - P1 | "Here, we describe the design of XB010-101, a first-in-human study of XB010.Trial design XB010-101 (NCT06545331) is a phase I study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors for whom alternative therapies do not exist, are intolerable, or are no longer effective. Safety will be assessed via the incidence of adverse events (AEs) and serious AEs. Preliminary antitumor activity of XB010 will be evaluated by objective response rate assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1."

ADC • Clinical • First-in-human • IO biomarker • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TPBG

A First-in-Human, Phase 1 Study of XB010, a 5T4-MMAE ADC, in Patients With Advanced Breast Cancer and Other Solid Tumors (ESMO-BC 2026) - No abstract available

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor

Anticipated R&D Milestones: Progress of Phase 1 Clinical Programs for XL309, XB010, XB628 and XB371 (Businesswire) - "Exelixis is advancing ongoing phase 1 clinical trials for XL309 (USP1 inhibitor), XB010 (5T4-targeting ADC), XB628 (PD-L1 + NKG2A bispecific) and XB371 (TF-targeting ADC). If phase 1 data are supportive, Exelixis plans to progress these molecules into full development...."

Trial status • Solid Tumor

Preclinical characterization of XB010: a novel antibody-drug conjugate for the treatment of solid tumors that targets tumor-associated antigen 5T4. (PubMed, Mol Cancer Ther) - "XB010 is a novel anti-5T4 ADC that exhibits potent anti-tumor activity, inhibiting cancer cell growth in vitro and tumor growth in various in vivo models, with an acceptable toxicity profile. These findings support the evaluation of XB010 in clinical studies."

Journal • Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TPBG

Exelixis Announces Preliminary Fiscal Year 2024 Financial Results, Provides 2025 Financial Guidance and Outlines Key Priorities and Milestones for 2025 (Businesswire) - "Progress of Phase 1 Clinical Trials for XB010 and XL495. Exelixis initiated clinical development of its XB010 and XL495 pipeline programs in 2024....The first-in-human, global phase 1 trial of XB010 is evaluating the compound in patients with locally advanced or metastatic solid tumors. The dose-escalation stage of the study is evaluating XB010 as a single agent and in combination with pembrolizumab to inform the cohort-expansion stage....The first-in-human phase 1 clinical trial of XL495 is evaluating the compound in patients with advanced solid tumors; the dose-escalation stage of the study is designed to determine the maximum tolerated dose of XL495....Exelixis plans to present preclinical data from the XL495 program at a scientific meeting in 2025."

P1 data • Trial status • Solid Tumor

Study of XB010 in Subjects With Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: Exelixis

Combination therapy • Metastases • New P1 trial • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Exelixis Announces Second Quarter 2024 Financial Results and Provides Corporate Update (Businesswire) - "...Exelixis announced that enrollment has been completed in the STELLAR-303 phase 3 pivotal study. STELLAR-303 is evaluating zanzalintinib in combination with atezolizumab compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient....Exelixis anticipates preliminary results from the study to readout in 2025. Additionally, Exelixis intends to initiate a new phase 3 pivotal trial, STELLAR-311, evaluating zanzalintinib compared with everolimus as a first oral therapy in patients with pNET and epNET, in the first half of 2025....Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors."

Enrollment closed • New P3 trial • P3 data • Trial status • Colorectal Cancer • Neuroendocrine Tumor

Exelixis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (Businesswire) - "acceleration of the XB002 clinical program into full development by year-end; advancement of the XL102 QUARTZ-101 phase 1 study into the tumor-specific cohort-expansion stage and in planned combination cohorts; in collaboration with partner Cybrexa, progression of phase 1 clinical study for CBX-12, including dose-expansion cohorts; expected IND filing for ADU-1805 in the first quarter of 2023 by partner Sairopa; advancement of DCs XB010, XB014 and XB628 toward IND filings."

Clinical • Clinical protocol • IND • New P1 trial • Oncology • Solid Tumor

Exelixis Announces Preliminary Fourth Quarter and Full Year 2022 Financial Results, Provides 2023 Financial Guidance, and Outlines Key Priorities and Milestones for 2023 (Businesswire) - "In the first quarter of 2023, Exelixis expects its partner Sairopa to file an IND for ADU-1805, a potential best-in-class monoclonal antibody targeting SIRPα to block the SIRPα–CD47 checkpoint....In 2023, Exelixis plans to advance XB010, the first custom ADC generated through the company’s biotherapeutics network of collaborations, and XB014, the company’s first bispecific antibody designated as a DC in August 2022, through preclinical development and IND-enabling studies, toward potential IND filings in early 2024.... Exelixis announced it has designated XB628 as its latest DC and plans to advance the program through preclinical development in 2023, toward a potential IND filing in 2024."

IND • Oncology • Solid Tumor

Exelixis Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results, Provides 2022 Financial Guidance, and Outlines Key Priorities and Milestones for 2022 (Businesswire) - "Potential new development candidates:...With respect to biotherapeutics, these include XB010, the first custom ADC generated through the company’s collaboration network, which was designated a development candidate in late 2021 and will enter preclinical development shortly....Additional ADCs advancing through discovery target a range of tumor antigens including AMHR2, ROR1/2, TF and DLL3 and utilize a variety of conjugation technologies and payloads. In addition, Exelixis is advancing two bispecific programs through its Invenra collaboration that combine a PD-L1 targeting arm with either a CD47 targeting arm to block a macrophage checkpoint, or an NKG2A targeting arm to promote NK cell activation in the tumor microenvironment."

Pipeline update • Oncology