samatatug zovodotin (XB002) / Exelixis - LARVOL DELTA

Study of XB002 in Subjects With Solid Tumors (JEWEL-101) (clinicaltrials.gov) - P1 | N=269 | Completed | Sponsor: Exelixis | Active, not recruiting ➔ Completed

Platinum resistant • Trial completion • Breast Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ER • HER-2 • PGR

Preclinical characterization of XB002, an anti-tissue factor antibody-drug conjugate for the treatment of solid tumors. (PubMed, Mol Cancer Ther) - "In non-human primate models, XB002 showed exposure in the desired range and no evidence of bleeding or neutropenia. Taken together, these data demonstrate potential anti-tumor activity across a spectrum of oncology indications and strongly support its clinical development."

Journal • Preclinical • Bladder Cancer • Head and Neck Cancer • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of XB002 in Subjects With Solid Tumors (JEWEL-101) (clinicaltrials.gov) - P1 | N=573 | Active, not recruiting | Sponsor: Exelixis | Trial completion date: Feb 2025 ➔ Jul 2025

Combination therapy • Metastases • Trial completion date • Breast Cancer • Castration-Resistant Prostate Cancer • Cervical Cancer • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ER • HER-2 • PGR

Study of XB002 in Subjects With Solid Tumors (JEWEL-101) (clinicaltrials.gov) - P1 | N=573 | Active, not recruiting | Sponsor: Exelixis | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Feb 2025 | Trial primary completion date: Jun 2024 ➔ Feb 2025

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ER • HER-2 • PGR

Exelixis Announces Second Quarter 2024 Financial Results and Provides Corporate Update (Businesswire) - "...Exelixis announced it will discontinue the development of XB002, the company’s tissue factor (TF)-targeting ADC, as part of its portfolio prioritization efforts. Based on available data, the compound is unlikely to improve upon tisotumab vedotin or other competitor TF-targeting ADCs currently in development. The company plans to disclose data from the phase 1 JEWEL-101 study, evaluating XB002 in advanced solid tumors, at a later date."

Discontinued • P1 data • Solid Tumor

Phase I study of the tissue factor-targeting antibody-drug conjugate XB002 among patients with advanced solid tumors (JEWEL-101): Design of expansion cohorts for endometrial, epithelial ovarian, and cervical cancers (SGO 2024) - P1 | "A dose-escalation stage will determine the maximum tolerated/recommended doses of XB002 alone and in combination with nivolumab or bevacizumab, and a cohort expansion stage will assess safety and antitumor activity in tumor-specific cohorts. Secondary objectives include safety, pharmacokinetics, immunogenicity, progression-free survival, duration of response, and overall survival. Enrollment is ongoing in the US, Europe, and the Asia-Pacific region."

Clinical • Metastases • P1 data • Cervical Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor

Phase 1 Study of the Tissue Factor–Targeting Antibody-Drug Conjugate XB002 in Patients With Advanced Solid Tumors (JEWEL-101): Design of Expansion Cohorts for Squamous Cell Carcinoma of the Head and Neck (MHNCS 2024) - P1 | "The maximum tolerated and/or recommended doses of XB002 alone and in combination with nivolumab or bevacizumab will be determined in a dose-escalation stage. TBD"

Clinical • IO biomarker • Metastases • P1 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Ophthalmology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cohort expansion from the phase 1 JEWEL-101 study investigating the tissue factor-targeting antibody-drug conjugate XB002 in patients with advanced solid tumors: Pancreatic and esophageal cancer cohorts. (ASCO-GI 2024) - P1 | "JEWEL-101 (NCT04925284) is a phase 1, dose-escalation and multi-cohort expansion study evaluating XB002 alone and in combination with nivolumab or bevacizumab in pts with advanced solid tumors. ENA 2022. Clinical trial information: NCT04925284."

Clinical • Metastases • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Cohort expansion from the phase 1 JEWEL-101 study investigating the tissue factor–targeting antibody-drug conjugate XB002 in patients with advanced solid tumors: Metastatic castration-resistant prostate cancer cohort. (ASCO-GU 2024) - P1 | "ENA 2022. Clinical trial information: NCT04925284."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I expansion study of the tissue factor (TF)–targeting antibody-drug conjugate (ADC) XB002 as a single-agent and combination therapy in patients with advanced solid tumors (JEWEL-101) (ESMO Asia 2023) - P1 | "JEWEL-101 (NCT04925284) is a multicenter, phase 1 first-in-human trial, designed to determine the recommended dose and/or maximum tolerated dose of XB002 alone or in combination with nivolumab or bevacizumab and evaluate safety and antitumor activity in advanced solid tumors. Secondary objectives include safety, PK, immunogenicity, PFS, DOR, and OS. Enrollment is ongoing in the US, Europe, and Asia-Pacific region."

Clinical • Combination therapy • Metastases • P1 data • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Phase 1 study of the tissue factor-targeting antibody-drug conjugate XB002 in patients with advanced solid tumors (JEWEL-101): Design of the triple-negative and hormone receptor-positive breast cancer expansion cohorts (SABCS 2023) - P1 | "Enrollment is planned across sites in the US, Europe, and Asia-Pacific. Contact information: Exelixis Clinical Trials, druginfo@exelixis.com, 1-888-393-5494"

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 in subjects with inoperable locally advanced or metastatic solid tumors (SGO 2022) - No abstract available

Clinical • PK/PD data • Oncology • Solid Tumor

A Phase 1 study of the anti-tissue factor antibody-drug conjugate XB002 in patients with advanced solid tumors (JEWEL-101): initial results from the dose-escalation stage (AACR-NCI-EORTC 2022) - P1 | "XB002 Q3W was well tolerated at multiple dose levels with manageable TRAEs, all grade ≤2 including ocular toxicities, and no bleeding events or neuropathy. PK analysis revealed appropriate exposure with very low levels of free payload. Dose-escalation is ongoing and updated data will be presented."

Clinical • P1 data • Oncology • Solid 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 2023, Exelixis plans to expand the phase 3 development program for zanzalintinib (XL092) with multiple new phase 3 pivotal trial initiations of zanzalintinib in combination with several immuno-oncology (IO) therapies....In 2023, Exelixis intends to accelerate the development of XB002, its next-generation tissue factor-targeting ADC, both as a monotherapy and in combination with IO and other targeted therapies, across a wide range of tumor types....Anticipated tumor cohorts across the trial include forms of non-small cell lung, ovarian, cervical, urothelial, squamous cell head and neck, pancreatic, esophageal, prostate, and breast."

New P3 trial • Trial status • Cervical Cancer • Esophageal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

A Phase 1 Study of the Antitissue Factor ADC XB002 in Patients With Advanced Solid Tumours: Initial Results From the Dose-Escalation Stage (ADC London 2023) - "• Explore how XB002 is a novel antibody-drug conjugate (ADC) composed of a high-affinity tissue factor (TF)-directed human monoclonal antibody conjugated to an auristatin-based payload, ZymeLink™ Auristatin (ZLA) • Learn how XB002 infusion Q3W was well tolerated at five escalating dose levels with manageable toxicity and is ongoing"

Clinical • Metastases • P1 data • Oncology • Solid Tumor

A first-in-human phase 1 study of the safety and pharmacokinetics of XB002 in patients with inoperable locally advanced or metastatic solid tumors (AACR 2022) - P1 | "The primary endpoint for cohort expansion is objective response rate per RECIST v1.1 by investigator. Additional endpoints include safety/tolerability, XB002 pharmacokinetics and immunogenicity, duration of response and PFS per RECIST v1.1 by investigator, overall survival, and changes in tumor markers from baseline."

Clinical • P1 data • PK/PD data • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Exelixis Announces Promising Initial Dose-Escalation Results from the First-in-Human Phase 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors at ENA 2022 (Businesswire) - P1 | N=451 | JEWEL-101 (NCT04925284) | Sponsor: Exelixis | "JEWEL-101 is enrolling patients with advanced solid tumors for which therapies are unavailable, ineffective or intolerable...A pharmacokinetic analysis demonstrated that XB002 exposure increased more than or proportionately to a dose increase from 0.16 mg/kg to 2.0 mg/kg. XB002 total antibody and intact antibody-drug conjugate pharmacokinetics were similar, suggesting XB002 is stable after infusion. Levels of free payload remained low (<1 ng/mL) at all dose levels. At 2.0 mg/kg, mean AUC0-t was 121 μg∙day/mL for intact antibody-drug conjugate and 4.21 ng∙day/mL for free payload; mean Cmax was 46.6 μg/mL and 0.809 ng/mL, respectively...No objective responses were observed."

P1 data • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Exelixis Announces Second Quarter 2022 Financial Results and Provides Corporate Update (Businesswire) - "...'Moving into the second half of this year, we have much to look forward to, including the potential to further augment the CABOMETYX label through upcoming clinical data readouts expected from the CONTACT-01 and CONTACT-03 pivotal studies in non-small cell lung cancer and renal cell carcinoma, respectively, as well as anticipated clinical updates from our XL092, XB002 and XL102 pipeline programs'."

Clinical data • P3 data • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Thoracic Cancer • Urothelial Cancer

Study of XB002 in Subjects With Solid Tumors (JEWEL-101) (clinicaltrials.gov) - P1 | N=451 | Recruiting | Sponsor: Exelixis | N=199 ➔ 451

Combination therapy • Enrollment change • Breast Cancer • Cervical Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • ER • HER-2 • PGR

XB002: Model-Based Dose Selection for a Novel Anti-Tissue Factor ADC With a ZLA Payload for the Treatment of Solid Tumours (ADC London 2022) - "Review how efficacy data from Pharmacology tumour models in mice and PK data from monkeys were used to predict XB002 human PK and estimate human efficacious dose Understand how nonclinical safety in cynomolgus monkeys demonstrated adequate safety margins for the range of doses explored in the FTIH study Assess how the PK model was fitted to the human PK from the FTIH dose escalation phase to refine dose predictions"

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) - "Anticipated Pipeline Milestones: (i) Expansion of the XL092 STELLAR-001/-002 clinical program: Exelixis expects to expand the ongoing phase 1b STELLAR-001 and STELLAR-002 studies, which are evaluating XL092 in combination with several IO therapies, into potential new tumor types, and IO and other targeted therapy combination regimens throughout 2022. Clinical updates from these trials are expected in 2022; (ii) Acceleration of the XB002 clinical program: The single-agent dose escalation cohort for the ongoing phase 1 trial of XB002 continues enrolling, and the study is expected to move into its cohort expansion and combination phase shortly....Exelixis expects to provide clinical updates and present data from the ongoing phase 1 study of XB002 in 2022."

Clinical protocol • P1 data • Breast Cancer • Cervical Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Exelixis and Iconic Therapeutics Amend Option and License Agreement for XB002, an Antibody-Drug Conjugate Targeting Tissue Factor (Businesswire) - "Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics...announced that the companies have amended the terms of their May 2019 exclusive option and license agreement for XB002 (formerly ICON-2), a next-generation tissue factor (TF)-targeting antibody-drug conjugate (ADC). Under the amended agreement announced today, Exelixis has acquired broad rights to use the anti-TF antibody incorporated into XB002, for any application, including conjugated to other payloads, as well as rights within oncology to a number of other anti-TF antibodies developed by Iconic, including for use in ADCs and multi-specific biologics....'We look forward to sharing initial data from the ongoing XB002 phase 1 clinical trial this year'."

Licensing / partnership • P1 data • Oncology • Solid Tumor

[VIRTUAL] Discussing XB002, a Tissue- Factor-Targeted Antibody Drug Conjugate for the Treatment of Solid Tumors (ADC-USA 2021) - "XB002 is an ADC designed to improve on the therapeutic potential of ADCs that target TF XB002 is a high affinity ADC with the Zymelink Aurastatin linkerpayload Presenting efficacy, tolerability and exposure of XB002 in preclinical studies"

Oncology • Solid Tumor

Study of XB002 in Subjects With Solid Tumors (clinicaltrials.gov) - P1; N=199; Recruiting; Sponsor: Exelixis

New P1 trial • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer