tusamitamab sonditecan (PF-08046050) / Sanofi, Pfizer - LARVOL DELTA

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=914 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Suspended ➔ Recruiting | N=175 ➔ 914

Enrollment change • Enrollment open • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Small Cell Lung Cancer • Solid Tumor

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=165 | Suspended | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Recruiting ➔ Suspended

Trial suspension • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Small Cell Lung Cancer • Solid Tumor • CEACAM5

SGN-CEACAM5C / SAR445953, a novel topoisomerase I inhibitor antibody-drug conjugate targeting CEACAM5, has potent anti-tumor activity in CRC, PDAC, GC and lung cancer tumor models (AACR 2024) - P1 | "In CRC, gastric and lung cancer SMT, disease control rates are 95%, 84% and 87%, respectively with overall response rates of 55%, 68% and 71% including 15%, 10% and 26% of complete responses, respectively. The high anti-tumor activity across panels of PDX models of several CEACAM5 positive indications supports further evaluation of SGN-CEACAM5C / SAR445953 in patients with CRC, PDAC, GC and lung cancers (NCT06131840)."

ADC • Preclinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CEACAM5

An open-label phase 1 study to investigate SGN-CEACAM5C in adults with advanced solid tumors (SGNCEA5C-001, Trial in Progress) (AACR 2024) - P1 | "Safety and antitumor activity endpoints will be summarized using descriptive statistics. Recruitment is ongoing for Part A in North America."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Small Cell Lung Cancer • Solid Tumor • CEACAM5

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=914 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | N=494 ➔ 914

Enrollment change • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=494 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: May 2030 ➔ Sep 2030

Trial completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=410 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Mar 2030 ➔ Dec 2029 | Trial primary completion date: Mar 2030 ➔ Jun 2029

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

SGNCEA5C-001: A Study of PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=410 | Recruiting | Sponsor: Seagen Inc. | Trial primary completion date: Mar 2029 ➔ Mar 2030

Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

An open-label phase 1 study to investigate SGNCEACAM5C/SAR445953 in adults with advanced solid tumors (SGNCEA5C-001). (ASCO 2024) - P1 | "5. Baudat 2024."

Clinical • Metastases • P1 data • Colorectal Cancer • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Small Cell Lung Cancer • Solid Tumor • CEACAM5

Delving into SGN-CEACAM5C, an ADC With Novel TOP1 Drug Linker With Outstanding Preclinical Activity (ADC London 2024) - "Synopsis SGN-CEACAM5C is an ADC with a potent topoisomerase I payload with distinct properties SGN-CEACAM5C has outstanding preclinical activity"

Preclinical • CEACAM5 • TOP1

SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=410 | Recruiting | Sponsor: Seagen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=410 | Not yet recruiting | Sponsor: Seagen Inc.

Metastases • New P1 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Seagen Third Quarter 2023 Financial Results Reflect Strong Product Sales Growth, and Significant Portfolio and Pipeline Progress (Seagen Press Release) - "The Company expects to initiate a phase 3 trial for SGN-B6A, a novel, vedotin ADC targeting integrin beta-6, as a monotherapy in previously treated patients with NSCLC before the end of 2023....The Company initiated a phase 1 trial for SGN-EGFRd2, a gamma delta bispecific T-cell engager for EGFR-expressing solid tumors. Year to date, the Company has submitted INDs for three novel targeted cancer therapies, including SGN-EGFRd2, SGN-35T and SGN-CEACAM5C, with the goal of submitting one additional IND before year end."

IND • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer : Episode 1 - COMING SOON: CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer (Targeted Oncology) - "...provides a look at an upcoming Targeted Oncology Precision Medicine in Oncology program that will discuss the role of CEACAM5 in the growth and progression of NSCLC, including the mechanism of action, current safety and efficacy data, and results from recent trials."

Video

CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer : Episode 1; Overview of the NSCLC Landscape, Prognosis, and Biomarker-Driven Treatments (Targeted Oncology) - "A comprehensive overview of the current landscape of non-small cell lung cancer (NSCLC), highlighting the impact of biomarkers on treatment selection."

Biomarker • Video

CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer : Episode 3: CEACAM5: Role, Expression, and Therapeutic Potential in NSCLC (Targeted Oncology) - "The role of CEACAM5, its expression in NSCLC, and its potential as a therapeutic target are thoroughly examined, including its impact on tumorigenesis and prognosis in NSCLC patients."

Video

CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer : Episode 2: Emerging Biomarkers and Targeted Therapies in NSCLC (Targeted Oncology) - "The discussion centered around emergent biomarkers and targeted therapies in NSCLC, exploring targets like CEACAM5, TROP2, HER3, cMET, and the potential role of antibody drug conjugates in refractory disease."

Biomarker • Video

CEACAM5: An Emerging Therapeutic Target in Non-small Cell Lung Cancer : Episode 4: CEACAM5 Testing in Clinical Practice (Targeted Oncology) - "Experts share their approach to CEACAM5 testing, including the testing procedure, patient selection criteria, and timing of testing."

Video

Seagen to Present New Clinical and Preclinical Data From Broad Portfolio of Targeted Cancer Therapeutics at the 2023 AACR Annual Meeting (Seagen Press Release) - "Seagen will also present new preclinical findings on the antitumor activity of disitamab vedotin, an ADC that targets cancers expressing HER2, as a monotherapy and in combination with tucatinib in breast and gastric cancer models, and on SGN-B6A, a wholly-owned, first-in-class vedotin ADC that targets integrin beta-6, which is highly expressed in a range of solid tumors. Seagen and Sanofi will also unveil the first preclinical data from a novel topoisomerase I inhibitor ADC targeting CEACAM5, showing potent antitumor activity in patient-derived colorectal cancer models."

Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor