CX-904 / CytomX, Amgen - LARVOL DELTA

CTMX-904-101: A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Terminated | Sponsor: CytomX Therapeutics | Active, not recruiting ➔ Terminated; Sponsor Decision

Trial termination • Oncology • Solid Tumor

CTMX-904-101: A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=83 | Active, not recruiting | Sponsor: CytomX Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

CytomX Therapeutics Announces 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Program Updates:...CX-904 (EGFR-CD3 PROBODY TCE): Based on CX-904 clinical observations to-date as well as CytomX pipeline priorities, CytomX and Amgen have jointly decided to not further develop CX-904."

Discontinued • Solid Tumor

CytomX Therapeutics Announces 2025 Strategic Pipeline Priorities and Provides Corporate Update (GlobeNewswire) - "Clinical Program Updates and 2025 Milestones:...CX-904 (PROBODY T-cell-engager (TCE) Targeting EGFRxCD3): The Phase 1 study of CX-904 has enrolled over 70 patients to date. The 15 mg target step-dose level has been cleared and the maximum tolerated dose has not been reached. Based on ongoing clinical observations, including evaluation of safety and anti-tumor activity across multiple EGFR positive tumor types, enrollment in 2025 will prioritize escalation to higher dose levels. Plans for Phase 1a completion and potential advancement to Phase 1b are pending ongoing consideration of 2025 program resourcing given CytomX current capital constraints and discussions with our partner Amgen."

Trial status • Solid Tumor

CytomX Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Third Quarter Business Highlights and Recent Developments:...(i) CX-904:...CX-904 has now cleared the 15 mg target dose level, utilizing a step-dose schedule. Dose escalation and optimization continue in pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma, and non-small cell lung cancer. A maximum tolerated dose for step-dosing has not yet been reached. Potential Phase 1b initiation in one or more tumor types is anticipated in 2025 pending the selection of an optimized dose and schedule and alignment with our global development partner, Amgen."

Trial status • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities and Key Milestones: (i) CX-904 (EGFRxCD3): Continued Phase 1a dose escalation in PDAC, HNSCC and NSCLC focused on the selection of recommended Phase 1b dose(s); A CX-904 Phase 1 program update is expected by the end of 2024, including a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types; (ii) CX-2051 (EpCAM): Continued Phase 1 dose escalation in solid tumors, primarily CRC; Initial Phase 1a data expected in the first half of 2025; (iii) CX-801 (IFNα2b): Continued Phase 1 dose escalation progress in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Initial Phase 1a data expected in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - P1/1b | N=100 | NCT05387265 | Sponsor: CytomX Therapeutics | "As of the April 16, 2024 data cutoff, CX-904 demonstrated a favorable safety profile including no observed cases of CRS of any grade in step-dosing cohorts and only Grade 1 CRS observed in patients treated at the highest non-step dose....Eight patients had measurable tumor reduction, including 2 of 6 (33%) efficacy-evaluable pancreatic cancer patients with confirmed partial responses per RECIST 1.1....CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose. The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024."

P1 data • Pancreatic Cancer

CytomX Therapeutics to Report First Quarter 2024 Results and Provide an Initial CX-904 Phase 1a Clinical Data Update on May 8, 2024 (GlobeNewswire) - "CytomX Therapeutics...announced that it will report first quarter 2024 results and provide an initial CX-904 Phase 1a dose escalation update on Wednesday, May 8, 2024, after the close of U.S. markets."

P1 data • Solid Tumor

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CX-904 (EGFRxCD3): Continued enrollment into Phase 1a dose escalation with initial data expected in the second half of 2024. These data are expected to inform a potential 2024 decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types."

P1 data • Trial status • Oncology • Solid Tumor

CytomX Therapeutics Outlines 2024 Company Priorities and Milestones (GlobeNewswire) - "CX-904 (EGFRxCD3): Continued enrollment into Phase 1a dose escalation. Phase 1a initial dose escalation data are expected in the second half of 2024. These data are expected to inform a potential decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types in 2024."

P1 data • Trial status • Oncology • Solid Tumor

CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CX-904, T-cell-engaging bispecific (TCB) targeted to EGFRxCD3, Phase 1 dose escalation data anticipated in the first half of 2024...Backfilling of certain dose escalation cohorts is being initiated during Q4 2023. Initial Phase 1a data for CX-904 is anticipated in the first half of 2024. A decision to initiate Phase 1b expansion cohorts in certain EGFR positive tumor types is anticipated in 2024....The IND for CX-2051 is expected to be filed by the end of 2023. CX-2051 Phase 1 dose escalation in solid tumors is anticipated in 2024, with metastatic colorectal cancer as a priority indication."

IND • New P1 trial • P1 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CytomX Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CX-904 is partnered with Amgen in a global co-development alliance and is being evaluated by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The primary goal of the ongoing initial dose escalation portion of the study is to assess safety and reach dose levels and exposures by the end of 2023 that support enrollment into backfill cohorts in select EGFR positive tumors. Initial Phase 1 dose escalation data for CX-904 is anticipated in the first half of 2024. Also, a decision to initiate expansion cohorts is anticipated in 2024, which will support future selection of the recommended Phase 2 dose."

P1 data • Trial status • Oncology • Solid Tumor

CytomX Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Continued progress in Phase 1 dose escalation for CX-904, T-cell-engaging bispecific (TCB) targeted to EGFRxCD3:...The primary goal of dose escalation is to assess safety and reach dose levels and exposures by the end of 2023 at which enrollment into backfill cohorts in certain EGFR positive tumors can begin. In 2024, a key milestone will be the selection of the recommended Phase 2 dose and decision to potentially initiate expansion cohorts."

Trial status • Oncology • Solid Tumor

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities (GlobeNewswire) - "2023 KEY MILESTONES AND OUTLOOK - CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study; File 2 New INDs: CX-801 (IFNa2b) and CX-2051 (EpCAM) projected in 2H 2023."

IND • Trial status • Oncology • Solid Tumor

CytomX Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2022/2023: (i) Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022; (ii) Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the fourth quarter of 2022; (iii) Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904."

Enrollment status • P2 data • Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

CytomX Therapeutics Announces First Patient Dosed with CX-904 in Phase 1 Study in Patients with Advanced Solid Tumors (GlobeNewswire) - "CytomX Therapeutics...announced that the first patient has been dosed in a Phase 1 dose-escalation study of CX-904 (NCT05387265). CX-904 is a conditionally activated T-cell-engaging bispecific (TCB) designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment."

Trial status • Oncology • Solid Tumor

A Trial to Find Safe and Active Doses for an Investigational Drug, CX-904, for Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: CytomX Therapeutics

New P1 trial • Oncology • Solid Tumor

CytomX Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2022: Continue enrolling patients with TNBC in Arms B and C in the Phase 2 study of praluzatamab ravtansine and report initial data from Arms A and B in the second half of 2022; Continue advancing the expansion phase of the Phase 2 study of CX-2029 in collaboration with our partner AbbVie and provide a data update in the second half of 2022; Advance the Phase 1 study of CX-904 in solid tumors."

Enrollment status • P2 data • Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

CytomX Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results, and Provides Business Update (GlobeNewswire) - "Priorities for 2022: (i) Initiate a Phase 1 study of CX-904 in advanced solid tumors in the first half of 2022; (ii) Continue patient enrollment in the expansion phase of the Phase 2 study of CX-2029 and provide additional data updates in the second half of 2022; (iii) Report initial data from Arms A and B in the Phase 2 study of praluzatamab ravtansine in patients with breast cancer in the second half of 2022."

Enrollment status • New P1 trial • P2 data • Breast Cancer • Oncology • Solid Tumor

CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-904 for the Treatment of Advanced Solid Tumors (GlobeNewswire) - "CytomX Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for CX-904, an EGFRxCD3 T-cell-engaging bispecific antibody being co-developed by CytomX and Amgen."

IND • Oncology • Solid Tumor

CytomX Therapeutics Announces Second Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "CytomX submitted a pre-investigational new drug application (IND) meeting request to the U.S. Food and Drug Administration (FDA) for CX-904 in collaboration with Amgen and expects a written response from the FDA in the third quarter of 2021. CytomX will continue to discuss the program with Amgen and is working toward the filing of an IND in late 2021."

IND • Oncology

CytomX Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (CytomX Press Release) - "Anticipated Events: Report initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021. Report initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021. Submit IND applications for CX-2043 and CX-904 in late 2021. Virtual analyst and investor briefing with Key Opinion Leaders in April 2021 to discuss our Probody technology platform with focus on praluzatamab ravtansine and CX-2029."

Clinical • IND • P2 data • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor