CytomX Therapeutics Provides Update on CX-2051 Phase 1 Study
CytomX Therapeutics (NASDAQ:CTMX) provided an update on its Phase 1 study of CX-2051 for colorectal cancer treatment. The CTMX-2051-101 study has successfully enrolled 73 patients across three dose expansion cohorts (7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W), with approximately 20 patients per dose level.
The company reported a single Grade 5 treatment-related adverse event involving acute kidney injury in a patient with a complex medical history. Following this event, reported to the FDA on July 18, 2025, the Safety Review Committee supported continued study execution. CytomX remains on track to provide a Phase 1 data update in Q1 2026.
CytomX Therapeutics (NASDAQ:CTMX) ha fornito un aggiornamento sullo studio di Fase 1 di CX-2051 per il trattamento del cancro colorettale. Lo studio CTMX-2051-101 ha arruolato con successo 73 pazienti in tre coorti di espansione di dose (7,2 mg/kg, 8,6 mg/kg e 10 mg/kg somministrati ogni 3 settimane), con circa 20 pazienti per livello di dose.
L'azienda ha segnalato un unico evento avverso di grado 5 correlato al trattamento, consistente in un'insufficienza renale acuta in un paziente con una storia medica complessa. Questo evento, notificato alla FDA il 18 luglio 2025, 猫 stato valutato dal Safety Review Committee che ha supportato la prosecuzione dello studio. CytomX conferma di essere in linea per fornire un aggiornamento sui dati di Fase 1 nel primo trimestre 2026.
CytomX Therapeutics (NASDAQ:CTMX) ofreci贸 una actualizaci贸n sobre su estudio de Fase 1 de CX-2051 para el tratamiento del c谩ncer colorrectal. El estudio CTMX-2051-101 ha inscrito con 茅xito a 73 pacientes en tres cohortes de expansi贸n de dosis (7,2 mg/kg, 8,6 mg/kg y 10 mg/kg cada 3 semanas), con aproximadamente 20 pacientes por nivel de dosis.
La compa帽铆a inform贸 un 煤nico evento adverso relacionado con el tratamiento de grado 5, consistente en una lesi贸n renal aguda en un paciente con antecedentes m茅dicos complejos. Tras este suceso, notificado a la FDA el 18 de julio de 2025, el Comit茅 de Revisi贸n de Seguridad respald贸 la continuaci贸n del estudio. CytomX mantiene su previsi贸n de ofrecer una actualizaci贸n de datos de Fase 1 en el primer trimestre de 2026.
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CytomX Therapeutics (NASDAQ:CTMX) a fourni une mise 脿 jour sur son essai de phase 1 de CX鈥�2051 pour le traitement du cancer colorectal. L'茅tude CTMX鈥�2051鈥�101 a enr么l茅 avec succ猫s 73 patients r茅partis dans trois cohortes d'extension de dose (7,2 mg/kg, 8,6 mg/kg et 10 mg/kg toutes les 3 semaines), avec environ 20 patients par niveau de dose.
La soci茅t茅 a signal茅 un unique 茅v茅nement ind茅sirable li茅 au traitement de grade 5 : une insuffisance r茅nale aigu毛 chez un patient pr茅sentant des ant茅c茅dents m茅dicaux complexes. Cet 茅v茅nement, d茅clar茅 脿 la FDA le 18 juillet 2025, a 茅t茅 examin茅 par le comit茅 de revue de s茅curit茅 qui a appuy茅 la poursuite de l'茅tude. CytomX reste en bonne voie pour fournir une mise 脿 jour des donn茅es de phase 1 au 1er trimestre 2026.
CytomX Therapeutics (NASDAQ:CTMX) gab ein Update zu seiner Phase鈥�1鈥慡tudie mit CX鈥�2051 zur Behandlung von Darmkrebs bekannt. Die Studie CTMX鈥�2051鈥�101 hat erfolgreich 73 Patienten in drei Dosis鈥慐xpansionskohorten (7,2 mg/kg, 8,6 mg/kg und 10 mg/kg alle drei Wochen) rekrutiert, mit jeweils etwa 20 Patienten pro Dosisstufe.
Das Unternehmen berichtete von einem einzelnen grad鈥�5 behandlungsbedingten unerw眉nschten Ereignis 鈥� akutes Nierenversagen bei einem Patienten mit komplexer Krankengeschichte. Dieser Vorfall wurde am 18. Juli 2025 der FDA gemeldet, und das Safety Review Committee bef眉rwortete die Fortf眉hrung der Studie. CytomX bleibt im Zeitplan, ein Phase鈥�1鈥慏atenupdate im 1. Quartal 2026 zu liefern.
- Rapid Phase 1 enrollment with 73 patients recruited to date
- Study continues with support from Safety Review Committee despite adverse event
- On track for planned data update in Q1 2026
- Grade 5 (fatal) treatment-related adverse event reported in one patient
- Safety concerns emerged with acute kidney injury in treated patient
- The CTMX-2051-101 study has enrolled 73 colorectal cancer patients to-date, aligned with the Company鈥檚 goal of providing a Phase 1 data update in Q1 2026 -
- The CTMX-2051-101 study remains active and patients continue to be dosed with CX-2051 across all expansion doses -
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today provided an update on the CX-2051 Phase 1 study to address certain recent social media posts.聽聽
鈥淪ince our initial data disclosure in May 2025, Phase 1 enrollment has been rapid and is substantially complete. We are on track to provide a data update in the first quarter of 2026. Patient safety remains our top priority as we continue to advance CX-2051 for the treatment of CRC,鈥� said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.
CX-2051 Program Status:
- CX-2051 dose expansions at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) have each enrolled approximately 20 patients as planned.
- A single Grade 5 treatment-related acute kidney injury occured in a patient with a complex medical history including having a solitary kidney. The Grade 5 event was believed to be secondary to nausea, vomiting and diarrhea. The Company was made aware of the event on July 11, 2025 and promptly reported the event to the FDA on July 18, 2025 in accordance with regulatory requirements.
- The CTMX-2051-101 Safety Review Committee convened on July 14, 2025 and supported continued study execution and enrollment. 聽聽
- The CTMX-2051-101 study is ongoing. A Phase 1 data update is expected by Q1 2026.
About聽CytomX Therapeutics
CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY庐 therapeutic platform, CytomX鈥檚 vision is to create safer, more effective therapies for the treatment of cancer. CytomX鈥檚 multi-modality technology platform has produced therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (ADCs), T-cell engagers, and immune modulators such as cytokines. CytomX鈥檚 current clinical-stage pipeline includes CX-2051 and CX-801. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM), armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen. CX-801 is a masked interferon alpha-2b PROBODY庐 cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit聽聽and follow us on聽听补苍诲听 (formerly Twitter).
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to CX-2051. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX鈥檚 or any of its collaborative partners鈥� product candidates, including CX-2051 and CX-801, the potential benefits or applications of CytomX鈥檚 PROBODY庐 therapeutic platform, CytomX鈥檚 or its collaborative partners鈥� ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2051 and CX-801 and the timing of initial and ongoing data availability for our clinical trials, including CX-2051 and CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX鈥檚 novel PROBODY庐 therapeutic technology; uncertainties around the Company鈥檚 ability to raise sufficient funds to carry out its planned research and development; CytomX鈥檚 clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-2051 results, may not be predictive of future results; the possibility that CytomX鈥檚 clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX鈥檚 dependence on the success of CX-2051 and CX-801; CytomX鈥檚 reliance on third parties for the manufacture of the Company鈥檚 product candidates; possible regulatory developments in the United States and foreign countries, including China and the European Union; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX鈥檚 Quarterly Report on Form 10-Q filed with the SEC on August 7, 2025. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. All other trademarks are the properties of their respective owners.
Company Contact:
Chris Ogden
SVP, Chief Financial Officer
Investor Contact:
Precision AQ (formerly Stern Investor Relations)
Stephanie Ascher
Media Contact:
Redhouse Communications
Teri Dahlman
FAQ
What is the current status of CytomX's CX-2051 Phase 1 trial for colorectal cancer?
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