Compass Therapeutics Announces First Patient Dosed in an Investigator Sponsored Trial of Tovecimig in the First-Line Setting for Patients with Biliary Tract Cancer
Compass Therapeutics (CMPX) has initiated dosing in a new Investigator Sponsored Trial (IST) evaluating tovecimig as a first-line treatment for biliary tract cancer (BTC). The trial, conducted at MD Anderson Cancer Center, will study tovecimig in combination with gemcitabine, cisplatin, and durvalumab in approximately 50 patients with unresectable or metastatic BTC.
The study includes a safety run-in phase with 12 patients, followed by an expansion phase with 38 additional patients. Primary objectives include assessing 6-month progression-free survival, safety, and determining maximum tolerated dose. The company recently announced that tovecimig met its primary endpoint in their ongoing Phase 2/3 second-line BTC study, with secondary endpoint results expected in Q4 2025.
Compass Therapeutics (CMPX) ha iniziato la somministrazione in un nuovo studio sponsorizzato da un ricercatore (IST) che valuta tovecimig come trattamento di prima linea per il tumore delle vie biliari (BTC). Lo studio, condotto presso il MD Anderson Cancer Center, analizzerà tovecimig in combinazione con gemcitabina, cisplatino e durvalumab in circa 50 pazienti con BTC non resecabile o metastatico.
Lo studio prevede una fase iniziale di sicurezza con 12 pazienti, seguita da una fase di espansione con ulteriori 38 pazienti. Gli obiettivi principali includono la valutazione della sopravvivenza libera da progressione a 6 mesi, la sicurezza e la determinazione della dose massima tollerata. L'azienda ha recentemente annunciato che tovecimig ha raggiunto l'endpoint primario nel loro studio di Fase 2/3 in corso per il BTC in seconda linea, con i risultati degli endpoint secondari attesi nel quarto trimestre 2025.
Compass Therapeutics (CMPX) ha iniciado la dosificación en un nuevo ensayo patrocinado por un investigador (IST) que evalúa tovecimig como tratamiento de primera línea para el cáncer de vías biliares (BTC). El ensayo, realizado en el MD Anderson Cancer Center, estudiará tovecimig en combinación con gemcitabina, cisplatino y durvalumab en aproximadamente 50 pacientes con BTC irresecable o metastásico.
El estudio incluye una fase inicial de seguridad con 12 pacientes, seguida de una fase de expansión con 38 pacientes adicionales. Los objetivos principales incluyen evaluar la supervivencia libre de progresión a 6 meses, la seguridad y determinar la dosis máxima tolerada. La compañía anunció recientemente que tovecimig cumplió su objetivo principal en su estudio en curso de Fase 2/3 para BTC en segunda línea, con resultados de objetivos secundarios esperados en el cuarto trimestre de 2025.
Compass Therapeutics (CMPX)가 담도암(BTC) 1차 치료제로서 토베시미그의 투여를 시작하는 새로운 연구자 후원 임상시험(IST)을 개시했습니다. 이 임상시험은 MD 앤더슨 암센터에서 진행되며, 절제가 불가능하거나 전이된 BTC 환자 약 50명을 대상으로 토베시미그를 젬시타빈, 시스플라틴, 듀발루맙과 병용하여 평가합니다.
연구는 12명의 환자를 대상으로 한 안전성 초기 투여 단계를 거친 후 38명의 환자를 추가로 포함하는 확장 단계로 진행됩니다. 주요 목표는 6개월 무진행 생존율 평가, 안전성 확인, 최대 허용 용량 결정입니다. 회사는 최근 진행 중인 2/3상 2차 BTC 연구에서 토베시미그가 1차 평가변수를 충족했으며, 2차 평가변수 결과는 2025년 4분기에 발표될 예정이라고 밝혔습니다.
Compass Therapeutics (CMPX) a commencé l'administration dans un nouvel essai sponsorisé par un investigateur (IST) évaluant tovecimig en tant que traitement de première intention du cancer des voies biliaires (BTC). L'essai, mené au MD Anderson Cancer Center, étudiera tovecimig en combinaison avec la gemcitabine, le cisplatine et le durvalumab chez environ 50 patients atteints de BTC non résécable ou métastatique.
L'étude comprend une phase initiale de sécurité avec 12 patients, suivie d'une phase d'expansion avec 38 patients supplémentaires. Les objectifs principaux incluent l'évaluation de la survie sans progression à 6 mois, la sécurité et la détermination de la dose maximale tolérée. La société a récemment annoncé que tovecimig avait atteint son critère d'évaluation principal dans leur étude de phase 2/3 en cours sur le BTC en deuxième ligne, avec des résultats des critères secondaires attendus au quatrième trimestre 2025.
Compass Therapeutics (CMPX) hat mit der Dosierung in einer neuen von Forschern initiierten Studie (IST) begonnen, die tovecimig als Erstlinientherapie für Gallengangskrebs (BTC) untersucht. Die Studie, die am MD Anderson Cancer Center durchgeführt wird, untersucht tovecimig in Kombination mit Gemcitabin, Cisplatin und Durvalumab bei etwa 50 Patienten mit nicht resektablem oder metastasiertem BTC.
Die Studie umfasst eine Sicherheits-Einführungsphase mit 12 Patienten, gefolgt von einer Erweiterungsphase mit weiteren 38 Patienten. Die Hauptziele sind die Bewertung des progressionsfreien Überlebens nach 6 Monaten, die Sicherheit und die Bestimmung der maximal verträglichen Dosis. Das Unternehmen gab kürzlich bekannt, dass tovecimig den primären Endpunkt in ihrer laufenden Phase-2/3-Studie für die Zweitlinientherapie von BTC erreicht hat, mit sekundären Endpunktergebnissen, die im vierten Quartal 2025 erwartet werden.
- Tovecimig met primary endpoint in Phase 2/3 second-line BTC study
- Expansion into first-line treatment setting broadens potential market opportunity
- Partnership with prestigious MD Anderson Cancer Center for clinical trial
- Results from secondary endpoints still pending
- Safety profile in combination therapy yet to be established
Insights
Compass's tovecimig advances to first-line biliary cancer testing following positive Phase 2/3 results, expanding potential therapeutic applications.
Compass Therapeutics has reached a significant clinical milestone with the first patient dosed in an Investigator Sponsored Trial (IST) evaluating tovecimig in first-line biliary tract cancer (BTC) treatment. This advancement is particularly noteworthy as it follows their recent announcement that tovecimig met the primary endpoint in their Phase 2/3 study in second-line BTC.
The scientific approach here merits attention - tovecimig is a DLL4 x VEGF-A bispecific antibody targeting two critical pathways involved in tumor angiogenesis. This dual-targeting mechanism offers potential advantages over single-pathway approaches in controlling tumor blood vessel formation.
This new MD Anderson-led trial combines tovecimig with the current standard first-line regimen (gemcitabine, cisplatin, and durvalumab) in approximately 50 patients with unresectable or metastatic BTC. The study's structure includes an appropriate safety run-in phase with 12 patients before expanding to include 38 additional participants.
From a clinical development perspective, progressing from second-line to first-line testing represents a natural evolution that could significantly expand tovecimig's therapeutic reach. BTC remains a challenging cancer with effective treatment options, making novel approaches critically important.
The study's comprehensive endpoints include 6-month progression-free survival, safety assessments, and determination of maximum tolerated dose, with secondary measures examining overall response rate, duration of response, progression-free survival, and overall survival. Additionally, secondary endpoint results from their Phase 2/3 study are expected in Q4 2025, which will provide further insights into tovecimig's efficacy profile.
BOSTON, April 21, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, announced the first patient has been dosed in an Investigator Sponsored Trial (IST) to evaluate tovecimig (CTX-009, a DLL4 x VEGF-A bispecific antibody) for the first time in the front-line setting for patients with biliary tract cancer (BTC). The IST is being conducted at The University of Texas MD Anderson Cancer Center.
“This first-line study of tovecimig in patients with BTC represents a significant step forward and we are deeply grateful to the dedicated team at MD Anderson for their leadership in conducting this trial,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “The IST complements our ongoing second-line Phase 2/3 study of tovecimig in patients with biliary tract cancer; importantly, we recently announced that tovecimig met the primary endpoint in our Phase 2/3 Study. We expect to report results of the secondary endpoints in the Phase 2/3 Study, including progression-free survival (PFS) and overall survival (OS), in the fourth quarter of this year.”
In the MD Anderson-led, open-label trial, tovecimig is being added to a standard first-line regimen of gemcitabine, cisplatin, and durvalumab in an estimated 50 patients with unresectable or metastatic BTC. The study will have a standard safety run-in phase in 12 patients followed by an expansion phase in which 38 additional patients will be treated. The primary objectives in the study are to assess 6-month progression-free survival, to assess the tolerability and safety of this combination, and to determine the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS). For more information on the IST: NCT06548412
About Tovecimig (CTX-009)
Tovecimig is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of tovecimig suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to tovecimig as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to approved anti-VEGF therapies. COMPANION-002, a Phase 2/3 trial of tovecimig plus paclitaxel versus paclitaxel monotherapy in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers (BTC) is ongoing (clinical trial information: NCT05506943).
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof, including the potential of tovecimig as a treatment option for patients with BTC. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.
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FAQ
What are the primary objectives of CMPX's new tovecimig first-line trial for biliary tract cancer?
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What is the combination therapy being tested in CMPX's first-line biliary tract cancer trial?
When will CMPX report secondary endpoint results for their Phase 2/3 tovecimig study?
