Context Therapeutics Doses First Patient in Phase 1 Clinical Trial of CT-95
Context Therapeutics (CNTX) has initiated dosing in the Phase 1 clinical trial of CT-95, a mesothelin x CD3 T cell engaging bispecific antibody. CT-95 targets mesothelin-expressing cancers, which are present in approximately 30% of all cancers. This marks Context's second active clinical trial in 2025, following the CTIM-76 trial launched earlier this year.
The Phase 1 trial (NCT06756035) is designed as an open-label, dose escalation and expansion study to evaluate CT-95's safety and efficacy in patients with mesothelin-expressing advanced solid tumors, including ovarian, pancreatic, lung, and mesothelioma cancers. The dose escalation portion is expected to enroll up to 30 patients, with initial data anticipated in mid-2026.
The study will assess safety, tolerability, pharmacokinetics, and anti-tumor activity metrics including overall response rate, duration of response, and disease control rate.
Context Therapeutics (CNTX) ha avviato la somministrazione nel trial clinico di Fase 1 di CT-95, un anticorpo bispecifico che coinvolge le cellule T x CD3 e che si lega al mesotelina. CT-95 mira ai tumori che esprimono mesotelina, presenti in circa il 30% di tutti i tumori. Questo segna il secondo trial clinico attivo di Context nel 2025, dopo il trial CTIM-76 lanciato all'inizio di quest'anno.
Il trial di Fase 1 (NCT06756035) è progettato come uno studio aperto, di escalation della dose e di espansione per valutare la sicurezza e l'efficacia di CT-95 in pazienti con tumori solidi avanzati che esprimono mesotelina, inclusi tumori ovarici, pancreatici, polmonari e mesotelioma. La parte di escalation della dose prevede l'arruolamento di fino a 30 pazienti, con dati iniziali previsti per metà del 2026.
Lo studio valuterà la sicurezza, la tollerabilità, la farmacocinetica e le metriche di attività anti-tumorale, inclusi il tasso di risposta globale, la durata della risposta e il tasso di controllo della malattia.
Context Therapeutics (CNTX) ha iniciado la dosificación en el ensayo clínico de Fase 1 de CT-95, un anticuerpo bispecífico que involucra células T x CD3. CT-95 se dirige a los cánceres que expresan mesotelina, que están presentes en aproximadamente el 30% de todos los cánceres. Esto marca el segundo ensayo clínico activo de Context en 2025, tras el ensayo CTIM-76 lanzado a principios de este año.
El ensayo de Fase 1 (NCT06756035) está diseñado como un estudio abierto, de escalación de dosis y expansión para evaluar la seguridad y eficacia de CT-95 en pacientes con tumores sólidos avanzados que expresan mesotelina, incluidos cánceres de ovario, páncreas, pulmón y mesotelioma. Se espera que la parte de escalación de dosis inscriba hasta 30 pacientes, con datos iniciales anticipados para mediados de 2026.
El estudio evaluará la seguridad, tolerabilidad, farmacocinética y métricas de actividad antitumoral, incluidos el tasa de respuesta global, la duración de la respuesta y la tasa de control de la enfermedad.
Context Therapeutics (CNTX)는 CT-95의 1상 임상 시험에서 투약을 시작했습니다. CT-95는 mesothelin x CD3 T 세포를 유도하는 이중 특이성 항체입니다. CT-95는 약 30%의 모든 암에서 발견되는 mesothelin을 발현하는 암을 목표로 합니다. 이는 2025년 Context의 두 번째 활성 임상 시험으로, 올해 초 시작된 CTIM-76 시험에 이어 진행됩니다.
1상 시험 (NCT06756035)은 mesothelin을 발현하는 고급 고형 종양, 즉 난소암, 췌장암, 폐암 및 중피종 암 환자에서 CT-95의 안전성과 효능을 평가하기 위한 공개 라벨, 용량 증량 및 확장 연구로 설계되었습니다. 용량 증량 부분은 최대 30명의 환자를 등록할 것으로 예상되며, 초기 데이터는 2026년 중반에 예상됩니다.
이 연구는 안전성, 내약성, 약물 동태학, 그리고 전체 반응률, 반응 지속 시간 및 질병 조절률을 포함한 항종양 활동 지표를 평가할 것입니다.
Context Therapeutics (CNTX) a lancé la dose dans l'essai clinique de Phase 1 de CT-95, un anticorps bispécifique engageant les cellules T x CD3. CT-95 cible les cancers exprimant la mésothelin, présents dans environ 30 % de tous les cancers. Cela marque le deuxième essai clinique actif de Context en 2025, après l'essai CTIM-76 lancé plus tôt cette année.
L'essai de Phase 1 (NCT06756035) est conçu comme une étude ouverte, d'escalade de dose et d'expansion pour évaluer la sécurité et l'efficacité de CT-95 chez des patients atteints de tumeurs solides avancées exprimant la mésothelin, y compris les cancers de l'ovaire, du pancréas, du poumon et le mésothéliome. La partie d'escalade de dose devrait recruter jusqu'à 30 patients, avec des données initiales attendues pour la mi-2026.
L'étude évaluera la sécurité, la tolérabilité, la pharmacocinétique et les indicateurs d'activité antitumorale, y compris le taux de réponse global, la durée de la réponse et le taux de contrôle de la maladie.
Context Therapeutics (CNTX) hat die Dosierung in der Phase-1-Studie von CT-95 begonnen, einem bispezifischen Antikörper, der mesothelin x CD3 T-Zellen aktiviert. CT-95 zielt auf mesothelin-exprimierende Krebserkrankungen ab, die in etwa 30 % aller Krebserkrankungen vorkommen. Dies markiert die zweite aktive klinische Studie von Context im Jahr 2025, nach der im Laufe dieses Jahres gestarteten CTIM-76-Studie.
Die Phase-1-Studie (NCT06756035) ist als offene, dosissteigernde und erweiternde Studie konzipiert, um die Sicherheit und Wirksamkeit von CT-95 bei Patienten mit fortgeschrittenen soliden Tumoren, die mesothelin exprimieren, einschließlich Eierstock-, Bauchspeicheldrüsen-, Lungen- und Mesotheliomkrebs, zu bewerten. Der Teil zur Dosissteigerung wird voraussichtlich bis zu 30 Patienten einschreiben, wobei erste Daten für Mitte 2026 erwartet werden.
Die Studie wird Sicherheit, Verträglichkeit, Pharmakokinetik sowie Anti-Tumor-Aktivitätsmetriken, einschließlich der Gesamtansprechrate, der Dauer des Ansprechens und der Krankheitskontrollrate, bewerten.
- Second T cell engaging bispecific antibody entering clinical trials in 2025
- Broad potential market with mesothelin expression in 30% of all cancers
- Pipeline expansion with two active clinical trials
- Initial data not available until mid-2026
- Early-stage Phase 1 trial with uncertain outcomes
- to 30 patients in dose escalation portion
Insights
Context Therapeutics' dosing of the first patient in its CT-95 Phase 1 trial represents standard pipeline advancement for the
CT-95 targets mesothelin (MSLN), a protein overexpressed in
From an investment perspective, this milestone reflects pipeline progression rather than a value-inflecting catalyst. The study design appears standard for early oncology development, enrolling up to 30 patients in dose escalation. However, with data not expected until mid-2026, investors face a significant wait for efficacy signals.
Context now shoulders the operational and financial responsibilities of running two parallel Phase 1 programs. While this diversifies clinical risk, it also accelerates cash burn - an important consideration for a small-cap biotech. The company's approach to T cell engagers puts them in a competitive landscape with many larger players, though targeting specific tumor antigens may provide differentiation if successful.
The advancement of CT-95 into clinical testing represents a mechanistically sound approach to targeting solid tumors. Mesothelin (MSLN) is an established cancer antigen with high expression in several aggressive malignancies with poor prognosis, including pancreatic cancer, mesothelioma, and certain ovarian cancers - all areas with significant unmet medical need.
The bispecific antibody design that redirects CD3+ T cells to MSLN-expressing cancer cells could potentially overcome the immunosuppressive tumor microenvironment that has efficacy of previous immunotherapy approaches in these cancers. However, the critical questions of manageable toxicity profile, optimal dosing, and preliminary efficacy signals remain unanswered until initial data emerges in 2026.
From a clinical perspective, Context's dual-track development strategy targeting both MSLN and Claudin 6 demonstrates a thoughtful approach to addressing different tumor types through precision T cell redirection. The dose escalation enrollment target of 30 patients is appropriate for safety assessment across multiple tumor types.
The key challenge for MSLN-targeting therapies historically has been achieving sufficient therapeutic window between tumor efficacy and on-target/off-tumor toxicity, particularly in pleural and peritoneal tissues where low-level MSLN expression occurs. The design of CT-95 will need to demonstrate advantages over previous MSLN-targeting approaches that have shown efficacy in the clinic.
CT-95 is a mesothelin x CD3 T cell engaging bispecific antibody
CT-95 is Context’s second T cell engaging bispecific antibody to enter the clinic in 2025
PHILADELPHIA, April 09, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95, a mesothelin (“MSLN”) x CD3 T cell engaging (“TCE”) bispecific antibody designed to target mesothelin-expressing cancers. The Company anticipates sharing initial data for the CT-95 Phase 1 trial in mid-2026.
This milestone marks Context’s second active clinical trial, following the dosing of the first patient in the CTIM-76 trial earlier this year. CTIM-76 is a Claudin 6 (“CLDN6”) x CD3 TCE bispecific antibody currently being evaluated in CLDN6-positive tumors, including ovarian, endometrial, and testicular cancers.
MSLN is a membrane protein overexpressed in an estimated
“Dosing of the first patient in our CT-95 Phase 1 clinical trial represents another step forward in our mission to develop next generation precision immunotherapies for solid tumors,” said Martin Lehr, CEO of Context. “With both CT-95 and CTIM-76 now dosed in initial patients, we are advancing our clinical pipeline and expanding our leadership in T cell engaging bispecific antibody therapies.”
The Phase 1 clinical trial of CT-95 (NCT06756035) is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CT-95 in subjects with MSLN-expressing advanced solid tumors, including ovarian, pancreatic, lung, and mesothelioma cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response, and disease control rate. The dose escalation portion of the study is expected to enroll up to 30 patients.
About CT-95
CT-95 is a MSLN x CD3 bispecific antibody that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN. MSLN is a membrane protein overexpressed in approximately
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.
Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) our expectation to share initial data in mid-2026 for CT-95, (ii) our expectation to enroll up to 30 patients in the dose escalation portion of the Phase 1 clinical trial evaluating CT-95, (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) the likelihood data will support future development, and (v) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
Investor Relations Contact:
Jennifer Minai-Azary
Chief Financial Officer
Context Therapeutics Inc.
IR@contexttherapeutics.com
FAQ
When will Context Therapeutics (CNTX) release initial data for the CT-95 Phase 1 trial?
How many patients will the CT-95 Phase 1 trial dose escalation study enroll?
What types of cancers does Context Therapeutics' CT-95 target?
What are the primary endpoints of CNTX's CT-95 Phase 1 clinical trial?
How prevalent is mesothelin expression in cancers that CT-95 targets?
