Context Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of CTIM-76
Context Therapeutics (CNTX) has initiated its Phase 1 clinical trial for CTIM-76, a Claudin 6 x CD3 T cell engaging bispecific antibody, with the first patient now dosed. The trial focuses on patients with CLDN6-positive gynecologic and testicular cancers.
The open-label study will evaluate safety and efficacy in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer. The trial aims to assess safety, tolerability, pharmacokinetics, and anti-tumor activity through metrics including overall response rate, duration of response, and disease control rate. Expected to enroll up to 70 patients, the company anticipates sharing initial data in the first half of 2026.
Context Therapeutics (CNTX) ha avviato il suo studio clinico di Fase 1 per CTIM-76, un anticorpo bispecifico che coinvolge le cellule T Claudin 6 x CD3, con il primo paziente già trattato. Lo studio si concentra su pazienti affetti da cancro ginecologico e testicolare positivo per CLDN6.
Lo studio open-label valuterà la sicurezza e l'efficacia in soggetti con cancro ovarico, endometriale e testicolare avanzato o metastatico positivo per CLDN6. L'obiettivo della sperimentazione è valutare la sicurezza, la tollerabilità, la farmacocinetica e l'attività anti-tumorale attraverso metriche comprese la percentuale di risposta complessiva, la durata della risposta e il tasso di controllo della malattia. È previsto il reclutamento di fino a 70 pazienti, e l'azienda prevede di condividere i dati iniziali nella prima metà del 2026.
Context Therapeutics (CNTX) ha iniciado su ensayo clínico de Fase 1 para CTIM-76, un anticuerpo bispecífico que activa las células T Claudin 6 x CD3, con el primer paciente ya tratado. El ensayo se centra en pacientes con cánceres ginecológicos y testiculares positivos para CLDN6.
El estudio abierto evaluará la seguridad y la eficacia en sujetos con cáncer de ovario, endometrial y testicular avanzado o metastático positivo para CLDN6. El objetivo del ensayo es evaluar la seguridad, la tolerabilidad, la farmacocinética y la actividad antitumoral mediante métricas que incluyen la tasa de respuesta global, la duración de la respuesta y la tasa de control de la enfermedad. Se espera reclutar hasta 70 pacientes, y la empresa anticipa compartir datos iniciales en la primera mitad de 2026.
컨텍스트 테라퓨틱스 (CNTX)가 CTIM-76에 대한 1상 임상 시험을 시작했으며, 이는 Claudin 6 x CD3 T 세포 참여 이중 특이성 항체로, 첫 번째 환자가 이미 투여되었습니다. 이 시험은 CLDN6 양성 부인과 및 고환 암 환자에 초점을 맞추고 있습니다.
이 공개 연구는 CLDN6 양성 진행성 또는 전이성 난소, 자궁 내막 및 고환 암 환자의 안전성과 효능을 평가합니다. 이 시험은 전반적인 반응률, 반응 지속 시간 및 질병 조절률을 포함한 지표를 통해 안전성, 내약성, 약동학 및 항종양 활성을 평가하는 것을 목표로 합니다. 최대 70명의 환자를 모집할 예정이며, 회사는 2026년 상반기에 초기 데이터를 공유할 것으로 예상하고 있습니다.
Context Therapeutics (CNTX) a lancé son essai clinique de Phase 1 pour CTIM-76, un anticorps bispécifique engageant les cellules T Claudin 6 x CD3, avec le premier patient déjà traité. L'essai se concentre sur les patients atteints de cancers gynécologiques et testiculaires positifs pour CLDN6.
L'étude en ouvert évaluera la sécurité et l'efficacité chez des sujets atteints d'un cancer de l'ovaire, de l'endomètre ou testiculaire avancé ou métastatique positif pour CLDN6. L'objectif de l'essai est d'évaluer la sécurité, la tolérabilité, la pharmacocinétique et l'activité anti-tumorale à travers des métriques comme le taux de réponse global, la durée de la réponse et le taux de contrôle de la maladie. Il est prévu de recruter jusqu'à 70 patients, et la société prévoit de partager des données initiales dans la première moitié de 2026.
Context Therapeutics (CNTX) hat seine Phase-1-Studie für CTIM-76 eingeleitet, einen bispezifischen Antikörper, der T-Zellen mit Claudin 6 x CD3 verbindet, und der erste Patient wurde bereits behandelt. Die Studie konzentriert sich auf Patienten mit CLDN6-positiven gynäkologischen und Hodenkrebs.
Die offene Studie wird Sicherheit und Wirksamkeit bei Probanden mit fortgeschrittenem oder metastasierendem Eierstock-, Gebärmutter- und Hodenkrebs, die CLDN6-positiv sind, bewerten. Ziel der Studie ist es, Sicherheit, Verträglichkeit, Pharmakokinetik und antitumorale Aktivität durch Kennzahlen zu bewerten, zu denen auch die Gesamtansprechrate, die Dauer des Ansprechens und die Krankheitskontrollrate gehören. Es wird erwartet, bis zu 70 Patienten zu rekrutieren, und das Unternehmen plant, in der ersten Hälfte des Jahres 2026 erste Daten zu teilen.
- Successful initiation of Phase 1 clinical trial with first patient dosed
- Trial design includes both dose escalation and expansion phases
- Clear timeline provided for initial data release in H1 2026
- Extended timeline for initial data (approximately 18 months)
- patient enrollment size (70 patients)
Insights
The initiation of Phase 1 clinical trials for CTIM-76 represents a important development in Context Therapeutics' pipeline. The trial design targeting CLDN6-positive gynecologic and testicular cancers with a 70-patient enrollment target is strategically sound. The dual focus on dose escalation and expansion will provide comprehensive safety and efficacy data, while the inclusion of multiple cancer types enhances the potential market opportunity.
The anticipated data readout in H1 2026 suggests a well-paced trial timeline. The study's endpoints encompassing safety, tolerability, pharmacokinetics and anti-tumor activity metrics are comprehensive and align with industry standards for early-phase oncology trials. The bispecific antibody approach targeting CLDN6 x CD3 is particularly noteworthy as it leverages cutting-edge T cell engagement technology, which has shown promise in other oncology applications.
CTIM-76's development targets a significant unmet need in CLDN6-positive cancers. The bispecific antibody's mechanism of action, engaging T cells to target CLDN6-expressing tumor cells, represents a sophisticated approach in immuno-oncology. Recent SITC presentation data supporting the first-in-human dose selection indicates robust preclinical validation.
For investors, this milestone reduces development risk and validates the company's platform. The focus on gynecologic and testicular cancers is strategic, as these indications often have treatment options in advanced stages. The potential market opportunity is substantial, though competition from other emerging immunotherapies should be monitored. Think of CTIM-76 as a precision-guided missile system, where T cells are the missiles and CLDN6 is the target's unique signature.
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers
Trial marks key milestone in driving pipeline progress
PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating CTIM-76, a Claudin 6 (“CLDN6”) x CD3 T cell engaging bispecific antibody. The Phase 1 dose escalation and expansion trial is enrolling patients with CLDN6-positive gynecologic and testicular cancers. The Company anticipates sharing initial data for the CTIM-76 Phase 1 trial in the first half of 2026.
“Dosing of the first patient in the CTIM-76 Phase 1 trial represents a key advancement of our clinical pipeline,” said Martin Lehr, CEO of Context. “We recently presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), supporting the selection of this first-in-human dose and highlighting the potential of CTIM-76 to treat CLDN6-positive cancers.”
“We look forward to advancing CTIM-76 toward target dose levels in 2025," commented Claudio Dansky Ullmann, M.D., Chief Medical Officer of Context.
The Phase 1 clinical trial is an open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancer. 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 study is expected to enroll up to 70 patients.
About CTIM-76
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy.
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 (CLDN6) x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. 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 have initial data in the first half of 2026 for CTIM-76, (ii) our expectation to advance CTIM-76 toward target dose levels in 2025, (iii) our expectation to enroll up to 70 patients in our Phase 1 clinical trial evaluating CTIM-76, (iv) the potential benefits, characteristics, safety and side effect profile of our product candidates, (v) the likelihood data will support future development of our product candidates, and (vi) 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
Context Therapeutics
IR@contexttherapeutics.com
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