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A Single-Arm, Open-Label Phase Ia/Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)

1 juin 2026 mis à jour par: Foresight Therapeutics (Hefei) Co., Ltd.

This is a Phase Ia/Ib clinical study of FS-207, an investigational oral tablet, in patients with advanced solid tumors that are microsatellite instability-high, also called MSI-H. MSI-H tumors have specific changes in DNA repair pathways and may depend on the WRN protein to survive. FS-207 is designed to inhibit WRN.

The main purpose of this study is to evaluate the safety and tolerability of FS-207 and to understand how the drug moves through the body. The study will also look for early signs of anti-tumor activity.

This study has two parts. In the first part, called dose escalation, small groups of patients will receive increasing dose levels of FS-207 to help identify a safe and appropriate dose for further study. In the second part, called dose expansion, additional patients with selected MSI-H advanced solid tumors will receive FS-207 at dose level(s) chosen based on the earlier safety and clinical data.

Participants will take FS-207 orally once daily. Study doctors will monitor participants closely through physical examinations, blood and urine tests, electrocardiograms, heart function tests, imaging scans, and blood samples for pharmacokinetic testing. Tumor assessments will be performed regularly to evaluate whether the cancer has responded to treatment, remained stable, or progressed.

This is an open-label study, which means that both the participants and study doctors will know that FS-207 is being given. There is no placebo group in this study.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

156

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Beijing, Chine, 100730
        • Peking Union Medical College Hospital
      • Beijing, Chine, 100142
        • Peking University Cancer Hospital
        • Contact:
      • Shanghai, Chine, 200072
        • Shanghai Tenth People's Hospital
    • Anhui
      • Hefei, Anhui, Chine
        • The First Affiliated Hospital of Anhui Medical University
    • Fujian
      • Fuzhou, Fujian, Chine, 350014
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510080
        • Guangdong Provincial People's Hospital
    • Henan
      • Zhengzhou, Henan, Chine, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, Chine, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Hunan
      • Changsha, Hunan, Chine, 410013
        • Hunan Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Chine, 330029
        • Jiangxi Cancer Hospital
    • Jilin
      • Changchun, Jilin, Chine, 130012
        • Jilin cancer hospital
    • Liaoning
      • Shenyang, Liaoning, Chine, 110001
        • The First Affiliated Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, Chine, 750004
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, Chine, 250117
        • Cancer Hospital of Shandong First Medical School
      • Qingdao, Shandong, Chine, 266000
        • The Affiliated Hospital of Qingdao University
    • Sichuan
      • Chengdu, Sichuan, Chine, 610041
        • West China Hospital,Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 1) Male or female patients aged ≥18 years at the time of signing the Informed Consent Form; 2) Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors, whose disease has progressed or who have experienced intolerable toxicity following prior standard therapy. Additionally, participants must meet the following criterion: they have previously received treatment with at least one immune checkpoint inhibitor (ICI), and this treatment was deemed a failure due to disease progression or was discontinued due to intolerable toxicity; 3) Participants must provide a test report confirming a positive MSI-H/dMMR status in their tumor tissue; 4) Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0-1; 5) Anticipated life expectancy of ≥3 months; 6) Presence of at least one measurable lesion (according to RECIST v1.1 criteria, a measurable lesion is defined as a non-lymph node lesion with a longest diameter of ≥10 mm, or a lymph node lesion with a short axis of ≥15 mm, as measured by CT or MRI); 7) Female or male participants of childbearing potential must agree not to conceive, donate ova, or donate sperm from the date of signing the Informed Consent Form until 3 months after the last treatment administered in the study; furthermore, during this period, they must agree to utilize effective contraception (including one or more non-pharmacological contraceptive methods) or safety measures; 9) Agrees to comply with all requirements and procedures of the clinical trial and voluntarily signs the Informed Consent Form.

Exclusion Criteria:

  • 1) Known diagnosis of Werner syndrome; 2) Prior treatment with any medication targeting Werner syndrome helicase (WRN); 3) Receipt of any anti-tumor therapy within 3 weeks or 5 half-lives (whichever is longer) prior to the first dose; 4) Patients with adverse events related to prior anti-tumor therapy that have not resolved to Grade ≤1 (according to NCI CTCAE v6.0), excluding toxicities deemed by the investigator to pose no safety risk-such as alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement therapy, mild rash, hyperpigmentation, etc.-with specific cases subject to the investigator's judgment; 5) Undergone, or scheduled to undergo during the study period, major surgery (excluding procedures for vascular access placement, or biopsies performed via laparoscopy, mediastinoscopy, or thoracoscopy) within 4 weeks prior to the first dose; or undergone radical radiotherapy (palliative radiotherapy within 2 weeks prior to the first dose); 6) Leptomeningeal metastases; central nervous system (CNS) metastases with clinical symptoms; or other evidence indicating that CNS metastases are not adequately controlled, as determined by the investigator to render the participant unsuitable for enrollment. 7) Patients with symptomatic and unstable pleural effusion, ascites, or pericardial effusion, as determined by the investigator (patients whose clinical symptoms stabilize following therapeutic drainage of pleural fluid, ascites, or pericardial fluid may be enrolled); 8) Patients with other severe or uncontrolled systemic diseases, as determined by the investigator, including but not limited to interstitial lung disease, non-infectious pneumonitis; uncontrolled diabetes, renal disease requiring dialysis, severe hepatic disease (Child-Pugh Class B or C), acute pancreatitis, etc.; 9) Patients with cardiovascular diseases of significant clinical relevance;

    10) Patients with dysphagia, or gastrointestinal dysfunction or disease that could significantly affect the absorption of FS-207 tablets (e.g., severe ulcerative disease, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, etc.); 11) Patients with active autoimmune disease requiring systemic treatment, or a history of autoimmune disease with a potential for recurrence; 12) Patients with active Hepatitis B; active Hepatitis C; or Human Immunodeficiency Virus (HIV) infection; 13) Patients who have received a live vaccine or attenuated live vaccine within 4 weeks prior to the first dose of study medication; administration of inactivated vaccines is permitted; 14) Patients who have received treatment with other investigational drugs not yet approved for marketing, or who have participated in clinical trials involving interventional medical devices, within 4 weeks prior to the first dose of study medication; 15) Patients with active pulmonary tuberculosis (TB) (patients suspected of having active TB must undergo further evaluation by an infectious disease specialist to establish a definitive diagnosis) or a history of active TB; 16) Patients with any active infection requiring systemic treatment occurring within 2 weeks prior to the first dose of study medication; 17) Participants with a known or suspected history of severe allergic reactions to any component of the investigational drug, or a history of uncontrolled allergic asthma; 18) Patients who have previously undergone organ transplantation or allogeneic hematopoietic stem cell transplantation; 19) History of substance abuse, or known medical, psychological, or social conditions-such as a history of alcoholism or drug abuse; 20) Women who are pregnant or breastfeeding, or women of childbearing potential who have a positive pregnancy test result during the screening period; 21) Any other conditions that the investigator deems render the participant unsuitable for participation in this trial.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part 1A
FS-207 monotherapy dose escalation
Médicament: FS-207
FS-207 will be administered orally
Expérimental: Part 1B
FS-207 monotherapy Dose expansion and optimization
Médicament: FS-207
FS-207 will be administered orally

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Nombre de participants présentant une toxicité limitant la dose (TLD)
Délai: Jusqu'à 21 jours
Jusqu'à 21 jours
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Délai: Up to 3 years
Up to 3 years

Mesures de résultats secondaires

Mesure des résultats
Délai
Durée de réponse (DOR) selon RECIST v1.1
Délai: Jusqu'à 5 ans
Jusqu'à 5 ans
Taux de contrôle de la maladie (TCD) selon RECIST v1.1
Délai: Jusqu'à 5 ans
Jusqu'à 5 ans
Survie sans progression (PFS) selon RECIST v1.1
Délai: Jusqu'à 5 ans
Jusqu'à 5 ans
Survie globale (SG) selon RECIST v1.1
Délai: Jusqu'à 5 ans
Jusqu'à 5 ans
Maximum Serum Concentration (Cmax) of FS-207
Délai: up to 60 days
up to 60 days
Minimum Serum Concentration (Cmin) of FS-207
Délai: Up to 60 days
Up to 60 days
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of FS-207
Délai: Up to 60 days
Up to 60 days
Time to Achieve Cmax (Tmax) of FS-207
Délai: Up to 60 days
Up to 60 days
Confirmed Objective Response Rate(ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Délai: Up to 5 years
Up to 5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Foresight Therapeutics (Hefei) Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 mai 2026

Achèvement primaire (Estimé)

15 janvier 2029

Achèvement de l'étude (Estimé)

15 mai 2029

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

18 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • ForesightTx

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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