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Study of ACR-2316 in Specific Advanced Solid Tumors

20 septembre 2026 mis à jour par: Acrivon Therapeutics

ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors

This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • Phase 2
  • 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

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85016
        • Recrutement
        • HonorHealth Research Institute
        • Chercheur principal:
          • Lyndsay Willmott, MD
        • Contact:
          • Amy Petersburg
    • California
      • Beverly Hills, California, États-Unis, 90212
        • Recrutement
        • Precision NextGen Oncology & Research Center
        • Contact:
          • Francisco Capilla
        • Chercheur principal:
          • Kamlesh K Sankhala, MD
      • Newport Beach, California, États-Unis, 92663
        • Recrutement
        • Hoag Memorial Hospital Presbyterian
        • Chercheur principal:
          • Monica Mita, MD
        • Contact:
          • Ariel Klingfus
    • Colorado
      • Denver, Colorado, États-Unis, 80218
        • Recrutement
        • Denver Health One
        • Chercheur principal:
          • Gerald Falchook, MD
        • Contact:
          • Rachel Morgan
    • Florida
      • Sarasota, Florida, États-Unis, 34232
        • Recrutement
        • Florida Cancer Specialist
        • Chercheur principal:
          • Judy S Wang, MD
        • Contact:
          • Mallory Hawkins
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Beth Israel Deaconess Medical Center
        • Chercheur principal:
          • Gerburg Wulf, MD
        • Contact:
          • Victoria Weden
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • Recrutement
        • University of Michigan
        • Contact:
          • Fatima Darwiche
        • Chercheur principal:
          • Zhen Ni Zhou, MD
    • New York
      • Buffalo, New York, États-Unis, 14203
        • Recrutement
        • Roswell Park Comprehensive Cancer Center
        • Chercheur principal:
          • Anuradha Krishnamurthy, MD
        • Contact:
          • Paige Wierzbicki
      • The Bronx, New York, États-Unis, 10461
        • Recrutement
        • Montefiore Medical Centre
        • Chercheur principal:
          • Nicole Nevadunsky, MD
        • Contact:
          • Sene Martin
    • North Carolina
      • Huntersville, North Carolina, États-Unis, 28078
        • Recrutement
        • Carolina BioOncology Institute
        • Chercheur principal:
          • Neel Gandhi, MD
        • Contact:
          • Hannah Wall
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Recrutement
        • Rhode Island Hospital
        • Chercheur principal:
          • Benedito Carneiro, MD
        • Contact:
          • Megan Faria
    • Tennessee
      • Franklin, Tennessee, États-Unis, 37067
        • Recrutement
        • Tennessee Oncology
        • Chercheur principal:
          • Jeff Russell, MD
        • Contact:
          • Catt Pecknold
    • Texas
      • Houston, Texas, États-Unis, 77054
        • Recrutement
        • The University of Texas MD Anderson Cancer Center
        • Chercheur principal:
          • Timothy A Yap, MD,PhD
        • Contact:
          • CR Registration Team Office of Clinical Research
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • NEXT Oncology
        • Chercheur principal:
          • David Sommerhalder, MD
        • Contact:
          • Jordan Georg
    • Virginia
      • Fairfax, Virginia, États-Unis, 22031
        • Recrutement
        • Next Virginia
        • Chercheur principal:
          • Mohamad Salkeni, MD
        • Contact:
          • Blake Patterson

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Signed written informed consent.
  2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
  3. Must be willing to provide redacted pathology report and next-generation sequencing (NGS) reports.
  4. Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
  6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
  7. Adequate organ functions.
  8. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

  1. Participants with known symptomatic brain metastases.
  2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
  3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
  4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
  5. Women who are pregnant or lactating.

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: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Dose escalation

ACR-2316 will be administered using a 3-week or a 4-week schedule.
Médicament: ACR-2316

ACR-2316 is an experimental drug
Expérimental: Dose expansion

ACR-2316 will be administered using a 3-week schedule.
Médicament: ACR-2316

ACR-2316 is an experimental drug

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dose Escalation
Délai: Number of DLT events during the DLT observation period (up to 28 days)

To determine the MTD of ACR-2316.
Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
Délai: RP2D supported by safety, PK and PD data through study completion

To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
RP2D supported by safety, PK and PD data through study completion
Dose Expansion
Délai: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.

To assess the safety and tolerability of ACR-2316
Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.
Dose Expansion
Délai: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.

To determine preliminary anti-tumor activity of ACR-2316.
Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Dose Escalation
Délai: This will be evaluated through study completion

To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
This will be evaluated through study completion
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: terminal elimination half-life (t½).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: apparent oral clearance (CL/F).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: terminal elimination half-life (t½).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Délai: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

To assess Pharmacokinetics: apparent oral clearance (CL/F).
Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is 21 days). Predose and multiple time points after dose up to Cycle 3.

Collaborateurs et enquêteurs

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

Parrainer

Acrivon Therapeutics

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 (Réel)

8 octobre 2024

Achèvement primaire (Estimé)

12 août 2027

Achèvement de l'étude (Estimé)

12 décembre 2027

Dates d'inscription aux études

Première soumission

23 octobre 2024

Première soumission répondant aux critères de contrôle qualité

29 octobre 2024

Première publication (Réel)

31 octobre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ACR-2316-101

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

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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