A Study of DCC-3116 in Combination with Cancer Therapies in Participants with Advanced Cancer (Module B)
Résumé de l'étude
DCC-3116 is an investigational drug designed to slow down or stop a key process that helps cancer cells survive. Researchers are conducting this study to find out if adding DCC-3116 to another cancer treatment called Ripretinib can help improve outcomes for people with GIST. Ripretinib is used to treat advanced GIST. Participants take both medications orally (by mouth).
(BASEC)
Intervention étudiée
This study consists of two parts. Only the second part of this study (Part 2) is being conducted in Switzerland. In Part 1 of the study, participants received various doses of DCC-3116 in combination with Ripretinib to determine the dose or doses with manageable side effects to be used in Part 2 of the study. The investigator and study staff will monitor the health status and safety of participants throughout the study. In Part 2 of this study, the main goal is to learn more about the effect and safety of one or more specific doses of DCC-3116 in combination with Ripretinib. • The primary objective is to measure how much the participants' tumor shrinks or disappears by a certain percentage. • A secondary objective is to learn more about the cancer-fighting effect of one or more doses of DCC-3116 in combination with Ripretinib by measuring when and how long the cancer-fighting effect lasts, what percentage of participants' tumors have shrunk, disappeared, or remained stable, and how long participants survive after starting treatment and before cancer worsens. • Additional secondary objectives include learning more about the safety of one or more doses of DCC-3116 in combination with Ripretinib, how well the combination is tolerated by participants, and what happens in the body after administering the combination (how the drug is absorbed, distributed, metabolized, and then excreted as waste).
(BASEC)
Maladie en cours d'investigation
A solid tumor is any type of cancer where an abnormal mass of tissue has formed in the body. Advanced or metastatic tumors are those that have spread from their original site to other parts of the body. This clinical study focuses on individuals with an advanced or metastatic type of cancer that starts in the digestive system and is referred to as gastrointestinal stromal tumor (GIST), and who have a documented gene mutation. Genes instruct the cells in your body on what to do. In cancer, the genes are altered, so these instructions are no longer correct.
(BASEC)
Eligible participants are individuals who are at least 18 years old and have advanced GIST with a documented gene mutation. Participants must have previously been treated with another cancer medication (specifically Imatinib for Part 2). However, their cancer must be advanced or they must have experienced intolerable side effects. Additionally, participants must have tumors that have tested positive for certain genetic mutations that play a role in the development of advanced GIST. (BASEC)
Critères d'exclusion
Participation is not possible if the person has previously been treated with DCC-3116 or Ripretinib. Furthermore, individuals who have certain conditions or are taking specific medications that make participation unsafe or could prevent them from completing the study procedures are also not allowed to participate. (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Deciphera Pharmaceuticals, LLC IQVIA AG, Branch Basel
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Attila Kollar
+41 316324195
attila.kollar@clutterinsel.chInselspital - Universitaetsspital Bern Universitaetsklinik für Medizinische Onkologie Freiburgstrasse 4 3010, Bern
(BASEC)
Informations générales
Deciphera Pharmaceuticals, LLC
888-724-3274
Clinicaltrials@deciphera.com(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
11.09.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT05957367 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies. (BASEC)
Titre académique
A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies (ICTRP)
Titre public
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies (ICTRP)
Maladie en cours d'investigation
GIST (ICTRP)
Intervention étudiée
Drug: InlexisertibDrug: Ripretinib (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Male or female =18 years of age
- Module A: Part 1 and Part 2:
Module A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no
participants enrolled.
- Module B: Only for Part 1 (Safety/Dose-finding):
- Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived
growth factor receptor alpha (PDGFRA) mutation
- Must have progressed on at least one approved systemic regimen given in the
locally advanced or metastatic setting or have documented intolerance to it
- Must not have received prior ripretinib treatment
- Module B: Only for Part 2 (Expansion)
- Pathologically confirmed GIST with documented mutation in KIT exon 11
- Must have progressed on imatinib given in the locally advanced or metastatic
setting or have been intolerant to imatinib and may not have received
additional systemic therapy for GIST
- Must have at least 1 measurable lesion according to Modified Response Evaluation
Criteria in Solid Tumors (mRECIST)
- Must have a life expectancy of more than 3 months and an ECOG performance status of
0-1
- Adequate organ function and bone marrow reserve based on laboratory assessments
performed at Screening
- Must provide a fresh tumor biopsy, if able
Exclusion Criteria:
- Must not have received the following within the specified time periods prior to the
first dose of study drug:
1. Medications, including anticancer therapies, that are known strong or moderate
inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain
herbal medications (eg, St. John's wort): 14 days or 5the half-life of the
medication (whichever is longer)
2. Other anticancer therapies and any investigational therapies with a known
safety and PK profile: 14 days or 5the half-life of the medication (whichever
is shorter)
3. Investigational therapies with unknown safety and PK profile: 28 days. If there
is enough data on the investigational therapy to assess the risk for drug-drug
interactions and late toxicities of prior therapy as low, the Sponsor's Medical
Monitor may approve a shorter washout of 14 days
4. Grapefruit or grapefruit juice: 14 days
- Have not recovered from all clinically relevant toxicities from prior therapy
- New York Heart Association Class III or IV heart disease, active ischemia, or any
other uncontrolled cardiac condition, clinically significant cardiac arrhythmia
requiring therapy, uncontrolled hypertension, congestive heart failure, or
myocardial infarction within 6 months prior to the first dose of study drug
- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal
disease
- Malabsorption syndrome
- Radiation for indications other than bone disease must have been completed 4 weeks
prior to first dose of study drug, unless it consisted of limited field palliative
radiation, including whole brain radiation, which must have been completed at least
2 weeks prior to first dose of study drug
- Major surgery within 4 weeks of the first dose of study drug
- Active HIV, Hepatitis B or Hepatitis C infection (ICTRP)
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Critères d'évaluation principaux et secondaires
Incidence of Adverse Events (Escalation Phase);Recommended Phase 2 Doses (RP2D) (Escalation Phase);Objective response rate (ORR) (Expansion Phase) (ICTRP)
Duration of response (DoR);Disease Control Rate (DCR);Time to response;Progression-free survival (PFS);Overall Survival (OS);Maximum observed concentration (Cmax);Time to maximum observed concentration (Tmax);Minimum observed concentration (Cmin);Area under the concentration-time curve (AUC) (ICTRP)
Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
Clinical TeamClinical Team, Clinicaltrials@deciphera.com, 888-724-3274, Deciphera Pharmaceuticals, LLC (ICTRP)
ID secondaires
2024-516476-15-00, DCC-3116-01-002 (ICTRP)
Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05957367 (ICTRP)
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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