This is a first-in-human study (Phase I) conducted to find out how a new investigational drug works in a small number of participants with cancer. This helps researchers understand what happens with the investigational drug in the body and whether side effects (unwanted medical problems) occur.
Zusammenfassung der Studie
Furthermore, in the second part of the study, only participants with an amplification (too many copies) of a gene called «CCNE1» or those with high concentrations of a protein called Cyclin-E1 («overexpression»), a protein that arises from the CCNE1 gene in some gynecological, gastrointestinal, and breast cancers, will be included. Patients with other types of cancer with an amplification of the gene called «CCNE1» may also be included in the study. Patients with HR-positive/HER2-negative breast cancer may be included in the study without such characterization.
(BASEC)
Untersuchte Intervention
Study treatment:
The study is divided into 2 parts:
‐ In the first part, participants will receive the investigational drug INCB123667 at an initial dose defined in the study protocol. If this dose is well tolerated, additional participant groups will receive a higher dose of the investigational drug. The dose that participants receive depends on when the participant is enrolled in the study, as well as on the side effects that were also observed in previously enrolled participants. The goal of this first part is to determine which dose/doses of the investigational drug participants can take with the least possible side effects. Therefore, different doses of INCB123667 will be studied in successive patient groups during this first part of the study.
‐ In the second part of the study, participants will receive a dose of the investigational drug that has been established in Part 1 of the study and deemed safe and effective. In this part of the study, multiple dosing regimens or treatment plans may be studied.
Participants in this second part of the study will have selected cancers (see above). The goals of this second part of the study are to obtain more information about the safety, efficacy, and the "behavior" of the investigational drug when administered to participants with selected cancers.
The investigational drug is taken daily in tablet form (orally administered), until one of the following events occurs:
the participant's condition worsens
the participant requires a new cancer treatment
the participant can no longer tolerate the treatment
death
if the participant no longer wishes to participate in the study
if a serious event requires discontinuation of the investigational drug.
(BASEC)
Untersuchte Krankheit(en)
In Part 1 of the study, participants suffering from cancer, a disease in which abnormal cells divide uncontrollably and can spread to other parts of the body, will be included. Participants in this study meet the following criteria: • Have a cancer that has worsened during or after receiving a prior standard treatment • Have not tolerated or been able to receive the standard treatment(s) • Are patients for whom no treatment is available that could improve their condition.
(BASEC)
Inclusion criteria: In Part 1 of the study, participants suffering from cancer, a disease in which abnormal cells divide uncontrollably and can spread to other parts of the body, will be included. Participants in this study meet the following criteria: • Have a cancer that has worsened during or after receiving a prior standard treatment • Have not tolerated or been able to receive the standard treatment(s) • Are patients for whom no treatment is available that could improve their condition Furthermore, in the second part of the study, only patients with amplification (too many copies) of a gene called «CCNE1» or with high concentration of a protein called Cyclin-E1 («overexpression»), a protein that arises from the CCNE1 gene in some gynecological, gastrointestinal, and breast cancers, will be included in the study. Patients with other types of cancer with an amplification of the gene called «CCNE1» may also be included in the study. Patients with HR-positive/HER2-negative breast cancer may be included in the study without such characterization. Participants are adult patients. Participants agree, as necessary, to take all reasonable measures to avoid pregnancy or conceive a child during their participation in the study. Participants agree to undergo a biopsy/sample of their tumor prior to treatment if no archived tissue sample taken within 2 years prior to the first dose of the investigational drug is available. Participants should have adequate bone marrow, liver, and kidney function. (BASEC)
Ausschlusskriterien
Main exclusion criteria: Participants have a history of severe or uncontrolled heart disease. Participants have an active infection requiring drug treatment when starting the study. Participants have undergone major surgery or radiation therapy within 28 days prior to starting treatment with the investigational drug. Participants have previously been treated with a CDK2 inhibitor. (BASEC)
Studienstandort
Bellinzona, Bern, Lausanne
(BASEC)
Sponsor
Incyte Biosciences Sàrl Rue Docteur-Yersin 10 1110 Morges, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr.med.Simon Häfliger
+41 (0) 31 632 41 14
simon.haefliger@clutterinsel.chUniversitätsklinik für Medizinische Onkologie, Inselspital Bern, Freiburgstrasse 41, 3010 Bern
(BASEC)
Wissenschaftliche Auskünfte
Incyte Corporation,
1.855.463.3463
simon.haefliger@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
31.10.2022
(BASEC)
ICTRP Studien-ID
NCT05238922 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
INCB 123667-101 A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors (BASEC)
Wissenschaftlicher Titel
A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors (ICTRP)
Öffentlicher Titel
Study of INCB123667 in Subjects With Advanced Solid Tumors (ICTRP)
Untersuchte Krankheit(en)
Solid Tumors (ICTRP)
Untersuchte Intervention
Drug: INCB0123667Drug: PalbociclibDrug: BevacizumabDrug: OlaparibDrug: PaclitaxelDrug: RibociclibDrug: Fulvestrant (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Adults aged 18 years or older at the time of the signing of the ICF.
- Life expectancy greater than 12 weeks.
- ECOG performance status score of 0 or 1.
- Disease progression on prior standard treatment, intolerance to or ineligibility for
standard treatment, or no available treatment to improve the disease outcome.
- Availability of a baseline archival tumor specimen or willingness to undergo a
pretreatment and an on-treatment tumor biopsy.
For Part 1:
Participants in Part 1A (dose escalation): Histologically or cytologically confirmed
advanced or metastatic solid tumors.
Participants in Part 1B (dose expansion):
- Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
- Disease Group 2: Endometrial/Uterine Cancer
- Disease Group 3: Gastric, GEJ, and esophageal carcinomas
- Disease Group 4: TNBC
- Disease Group 5: HR+/HER2- breast cancer
- Disease Group 6: Other tumor indications excluding bone cancers
For Part 2:
Participants in Part 2A (dose escalation): Histologically or cytologically confirmed
advanced or metastatic solid tumors.
- TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer or
participants with a different tumor.
- TGB and TGD: Participants with HR+/HER2- breast cancer.
Participants in Part 2b (dose expansion):
- TGH and TGJ:
- Participants with HR+/HER2- breast cancer.
- Participants with any other advanced or metastatic solid tumor.
- TGI and TGK:
Participants with HR+/HER2- breast cancer.
- TGL, TGM and TGN:
Participants with advanced or metastatic epithelial ovarian/fallopian/primary
peritoneal carcinoma.
- Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
Exclusion Criteria:
- History of clinically significant or uncontrolled cardiac disease.
- History or presence of an ECG abnormality that, in the investigator's opinion, is
clinically meaningful.
- Presence of chronic or current active infectious disease requiring systemic
antibiotic, antifungal, or antiviral treatment.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS
metastases that have progressed.
- Known additional malignancy that is progressing or requires active treatment, or
history of other malignancy within 2 years of the first dose of study drug.
- Specific laboratory values.
- Significant concurrent, uncontrolled medical conditions, including but not limited
to Hepatic and Gastrointestinal.
- Has not recovered to = Grade 1 from toxic effects of prior therapy and/or
complications from prior surgical intervention before starting study drug.
- Prior treatment with any CDK2 inhibitor.
- Any change in endocrine therapy within 5 half-lives or 28 days (whichever is
shorter) before the first dose of study drug or any administration of targeted
therapy, antibody, or hypomethylating agent to treat the participant's disease
within 5 half-lives or 28 days (whichever is shorter) before the first dose of study
drug.
- Any major surgery within 28 days before the first dose of study drug.
- Any prior radiation therapy within 28 days before the first dose of study drug.
- Undergoing treatment with another investigational medication or having been treated
with an investigational medication within 5 half-lives or 28 days (whichever is
shorter) before the first dose of study drug.
- Active HBV or HCV infection that requires treatment.
- Known history of HIV.
- Known hypersensitivity or severe reaction to any component of study treatment or
formulation components.
Other protocol-defined Inclusion/Exclusion Criteria may apply. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Part 1A : Occurrence of Dose Limiting Toxicities (DLTs);Number of Participants With Treatment Emergent Adverse Events (TEAEs);Number of Participants with Dose Interruptions due to TEAE;Number of Participants who Undergo Dose Reductions due to TEAE;Number of Participants Discontinue study due to TEAE (ICTRP)
PK parameters: Cmax;PK parameters: tmax;PK parameters: Ctau;PK Parameters: AUC;PK Parameters: CL/F;PK Parameters: Vz/F;PK Parameters: t1/2;Objective Response Rate (ORR);Disease Control;Duration of Response (DOR) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Liz Croft, MD;Incyte Corporation Call Center (US), medinfo@incyte.com, 1.855.463.3463, Incyte Corporation, (ICTRP)
Sekundäre IDs
2021-005357-91, INCB 123667-101 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05238922 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar