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A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF CYC140, AN ORAL PLK1 INHIBITOR, IN SUBJECTS WITH ADVANCED SOLID TUMORS AND LYMPHOMA
EU CTIS ID: 2024-516290-67-00
What this study is testing
Phase 1: dose escalation To determine the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CYC140 when administered orally once daily (QD) in 28-day cycles in adult subjects with advanced solid tumors and lymphoma Phase 2: proof of concept To evaluate the preliminary efficacy of CYC140 as measured by overall response rate (ORR) in subjects with locally advanced, recurrent or metastatic, histologically confirmed advanced solid tumors or lymphoma who have failed all standard therapies or for whom standard therapy does not exist
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or females aged # 18 years or per local regulatory guidance
- Subjects with histological or cytologically-confirmed advanced cancer who have progressed on (or have not been able to tolerate) standard therapy or for whom no standard anticancer therapy is available a. For phase 1, all tumor types may be enrolled b. For phase 2, subjects will be enrolled as mentioned in the ‘study design’ section c. For phase 2, subjects should also meet the following criteria: i. Radiological progression as per RECIST (Lugano criteria for lymphoma, modified severity-weighted assessment tool [mSWAT] for CTCL) criteria on the last line of therapy before entering the trial must be documented ii. At least one measurable lesion as defined by the RECIST criteria (version 1.1) for solid tumors iii. For subjects with lymphoma based on Lugano Criteria (Cheson et al. 2014) and CTCL subjects based on mSWAT (Olsen)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease.
- WOCBP must have a negative pregnancy test (urine/serum) within 7 days prior initiating the study drug. Both males and females must agree to use effective birth control during the study (prior receiving first dose and for 6 months after the last dose) if conception is possible during this interval. Female subjects are considered to not be of childbearing potential if they have a history of hysterectomy or are postmenopausal (no menses for 12 months without an alternative medical cause). For both males and females, see Section 5.5 for the definitions of contraceptive methods considered effective for this protocol
- Subjects must be able to swallow and retain orally administered medication, and not have any clinically significant GI abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
You likely can't join if
- Subjects with a history of brain metastases or with signs/symptoms attributable to brain metastases and those who have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible
- Subjects who have not received vaccines for SARS-COV-2 and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19 Exclusions owing to medical conditions
- Subjects with a history of another primary malignancy other than: a. In situ carcinomas (e.g., breast, cervix and prostate) b. Locally excised non-melanoma skin cancer c. No evidence of the disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer
- Presence of an active infection requiring IV antibiotics
- Presence of a known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that might interfere with metabolism
- Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). In subjects with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, HBV DNA testing will be performed and if positive, the subject will be excluded. For subjects with HCV Ab positive, HCV viral load must be below the limit of quantification
See the full eligibility criteria
Who can join
- Male or females aged # 18 years or per local regulatory guidance
- Subjects with histological or cytologically-confirmed advanced cancer who have progressed on (or have not been able to tolerate) standard therapy or for whom no standard anticancer therapy is available a. For phase 1, all tumor types may be enrolled b. For phase 2, subjects will be enrolled as mentioned in the ‘study design’ section c. For phase 2, subjects should also meet the following criteria: i. Radiological progression as per RECIST (Lugano criteria for lymphoma, modified severity-weighted assessment tool [mSWAT] for CTCL) criteria on the last line of therapy before entering the trial must be documented ii. At least one measurable lesion as defined by the RECIST criteria (version 1.1) for solid tumors iii. For subjects with lymphoma based on Lugano Criteria (Cheson et al. 2014) and CTCL subjects based on mSWAT (Olsen)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Subjects who relapsed post-autologous or post-allogeneic transplant are eligible. Post-transplant subjects must be without active fungal disease or significant acute graft-versus-host disease.
- WOCBP must have a negative pregnancy test (urine/serum) within 7 days prior initiating the study drug. Both males and females must agree to use effective birth control during the study (prior receiving first dose and for 6 months after the last dose) if conception is possible during this interval. Female subjects are considered to not be of childbearing potential if they have a history of hysterectomy or are postmenopausal (no menses for 12 months without an alternative medical cause). For both males and females, see Section 5.5 for the definitions of contraceptive methods considered effective for this protocol
- Subjects must be able to swallow and retain orally administered medication, and not have any clinically significant GI abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
- Ability to agree to and sign the informed consent form, and comply with the protocol
What rules you out
- Subjects with a history of brain metastases or with signs/symptoms attributable to brain metastases and those who have not been assessed with radiologic imaging to rule out the presence of brain metastases. Subjects with treated brain metastases that are asymptomatic and have been clinically stable for at least 4 weeks will be eligible
- Subjects who have not received vaccines for SARS-COV-2 and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19 Exclusions owing to medical conditions
- Subjects with a history of another primary malignancy other than: a. In situ carcinomas (e.g., breast, cervix and prostate) b. Locally excised non-melanoma skin cancer c. No evidence of the disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer
- Presence of an active infection requiring IV antibiotics
- Presence of a known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that might interfere with metabolism
- Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV). In subjects with a history of HBV, hepatitis B core antibody (HBcAb) testing is required and if positive, HBV DNA testing will be performed and if positive, the subject will be excluded. For subjects with HCV Ab positive, HCV viral load must be below the limit of quantification
- Chemotherapy, biological therapy, targeted therapy, immunotherapy, extended-field radiotherapy or investigational agents within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1 or in those who have not recovered from the side-effects of such therapy
- Major surgery/surgical therapy for any cause within 4 weeks of the first dose
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.