Solid Tumor, Adult LymphomaPhase 1/2NCT05358379
A Study to Investigate CYC140, in Subjects With Advanced Solid Tumors and Lymphoma
A Phase 1/2 study testing CYC140 in people with Solid Tumor, Adult Lymphoma, run by Cyclacel Pharmaceuticals, Inc. at 5 sites in 3 countries.
Trial summary
This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult Lymphoma
- What is being tested?
- CYC140
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 14 Apr 2022to Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 years.
- Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
- For Phase 1, all tumor types may be enrolled
- For Phase 2, subjects will be enrolled as per the study design section above
- 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
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- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
- Subjects must be able to swallow and retain orally administered medication and not have any clinically significant GI abnormalities that may alter the absorption, such as malabsorption syndrome or major resection of the stomach or bowels.
- Able to agree to and sign the informed consent and to comply with the protocol.
Who cannot join
- Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and 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 severe acute respiratory syndrome-corona virus-2 (SARS-COV-2) and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19.
- Subjects with a history of another primary malignancy, other than:
- In situ carcinomas, e.g., breast, cervix, and prostate
- Locally excised nonmelanoma skin cancer
- No evidence of disease from another primary cancer for 2 or more years and has not taken any anti-cancer treatment in 2 years.
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- Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results.
- Diseases that significantly affect GI absorption of CYC140.
- Subjects who have impaired cardiac function or clinically significant cardiac disease.
- Presence of active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
- Presence of an active infection requiring intravenous antibiotics
- Presence of known history of human immunodeficiency virus-1/2 with uncontrolled viral load and on medications that may interfere with metabolism
- Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 3 weeks (whichever is shorter) prior to administration of first dose of study drug on Day 1 or have not recovered from the side effects of such therapy.
- Major surgery/surgical therapy for any cause within 4 weeks of the first dose
Trial locations and contacts
5 sites in 3 countries.
Julius Huang, PhD contact
5 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Miguel Villalona-Calero, MD, mvillalona@coh.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Meng Gao, mgao@mdanderson.org
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Julie Urban, IDDCreferrals@upmc.edu
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Do-Youn Oh, Prof. MD, ohdoyoun@snu.ac.kr
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona
Elena Garralda Cabanas, MD, egarralda@vhio.net
About this study
Official title: 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
This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists.
Read the detailed description
Phase 1 part of the study will consist of a dose-escalation and a dose-finding component.
Phase 2 will enroll 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, into 8 groups:
Group 1: Bladder cancer
Group 2: Breast cancer: Triple-negative breast cancer (TNBC)
Group 3: Lung cancer (non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC])
Group 4: Hepatocellular carcinoma (HCC) and biliary tract cancer (BTC)
Group 5: Metastatic colorectal cancer (mCRC) including KRAS-mutated mCRC
Group 6: B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL)
Group 7: T-cell lymphoma (cutaneous T-cell lymphoma [CTCL] and peripheral T-cell lymphoma [PTCL])
Group 8: Basket cohort: tumor types that are suspected to have a related mechanism of action but are not included in previous groups including, esophageal, prostate, ovarian and pancreatic cancers
- Conditions
- Solid Tumor, Adult Lymphoma
- Being tested
- CYC140
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYC140Drug
CYC140 is a highly selective, orally- and intravenously- available, ATP-competitive inhibitor of PLK1.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved. Receives: Drug: CYC140 |
| Phase 2 | Experimental | Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles. Receives: Drug: CYC140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
Measured: 6 months
Overall Response Rate (ORR)
Assessment of response criteria according to RESIST, Lugano or mSWAT.
Measured: 18 months
Secondary outcomes (9)
Adverse events
Type, frequency, and severity of adverse drug reactions
Measured: 24 months
AUC
CYC140 plasma concentrations
Measured: 6 months
Cmax
CYC140 plasma concentrations
Measured: 6 months
Tmax
CYC140 plasma concentrations
Measured: 6 months
T1/2
CYC140 plasma concentrations
Measured: 6 months
Disease Control Rate
To evaluate the disease control rate (DCR) in subjects receiving CYC140.
Measured: 24 months
Duration of Response
To evaluate the duration of response (DOR) in subjects receiving CYC140.
Measured: 24 months
Progression-free Survival
To evaluate progression-free survival (PFS) in subjects receiving CYC140.
Measured: 24 months
Overall Survival
To evaluate overall survival (OS) in subjects receiving CYC140.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start14 Apr 2022
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Adult LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation in Phase 1 part
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358379
- Sponsor's protocol ID
- CYC140-101
- Status last verified
- Feb 2024
- First submitted
- 19 Apr 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05358379
- Acronym / sponsor ID
- CYC140-101
- Conditions
- Solid Tumor, Adult Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, pharmacogenomics, and efficacy of CYC140 administered orally daily. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists.
Detailed description
Phase 1 part of the study will consist of a dose-escalation and a dose-finding component.
Phase 2 will enroll 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, into 8 groups:
Group 1: Bladder cancer
Group 2: Breast cancer: Triple-negative breast cancer (TNBC)
Group 3: Lung cancer (non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC])
Group 4: Hepatocellular carcinoma (HCC) and biliary tract cancer (BTC)
Group 5: Metastatic colorectal cancer (mCRC) including KRAS-mutated mCRC
Group 6: B-cell lymphoma including diffuse large B-cell lymphoma (DLBCL)
Group 7: T-cell lymphoma (cutaneous T-cell lymphoma [CTCL] and peripheral T-cell lymphoma [PTCL])
Group 8: Basket cohort: tumor types that are suspected to have a related mechanism of action but are not included in previous groups including, esophageal, prostate, ovarian and pancreatic cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation in Phase 1 part
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: CYC140Phase 1 = CYC140 administered orally in escalating doses starting at 5mg QD M-F week 1 to 3 for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved. |
| Phase 2 | Experimental | Drug: CYC140Phase 2 = Recommended CYC140 phase 2 dose and schedule administered orally in 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females aged ≥ 18 years.
- Subjects with histological- or cytological-confirmed, advanced cancer who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists
- 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
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females must agree to use effective birth control during the study (prior to the first dose and for 6 months after the last dose) if conception is possible during this interval.
Key exclusion criteria (15 listed)
- Subjects with a history of brain metastases or who have signs/symptoms attributable to brain metastases and 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 severe acute respiratory syndrome-corona virus-2 (SARS-COV-2) and have suspected signs and symptoms of the novel coronavirus infection (COVID-19) or have confirmed COVID-19.
- Subjects with a history of another primary malignancy, other than:
- Any other clinically significant acute or chronic medical or psychiatric condition or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results.
- Diseases that significantly affect GI absorption of CYC140.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYC140CYC140 is a highly selective, orally- and intravenously- available, ATP-competitive inhibitor of PLK1. | Drug | Phase 1 Dose Escalation, Phase 2 |
Primary outcome
Maximum tolerated dose
Time frame: 6 months
The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
Overall Response Rate (ORR)
Time frame: 18 months
Assessment of response criteria according to RESIST, Lugano or mSWAT.
9 secondary outcomes
Adverse events
Time frame: 24 months
AUC
Time frame: 6 months
Cmax
Time frame: 6 months
Tmax
Time frame: 6 months
T1/2
Time frame: 6 months
Disease Control Rate
Time frame: 24 months
Duration of Response
Time frame: 24 months
Progression-free Survival
Time frame: 24 months
Overall Survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julius Huang, PhD contact
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYC140 in people with Solid Tumor, Adult Lymphoma, run by Cyclacel Pharmaceuticals, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, South Korea, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark H Kirschbaum, MD (626-316-3394, mkirschbaum@cyclacel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.