Solid Tumor, AdultPhase 1/2NCT04983810
A Study to Investigate Fadraciclib (CYC065), in Subjects With Advanced Solid Tumors and Lymphoma
A Phase 1/2 study testing Fadraciclib in people with Solid Tumor, Adult and Lymphoma, run by Cyclacel Pharmaceuticals, Inc. at 4 sites in 3 countries.
Trial summary
This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. 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?
- Fadraciclib
- 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
- 4 sitesin 3 countries
- Study dates
- 12 Jul 2021to 30 Jun 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
- Age ≥ 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 or 1
- 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 t he 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 SARS-COV-2 within last 3 months and have suspected signs and symptoms of COVID-19 or a recent history (within 14 days) of contact with any COVID-19 positive subject/isolation/quarantine or subjects with confirmed COVID-19.
- Subjects with a history of another primary malignancy, other than:
- Carcinomas in situ, 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 fadraciclib.
- 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
4 sites in 3 countries.
Julius Huang, PhD contact
4 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Aruna Parikh, arparikh@coh.org
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Meng Gao, mgao@mdanderson.org
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 Fadraciclib (CYC065), an Oral CDK 2/9 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, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. 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: Endometrial or Ovarian cancer
Group 2: Biliary tract cancer
Group 3: HCC
Group 4: Breast cancer, meeting any of the following criteria:
- HER-2 refractory MBC
- HR positive, HER-2 negative, MBC post-CDK4/6 inhibitor
- Triple-negative breast cancer (TNBC)
Group 5: B-cell lymphoma
Group 6: T-cell lymphoma (CTCL and PTCL)
Group 7: mCRC, including KRAS mutated mCRC
Group 8: Basket cohort: Tumor types suspected to have a related mechanism of action such as MCL1, MYC or CCNE amplification/overexpression not included in previous groups.
- Conditions
- Solid Tumor, Adult, Lymphoma
- Being tested
- Fadraciclib
- Keywords
- Solid tumor, lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FadraciclibDrug
Also called CYC065
Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose escalation | Experimental | Phase I = Fadraciclib administered orally in escalating doses starting at 50mg bid MWF 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 = Recommended Fadraciclib phase 2 dose and schedule administered orally in 28 day cycles. Receives: Drug: Fadraciclib |
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 (5)
Adverse events
Type, frequency, and severity of adverse drug reactions
Measured: 24 months
AUC
Fadraciclib plasma concentrations
Measured: 6 months
Cmax
Fadraciclib plasma concentrations
Measured: 6 months
Tmax
Fadraciclib plasma concentrations
Measured: 6 months
T1/2
Fadraciclib plasma concentrations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start12 Jul 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 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, AdultStudies 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
- Not applicable
- 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
- Investigators
- Mark H Kirschbaum, MD, Study chair, Cyclacel Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983810
- Sponsor's protocol ID
- CYC065-101
- Status last verified
- Jan 2024
- First submitted
- 12 Jul 2021
- Last updated
- 25 Jan 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 25 Jan 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 Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma
- ClinicalTrials.gov ID
- NCT04983810
- Acronym / sponsor ID
- CYC065-101
- Conditions
- Solid Tumor, Adult, Lymphoma
- Keywords
- Solid tumor, 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
- 12 Jul 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Jul 2021 (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, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. 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: Endometrial or Ovarian cancer
Group 2: Biliary tract cancer
Group 3: HCC
Group 4: Breast cancer, meeting any of the following criteria:
- HER-2 refractory MBC
- HR positive, HER-2 negative, MBC post-CDK4/6 inhibitor
- Triple-negative breast cancer (TNBC)
Group 5: B-cell lymphoma
Group 6: T-cell lymphoma (CTCL and PTCL)
Group 7: mCRC, including KRAS mutated mCRC
Group 8: Basket cohort: Tumor types suspected to have a related mechanism of action such as MCL1, MYC or CCNE amplification/overexpression not included in previous groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation in Phase 1 part.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose escalation | Experimental | Drug: FadraciclibPhase I = Fadraciclib administered orally in escalating doses starting at 50mg bid MWF 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 = Recommended Fadraciclib 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 (8 listed)
- Age ≥ 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 or 1
- 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.
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 SARS-COV-2 within last 3 months and have suspected signs and symptoms of COVID-19 or a recent history (within 14 days) of contact with any COVID-19 positive subject/isolation/quarantine or subjects with 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 fadraciclib.
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 |
|---|---|---|
| FadraciclibAlso: CYC065Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9. | Drug | Phase I Dose escalation |
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
5 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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
Mark H Kirschbaum, MD study chair
Cyclacel Pharmaceuticals, Inc.
4 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 Fadraciclib in people with Solid Tumor, Adult and Lymphoma, run by Cyclacel Pharmaceuticals, Inc. at 4 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 8 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 25 Jan 2024.