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Looking for participantsPhase1/Phase2

A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies

Sponsor: Carrick Therapeutics Limited

NCT ID: NCT06600789

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) (drug)
How long the study runs
Study runs about 31 months (dates as stated)
About the drug or intervention
CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) — drug: CT7439 capsules administered by mouth once a day as monotherapy with a single starting dose of 1mg in Cohort 1 on Cycle 0 Day 1, followed by a minimum 48 hours treatment -free period before continuous daily dosing in cycles of 28 days (Cycle1 onwards) until DLT or disease progression is observed.
Patient visit burden
Not specified by the sponsor

In plain English

This is an early-stage (phase 1/2) study testing a new drug called CT7439 in people with solid tumours (cancers that form lumps, rather than blood cancers). The study is run in parts called modules, and is paid for (sponsored) by Carrick Therapeutics Limited.

Who can take part

  • You have a confirmed diagnosis of a solid cancer that can be measured on scans using standard guidelines (RECIST version 1.1)
  • You are well enough to carry out daily activities with little or no help (a performance status score of 2 or less on the ECOG scale, with no worsening over the past 2 weeks)
  • You can take medicines by mouth and are willing to keep a daily record of taking the study drug
  • You are expected to live at least 3 more months, in the study doctor's opinion
  • You have given written informed consent and are willing and able to attend all study visits, tests and treatments, and to allow the study team access to your stored tumour samples, past scans and tumour marker results
  • Women must be past the menopause or unable to have children, or if able to have children, must use effective contraception during the study and for at least 33 days after the last dose of CT7439
  • Sexually active men must agree to use condoms with all partners and not donate sperm during the study and for at least 93 days after the last dose
  • For the extra part of the study called Module 1: your cancer is locally advanced or has spread, and there is no treatment that could cure it

Who may not be able to

  • You have had treatment with a drug that blocks CDK12/13 (the target of this new medicine) at any time before
  • You have had another cancer that was active or treated in the past 3 years (except pre-cancer of the cervix, called cervical intraepithelial neoplasia, and non-melanoma skin cancer)
  • You still have side effects from earlier treatment (grade 2 or worse on a standard scale), except hair loss
  • You have an autoimmune disease now or in the past
  • You have cancer that has spread to the brain or spinal cord, now or in the past
  • You have an infection needing antibiotic, antifungal or antiviral medicine within 14 days before the first dose
  • You have a severe or uncontrolled illness, including a mental health condition
  • You have HIV, unless you have been on HIV treatment for at least 4 weeks and have not had a serious infection in the past 12 months
  • You have active hepatitis B or hepatitis C, unless hepatitis B is controlled with antiviral medicine or the hepatitis C level is too low to measure
  • You are pregnant or breastfeeding
  • You had cancer treatment (chemotherapy or other cancer drugs) within 28 days before the first dose
  • You took steroid medicines within 14 days before the first dose
  • You took another experimental medicine within 28 days or 5 half-lives (whichever is longer) before the first dose
  • You took certain medicines, herbal supplements or foods that interfere with how the body handles CT7439 (affecting proteins called CYP3A4, CYP2D6, P-gp or BCRP) within 21 days before the first dose
  • Your liver, kidneys or bone marrow are not working well enough, or you had a blood transfusion within 14 days before the first dose
  • You have had severe drops in all blood cell counts for more than 4 weeks due to previous treatment rather than the cancer
  • You have a history of heart problems or heart disease that is clinically significant
  • You have had a live vaccine within 28 days before treatment starts

What taking part involves

  • • Taking CT7439 as an oral medicine (a tablet or capsule swallowed by mouth)
  • • Recording daily that you have taken the study drug

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
50
Started
2024-08-16
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for solid malignancies
  • • Phase1/Phase2 - 50 participants
  • • This modular, multi-part, multi-arm, Phase 1/2, FIH study allows the evaluation of the safety and tolerability of CT7439, dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid malignancies

Where?

  • • Manchester - Research site 05
  • • Oxford - Research site 04
  • • Sutton - Research site 06

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This modular, multi-part, multi-arm, Phase 1/2, FIH study allows the evaluation of the safety and tolerability of CT7439, dosed as a monotherapy and in combination with anticancer treatment in participants with solid malignancies.

More detail

This study will initially evaluate CT7439 as a monotherapy in participants with locally advanced or metastatic solid malignancies, i.e., Module 1, which includes dose escalation cohort (Part A). \- Part A of Module 1: a First-in Human dose escalation investigating the safety and tolerability of CT7439 to identify the minimum biologically active dose (MBAD) and either maximum tolerated dose (MTD) or maximum feasible dose (MFD) of CT7439 when dosed as monotherapy. SRC, consisting of study investigators and sponsor medical personnel, will be formed to monitor the safety, tolerability, PK, and PDc data during this part of the study. In Part A, cohorts (maximum 6) will be opened sequentially following review from the SRC who will make recommendations on CT7439 dosage selection for subsequent cohorts. Participants will continue to receive IMP until evidence of disease progression, unacceptable toxicities, the participant withdraws their informed consent or is withdrawn from the study, or completion of the primary study analysis. Further cohort(s) of specific participant sub-populations may be initiated in Module 1 following approval of a protocol amendment.

Solid Malignancies

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Histopathologically or cytologically confirmed diagnosis of malignant disease evaluable by (standard scan measurements)
  • ✓ECOG performance status of ≤ 2 with no deterioration over the previous 2 weeks.
  • ✓Ability to take oral medications and be willing to record daily adherence to the the study treatment.
  • ✓Estimated expected to live at least 3 $2, in the opinion of the investigator.

Who cannot take part

  • ✗Prior therapy with a specific CDK12/13 inhibitor, within any timeframe prior to the first dose of CT7439.
  • ✗Any unresolved toxicity (except alopecia) from prior therapy of ≥ 2 Common Terminology Criteria for Adverse Events...
  • ✗Active or documented history of autoimmune disease.
  • ✗Any current or prior central nervous system metastases
  • ✗Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first...
See the full criteria
Core Inclusion Criteria: * Histopathologically or cytologically confirmed diagnosis of malignant disease evaluable by RECIST v1.1 * Provision of signed written informed consent before any study-related activities, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures and willing to permit access to stored historical tumor tissue, prior tumor radiological assessments and tumor biomarker data. * ECOG performance status of ≤ 2 with no deterioration over the previous 2 weeks. * Ability to take oral medications and be willing to record daily adherence to the study drug. * Women either of non-childbearing potential, either confirmed to be post-menopausal or of childbearing potential willing to practice effective contraception for the duration of the study and for minimum 33 days after the last dose of CT7439. * Sexually active male patients must be willing to refrain from sperm donation from the time of signing informed consent and use condoms with all sexual partners for the duration of the study and for a minimum 93 days months after the last dose of CT7439. * Estimated life expectancy of at least 3 months, in the opinion of the investigator. Core Exclusion Criteria: * Prior therapy with a specific CDK12/13 inhibitor, within any timeframe prior to the first dose of CT7439. * Participants with any other malignancy that have been active or treated within the past 3 years prior to enrolment, with the exception of cervical intraepithelial neoplasia and non-melanoma skin cancer. * Any unresolved toxicity (except alopecia) from prior therapy of ≥ 2 Common Terminology Criteria for Adverse Events (CTCAE) Grade. * Active or documented history of autoimmune disease. * Any current or prior central nervous system metastases * Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of study drug. * Severe or uncontrolled medical condition or psychiatric condition. * Human immunodeficiency virus (HIV) infection, unless the study participant on anti-retroviral therapy for at least 4 weeks (28 days) and has not had an opportunistic infection within the past 12 months prior to enrolment. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, unless participant with HBV patient is on a suppressive antiviral therapy, or participant with HCV has a viral load below the limit of quantification (LoQ). * Participant is breastfeeding or pregnant. * Receipt of cytotoxic and/or non- cytotoxic treatment for the malignancy within 28 days before the first dose of IMP. * Receipt of corticosteroids within 14 days before the first dose of IMP. * Receipt of any small molecule IMP within 28 days or 5 half-lives, whichever is longer, before the first dose of IMP. * Receipt of concomitant medications, herbal supplements, or foods that are moderate or strong inhibitors of CYP3A4, CYP2D6, P-gp, or BCRP within a time period before the first dose of IMP based on the drug's elimination half-life, calculated as 5-7 half-lives (minimum 2 days), except for mechanism-based CYP3A4 inhibitors (e.g., clarithromycin, erythromycin), which require a 14-day washout to allow for enzyme re-synthesis. * Inadequate hepatic, renal and bone marrow function, receipt of a blood transfusion (blood or blood products) within 14 days before the first dose of IMP. * Persistent (\> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC \< 0.5 × 109/L or platelets \< 50 x 109/L). * History of cardiac dysfunction and/or presence of clinically significant cardiovascular disease * Has received a live virus vaccination within 28 days or less of planned treatment start. * Receipt of concomitant medications, herbal supplements, or foods that are moderate or strong inducers of CYP3A4, CYP2D6, P-gp, or BCRP within a time period before the first dose of IMP of 14 days, except St John's Wort, which requires a 21-day washout. Additional Module 1 inclusion criteria: 1\. Clinically confirmed locally advanced or metastatic solid malignancy for which there is no potentially curative treatment option.

Where Is This Study? (3 UK sites)

Research site 05

Manchester M20 4GJ, United Kingdom

Recruiting

Research site 04

Oxford OX37LE, United Kingdom

Recruiting

Research site 06

Sutton SM2 5PT, United Kingdom

Recruiting

How to Get in Touch

Clinical Operations

Sponsor contact

CONTACT

+353 1 5996873 hello@carricktherapeutics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08