Solid MalignanciesPhase 1/2NCT06600789
A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies
A Phase 1/2 study testing CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) in people with Solid Malignancies, run by Carrick Therapeutics Limited at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 16 Aug 2024to 14 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
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:
- Clinically confirmed locally advanced or metastatic solid malignancy for which there is no potentially curative treatment option.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Research site 03
Dallas, Texas, 75230-2571
- Recruiting
Research site 02
Fairfax, Virginia, 22031
- Recruiting
Research site 01
San Antonio, Texas, 78229
United Kingdom3 sites, 3 recruiting
- Recruiting
Research site 05
Manchester, M20 4GJ
- Recruiting
Research site 04
Oxford, OX37LE
- Recruiting
Research site 06
Sutton, SM2 5PT
About this study
Official title: A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination With Anticancer Treatments in Participants With Solid Malignancies
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.
Read the detailed description
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.
- Conditions
- Solid Malignancies
- Being tested
- CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg)
- Keywords
- Solid Malignancies, Cancer Treatment, First In Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. Different dosing schedules might be explored in cohorts (BID or intermitting dosing).
| Study group | Role | What they receive |
|---|---|---|
| Module 1 Part A (Dose Escalation) | Experimental | Experimental: Module 1 Part A (Dose Escalation) In Part A of Module 1, a minimum of 3 participants and maximum 6 evaluable participants with locally advanced or metastatic solid tumor malignancies will receive CT7439 capsules daily in ascending dose cohorts (maximum 6 cohorts) to identify the minimally biologically active dose (MBAD), planned tolerated dose (MTD) and/or maximum feasible dose (MFD). Receives: Drug: CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.
Measured: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days
Incidence and severity of treatment emergent Laboratory Abnormalities will be assessed as per CTCAE v5.0.
Measured: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days.
Change from Baseline in Eastern Cooperative Oncology Group Cooperative Oncology Group (ECOG) Performance scale.
ECOG has 6 levels (0 to 5). 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead.
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Systolic Blood Pressure as determined by blood pressure changes from baseline in systolic blood pressure (measured in mmHg)
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Diastolic Blood Pressure as determined by blood pressure changes from baseline in diastolic blood pressure (measured in mmHg)
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Heart Rate as determined by heart rate changes from baseline in beats per minute
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Body Temperature. as determined by body temperature changes from baseline in Celsius or Fahrenheit
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days) End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Respiratory Rate as determined by respiratory rate changes from baseline in breaths per minute
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Oxygen Saturation as determined by changes from baseline in %
Measured: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate
Measured: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): PR interval
Measured: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS complex
Measured: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals
Measured: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)
Measured: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Module 1 Part A additional primary outcome measures: Maximum tolerated dose (MTD) determination
Maximum tolerated dose (MTD) defined as the highest dose level at which ≤ 1/6 participants experience DLT in the first cycle. A minimum of 6 participants must be enrolled at the MTD level
Measured: Up to 28 days after the first dose of CT7439
Secondary outcomes (36)
CT7439 PK Plasma exposure: Cmax
Maximum PK Plasma concentrations and PK parameters for CT7439
Measured: PK plasma exposure Cmax: At the end of Cycle 0 Day 1 (cycle 0 is 2 days)
CT7439 PK plasma exposure: C-trough
CT7439 PK plasma parameters pre-dose
Measured: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months
Changes in CT or MRI tumor imaging to monitor anti-tumor activity
the imaging method of CT or MRI will be used at each subsequent visit
Measured: Screening, and from C1D1 every 8 weeks +/- 7 days up to Cycle 6 and End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
CT7439 PK urine exposure: Cmax
CT7439 PK concentration in urine
Measured: At Cycle 0, Day 1. Cycle 0 Day 1 is 24 hours.
Module 1 Part A additional secondary outcome measures - determination of recommended Phase 2 Dose (RP2D) and minimally biologically active dose (MBAD) of CT7439 when administered as monotherapy
the CT7439 MBAD is defined as the dose level that will show / achieve a proof of mechanism (PoM) ;a partial or complete RECIST v1.1 assessed response in at least one participant; a clinically significant reduction (in the opinion of the safety review committee (SRC), compared to baseline, in a tumor-specific marker measured in at least one participant
Measured: All cohorts. (each cohort is 6 cycles, each cycle is 28 days)
Module 1 Part A additional secondary outcome measures - Incidence of Dose Limited Toxicities (DLT)
number of safety events that are not clearly due to the underlying disease or extraneous causes lead to death, or discontinuation of drug treatment due to non-hematological toxicities (Grade 3 or higher) or hematological toxicities (Grade 3 or higher)
Measured: At end of Cycle 1 (each cycle is 28 days)
Module 1A secondary outcome measures- Renal clearance
Serum Chemistry creatinine clearance
Measured: Screening, Cycle 0 Day 1, Cycle 1 - Day 1,8,15, Cycle 2 - Day 1,15; Cycle 3 - Cycle 6 (28 day each cycle), End of Module/ End of Treatment (within 3 days after last CT7439 dose)
Module 1A secondary outcome measures - Pharmacodynamic evidence of the downstream effects of target engagement
Whole blood RNA assay
Measured: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
Module 1A secondary outcome measures - Incidence and prevalence of adverse events (AE) resulting in treatment withdrawal
number of adverse events leading to investigational medicinal drug (IMP) withdrawal
Measured: From 1st dose of IMP administration at Cycle 0 Day 1 throughout treatment Cycles 1, Cycle 2 - Cycles 6 ( each cycle 28 days) and until End of Treatment (within 3 days of last CT7439 dose) and End of Study (30+/- 7 days after the last CT7439 dose)
Module 1A secondary outcome measures - Best overall response (BOR)
BOR defined as the best response recorded from the randomization start until disease progression or death due to any cause
Measured: Up to 24 weeks
Module 1A Overall response rate (ORR)
ORR defined as the proportion of participants who achieved a complete response (CR) or partial response (PR) as per RECIST Version 1.1
Measured: Up to 24 weeks
Module 1A Duration of Response (DOR)
DOR defined as the time from the date of first documentation of objective tumor response (CR or PR) to the first documented objective tumor progression per RECIST version 1.1 or censored as defined for PFS
Measured: Up to 24 weeks
Module 1A PFS (Progression-free survival) assessment
PFS defined as the time from the first dose of IMP to the date of the first documentation of objective progression of disease (PD) per RECIST version 1.1
Measured: Up to 18 months
Cmax: maximum observed plasma concentration of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: COD1 from Time 0 to 48 hours
C24: plasma concentration at 24 hours of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: C0D1 from Time 0 to 24 hours
Tmax: time to maximum observed plasma concentration of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: COD1 from Time 0 to 48 hours
t½: apparent terminal half-life of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: COD1 from Time 0 to 48 hours
λz: apparent terminal elimination rate constant of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: COD1 from Time 0 to 48 hours
AUC0-24: area under the plasma concentration-time curve from Time 0 to 24 hours of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 0 from Time 0 to 24 hours
AUC0-48: area under the plasma concentration-time curve from Time 0 to 48 hours of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 0 from Time 0 to 48 hours
AUC0-t: area under the plasma concentration-time curve from Time 0 to the time of the last measurable concentration of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
AUC0-∞: area under the plasma concentration-time curve from Time 0 extrapolated to infinity of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
CL/F: apparent plasma clearance of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 0 from Time 0 to 48 hours
Vz/F: apparent volume of distribution of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 0 from Time 0 to 48 hours
MRT: mean residence time of CT7439 (single dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 0 from Time 0 to 48 hours
Css,max: maximum observed plasma concentration at steady state (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
Tss,max: Tmax at steady state (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
Css,min: minimum observed plasma concentration at steady state (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
AUCtau: area under the plasma concentration-time curve in the dosing interval (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
CLss/F: CL/F at steady state (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
MRTss: MRT at steady state (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
TCP: temporal change parameter (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
Rac: accumulation ratio (multiple dose)
Pharmacokinetic (PK) parameters calculated based on CT7439 plasma concentrations by using non-compartmental methods.
Measured: Cycle 2 Day 1
Amount excreted in urine (Ae) (per collection interval, cumulative and total)
Pharmacokinetic (PK) parameters calculated based on CT7439 urine concentrations by using non-compartmental methods.
Measured: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Percent or fraction of dose excreted in urine (Fe) (per collection interval, cumulative and total)
Pharmacokinetic (PK) parameters calculated based on CT7439 urine concentrations by using non-compartmental methods.
Measured: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Renal clearance (CLR)
Pharmacokinetic (PK) parameters calculated based on CT7439 urine concentrations by using non-compartmental methods.
Measured: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Aug 2024
- Primary completion14 Mar 2027 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carrick Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600789
- Sponsor's protocol ID
- CT7439_001
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2024
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular, Multi-Part, Multi-Arm, Phase 1/2 Study to Evaluate the Safety and Tolerability of CT7439 Alone and in Combination With Anticancer Treatments in Participants With Solid Malignancies
- ClinicalTrials.gov ID
- NCT06600789
- Acronym / sponsor ID
- CT7439_001
- Conditions
- Solid Malignancies
- Keywords
- Solid Malignancies, Cancer Treatment, First In Human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carrick Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 14 Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Module 1 Part A (Dose Escalation) | Experimental | Drug: CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg)Experimental: Module 1 Part A (Dose Escalation) In Part A of Module 1, a minimum of 3 participants and maximum 6 evaluable participants with locally advanced or metastatic solid tumor malignancies will receive CT7439 capsules daily in ascending dose cohorts (maximum 6 cohorts) to identify the minimally biologically active dose (MBAD), planned tolerated dose (MTD) and/or maximum feasible dose (MFD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg)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. Different dosing schedules might be explored in cohorts (BID or intermitting dosing). | Drug | Module 1 Part A (Dose Escalation) |
Primary outcome
Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.
Time frame: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days
Incidence and severity of treatment emergent Laboratory Abnormalities will be assessed as per CTCAE v5.0.
Time frame: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days.
Change from Baseline in Eastern Cooperative Oncology Group Cooperative Oncology Group (ECOG) Performance scale.
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
ECOG has 6 levels (0 to 5). 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead.
Systolic Blood Pressure as determined by blood pressure changes from baseline in systolic blood pressure (measured in mmHg)
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Diastolic Blood Pressure as determined by blood pressure changes from baseline in diastolic blood pressure (measured in mmHg)
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Heart Rate as determined by heart rate changes from baseline in beats per minute
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Body Temperature. as determined by body temperature changes from baseline in Celsius or Fahrenheit
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days) End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Respiratory Rate as determined by respiratory rate changes from baseline in breaths per minute
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Oxygen Saturation as determined by changes from baseline in %
Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate
Time frame: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): PR interval
Time frame: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS complex
Time frame: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals
Time frame: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)
Time frame: From baseline to end of Cycle 6 (each cycle is 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
Module 1 Part A additional primary outcome measures: Maximum tolerated dose (MTD) determination
Time frame: Up to 28 days after the first dose of CT7439
Maximum tolerated dose (MTD) defined as the highest dose level at which ≤ 1/6 participants experience DLT in the first cycle. A minimum of 6 participants must be enrolled at the MTD level
36 secondary outcomes
CT7439 PK Plasma exposure: Cmax
Time frame: PK plasma exposure Cmax: At the end of Cycle 0 Day 1 (cycle 0 is 2 days)
CT7439 PK plasma exposure: C-trough
Time frame: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months
Changes in CT or MRI tumor imaging to monitor anti-tumor activity
Time frame: Screening, and from C1D1 every 8 weeks +/- 7 days up to Cycle 6 and End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose)
CT7439 PK urine exposure: Cmax
Time frame: At Cycle 0, Day 1. Cycle 0 Day 1 is 24 hours.
Module 1 Part A additional secondary outcome measures - determination of recommended Phase 2 Dose (RP2D) and minimally biologically active dose (MBAD) of CT7439 when administered as monotherapy
Time frame: All cohorts. (each cohort is 6 cycles, each cycle is 28 days)
Module 1 Part A additional secondary outcome measures - Incidence of Dose Limited Toxicities (DLT)
Time frame: At end of Cycle 1 (each cycle is 28 days)
Module 1A secondary outcome measures- Renal clearance
Time frame: Screening, Cycle 0 Day 1, Cycle 1 - Day 1,8,15, Cycle 2 - Day 1,15; Cycle 3 - Cycle 6 (28 day each cycle), End of Module/ End of Treatment (within 3 days after last CT7439 dose)
Module 1A secondary outcome measures - Pharmacodynamic evidence of the downstream effects of target engagement
Time frame: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
Module 1A secondary outcome measures - Incidence and prevalence of adverse events (AE) resulting in treatment withdrawal
Time frame: From 1st dose of IMP administration at Cycle 0 Day 1 throughout treatment Cycles 1, Cycle 2 - Cycles 6 ( each cycle 28 days) and until End of Treatment (within 3 days of last CT7439 dose) and End of Study (30+/- 7 days after the last CT7439 dose)
Module 1A secondary outcome measures - Best overall response (BOR)
Time frame: Up to 24 weeks
Module 1A Overall response rate (ORR)
Time frame: Up to 24 weeks
Module 1A Duration of Response (DOR)
Time frame: Up to 24 weeks
Module 1A PFS (Progression-free survival) assessment
Time frame: Up to 18 months
Cmax: maximum observed plasma concentration of CT7439 (single dose)
Time frame: COD1 from Time 0 to 48 hours
C24: plasma concentration at 24 hours of CT7439 (single dose)
Time frame: C0D1 from Time 0 to 24 hours
Tmax: time to maximum observed plasma concentration of CT7439 (single dose)
Time frame: COD1 from Time 0 to 48 hours
t½: apparent terminal half-life of CT7439 (single dose)
Time frame: COD1 from Time 0 to 48 hours
λz: apparent terminal elimination rate constant of CT7439 (single dose)
Time frame: COD1 from Time 0 to 48 hours
AUC0-24: area under the plasma concentration-time curve from Time 0 to 24 hours of CT7439 (single dose)
Time frame: Cycle 0 from Time 0 to 24 hours
AUC0-48: area under the plasma concentration-time curve from Time 0 to 48 hours of CT7439 (single dose)
Time frame: Cycle 0 from Time 0 to 48 hours
AUC0-t: area under the plasma concentration-time curve from Time 0 to the time of the last measurable concentration of CT7439 (single dose)
Time frame: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
AUC0-∞: area under the plasma concentration-time curve from Time 0 extrapolated to infinity of CT7439 (single dose)
Time frame: From first cycle to end of Cycle 6. (each cycle is 28 days). Up to 6 months.
CL/F: apparent plasma clearance of CT7439 (single dose)
Time frame: Cycle 0 from Time 0 to 48 hours
Vz/F: apparent volume of distribution of CT7439 (single dose)
Time frame: Cycle 0 from Time 0 to 48 hours
MRT: mean residence time of CT7439 (single dose)
Time frame: Cycle 0 from Time 0 to 48 hours
Css,max: maximum observed plasma concentration at steady state (multiple dose)
Time frame: Cycle 2 Day 1
Tss,max: Tmax at steady state (multiple dose)
Time frame: Cycle 2 Day 1
Css,min: minimum observed plasma concentration at steady state (multiple dose)
Time frame: Cycle 2 Day 1
AUCtau: area under the plasma concentration-time curve in the dosing interval (multiple dose)
Time frame: Cycle 2 Day 1
CLss/F: CL/F at steady state (multiple dose)
Time frame: Cycle 2 Day 1
MRTss: MRT at steady state (multiple dose)
Time frame: Cycle 2 Day 1
TCP: temporal change parameter (multiple dose)
Time frame: Cycle 2 Day 1
Rac: accumulation ratio (multiple dose)
Time frame: Cycle 2 Day 1
Amount excreted in urine (Ae) (per collection interval, cumulative and total)
Time frame: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Percent or fraction of dose excreted in urine (Fe) (per collection interval, cumulative and total)
Time frame: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Renal clearance (CLR)
Time frame: Cycle 0, Day 1: 0-4 hr, 4-8 hr and 8-24 hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) in people with Solid Malignancies, run by Carrick Therapeutics Limited at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (+353 1 5996873, hello@carricktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0. (time frame: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days). The study lists 15 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 3 Sep 2026; AzTrials last refreshed its copy on 5 Nov 2026.