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

NCT06600789 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CT7439_001
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Solid Malignancies

Keywords

Solid Malignancies; Cancer Treatment; First In Human

Outcome Measures

Primary Outcomes (15)

• Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.

  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.

  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.

  Screening, Cycle 0 Day 1, Cycle 1- Days 1,8,15; Cycle 2 -Days 1,15; Cycle 3 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 administration)

• Systolic Blood Pressure as determined by blood pressure changes from baseline in systolic blood pressure (measured in mmHg)

  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)

• Diastolic Blood Pressure as determined by blood pressure changes from baseline in diastolic blood pressure (measured in mmHg)

  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)

• Heart Rate as determined by heart rate changes from baseline in beats per minute

  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)

• Body Temperature. as determined by body temperature changes from baseline in Celsius or Fahrenheit

  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)

• Respiratory Rate as determined by respiratory rate changes from baseline in breaths per minute

  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)

• Oxygen Saturation as determined by changes from baseline in %

  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)

• Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate

  From baseline to end of Cycle 6. Each cycle is 28 days

• Change from Baseline in 12-lead Electrocardiogram (ECG): PR interval

  From baseline to end of Cycle 6. Each cycle is 28 days

• Change from Baseline in 12-lead Electrocardiogram (ECG): QRS complex

  From baseline to end of Cycle 6. Each cycle is 28 days

• Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals

  From baseline to end of Cycle 6. Each cycle is 28 days

• Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)

  From baseline to end of Cycle 6. Each cycle is 28 days

• 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

  Up to 28 days after the first dose of CT7439

Secondary Outcomes (13)

• CT7439 PK Plasma exposure: Cmax

  PK urine exposure Cmax: At the end of Cycle 0 Day 1 (cycle 0 is 2 days)

• CT7439 PK plasma exposure: C-trough

  Cycle 0 Day 2, Cycle 1 - Days 1, 8, 15; Cycle 2 Day 2; on Cycle 3 day 1 and upwards on Day 1 of every other cycle (each cycle is 28 days)

• Changes in CT or MRI tumor imaging to monitor anti-tumor activity

  Screening, Cycles 3 Day 1 to Cycle 6 Day 1 (28 days each cycle) and End of Module/ End of Treatment visit (within 3 days after last CT7439 dose)

• CT7439 PK urine exposure: Cmax

  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

  from cohort 1 to cohort 6. (each cohort is 6 cycles , each cycle is 28 days)

Study Arms (1)

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), maximum tolerated dose (MTD) and/or maximum feasible dose (MFD).

Drug: CT7439 Capsules (0.5 mg, 1mg, 3mg)

Interventions

CT7439 Capsules (0.5 mg, 1mg, 3mg) 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.

Module 1 Part A (Dose Escalation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 enrollment.
• 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 medication, herbal supplement, or food that is a moderate and/or strong inhibitor or inducer of CYP3A4,,strong inhibitor or inducer of CYP2D6 or P-gp or inhibitor of BCRP within 21 days before the first dose of IMP.
• 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.

Sponsors & Collaborators

• Carrick Therapeutics Limited: lead

Study Sites (6)

Research site 03

Dallas, Texas, 75230-2571, United States

RECRUITING

Research site 01

San Antonio, Texas, 78229, United States

RECRUITING

Research site 02

Fairfax, Virginia, 22031, United States

RECRUITING

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

Central Study Contacts

Clinical Operations

CONTACT

+353 1 5996873; hello@carricktherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: August 16, 2024
• Primary Completion: April 22, 2026
• Study Completion (Estimated): May 22, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); GB (3)