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

NCT ID: NCT06600789

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2026-05-22

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.

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until evidence of disease progression, unacceptable toxicities, the participant withdraws their informed consent or is withdrawn from the study, or completion of the primary study analysis.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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Module 1 Part A (Dose Escalation)

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

Eligibility Criteria

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.

1. Clinically confirmed locally advanced or metastatic solid malignancy for which there is no potentially curative treatment option.

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 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carrick Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research site 03

Dallas, Texas, United States

Site Status: RECRUITING

Research site 01

San Antonio, Texas, United States

Site Status: RECRUITING

Research site 02

Fairfax, Virginia, United States

Site Status: RECRUITING

Research site 05

Manchester, , United Kingdom

Site Status: RECRUITING

Research site 04

Oxford, , United Kingdom

Site Status: RECRUITING

Research site 06

Sutton, , United Kingdom

Site Status: RECRUITING

Countries

United States; United Kingdom

Central Contacts

Clinical Operations

Role: CONTACT

hello@carricktherapeutics.com

+353 1 5996873

Other Identifiers

CT7439_001

Identifier Type: -

Identifier Source: org_study_id