RECRUITING

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

Conditions

Solid Malignancies Cancer Treatment First In Human

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08-16

Study Completion:2026-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06600789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Clinical Operations

CONTACT

+353 1 5996873

hello@carricktherapeutics.com

Study Locations (Sites)

Research site 03

Dallas, Texas, 75230-2571

United States

Research site 01

San Antonio, Texas, 78229

United States

Research site 02

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Carrick Therapeutics Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16

Study Completion Date2026-05-22

Study Record Updates

Study Start Date2024-08-16

Study Completion Date2026-05-22

Terms related to this study

Keywords Provided by Researchers

Solid Malignancies
Cancer Treatment
First In Human

Additional Relevant MeSH Terms

Solid Malignancies