Testing CT7439 for treating solid tumors

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 study is testing a new drug called CT7439 to see if it is safe and effective for people with solid tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Carrick Therapeutics Limited (industry)
• Locations: 6 sites (Dallas, Texas and 5 other locations)
• Trial ID: NCT06600789 on ClinicalTrials.gov

What this trial studies

This modular, multi-part Phase 1/2 study evaluates the safety and tolerability of CT7439 in participants with solid malignancies. Initially, it focuses on CT7439 as a monotherapy through a dose escalation approach to determine the minimum biologically active dose and maximum tolerated dose. Participants will be monitored for safety and tolerability, and the study may include additional cohorts for specific sub-populations based on protocol amendments. The study aims to gather data on the pharmacokinetics and pharmacodynamics of CT7439.

Who should consider this trial

Good fit: Ideal candidates include individuals with confirmed solid malignancies who meet specific inclusion criteria and are willing to comply with study protocols.

Not a fit: Patients with solid malignancies who do not meet the eligibility criteria or have rapidly progressing disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with solid malignancies.

How similar studies have performed: Other studies have shown promise with similar first-in-human approaches, but the specific use of CT7439 is novel.

Eligibility 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 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.

Additional Module 1 inclusion criteria:

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

Where this trial is running

Dallas, Texas and 5 other locations

• Research site 03 — Dallas, Texas, United States (RECRUITING)
• Research site 01 — San Antonio, Texas, United States (RECRUITING)
• Research site 02 — Fairfax, Virginia, United States (RECRUITING)
• Research site 05 — Manchester, United Kingdom (RECRUITING)
• Research site 04 — Oxford, United Kingdom (RECRUITING)
• Research site 06 — Sutton, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Clinical Operations

Conditions: Solid Malignancies, Cancer Treatment, First In Human