Actively Recruiting
A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies
Led by Carrick Therapeutics Limited · Updated on 2025-11-03
50
Participants Needed
6
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically or cytologically confirmed diagnosis of malignant disease evaluable by RECIST v1.1
- Signed informed consent and willingness to comply with all study visits, treatments, tests, and procedures
- ECOG performance status of 2 or less with no worsening in the last 2 weeks
- Ability to take oral medications and willingness to record daily adherence
- Women of non-childbearing potential or willing to use effective contraception during study and for at least 33 days after last dose
- Sexually active men willing to use condoms during study and for at least 93 days after last dose and refrain from sperm donation
- Estimated life expectancy of at least 3 months as judged by investigator
- Clinically confirmed locally advanced or metastatic solid malignancy with no curative treatment option
You will not qualify if you...
- Prior therapy with a specific CDK12/13 inhibitor at any time before first dose
- Other active or treated malignancies within past 3 years except cervical intraepithelial neoplasia and non-melanoma skin cancer
- Unresolved toxicity from prior therapy of Grade 2 or higher (except alopecia)
- Active or history of autoimmune disease
- Current or past central nervous system metastases
- Active infection requiring systemic treatment within 14 days before first dose
- Severe or uncontrolled medical or psychiatric conditions
- HIV infection unless on anti-retroviral therapy for at least 28 days with no opportunistic infection in past 12 months
- Active hepatitis B or C infection unless under suppressive therapy or with low viral load
- Pregnant or breastfeeding
- Cytotoxic or non-cytotoxic cancer treatment within 28 days before first dose
- Corticosteroid use within 14 days before first dose
- Use of other investigational drugs within 28 days or 5 half-lives before first dose
- Use of medications or supplements that strongly affect CYP3A4, CYP2D6, P-gp, or BCRP within 21 days before first dose
- Inadequate liver, kidney, or bone marrow function or recent blood transfusion within 14 days
- Persistent severe pancytopenia due to prior therapy
- History of cardiac dysfunction or significant cardiovascular disease
- Live virus vaccination within 28 days before planned treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Research site 03
Dallas, Texas, United States, 75230-2571
Actively Recruiting
2
Research site 01
San Antonio, Texas, United States, 78229
Actively Recruiting
3
Research site 02
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Research site 05
Manchester, United Kingdom, M20 4GJ
Actively Recruiting
5
Research site 04
Oxford, United Kingdom, OX37LE
Actively Recruiting
6
Research site 06
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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