Actively Recruiting
A Modular Phase 1/2 Study Evaluating Safety and Tolerability of CT7439 Alone and With Anticancer Treatments in Participants With Solid Malignancies
Led by Carrick Therapeutics Limited · Updated on 2025-11-03
50
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying CT7439, an experimental drug, in adults with locally advanced or metastatic solid cancers to assess its safety and tolerability. This Phase 1/2, modular, multi-part study focuses on first-in-human dose escalation to find the appropriate doses when given alone or combined with other anticancer treatments. The study aims to identify the minimum biologically active dose and maximum tolerated or feasible dose of CT7439. Participants will receive CT7439 capsules by mouth once daily, starting with a single 1 mg dose followed by a treatment-free period before continuous dosing in 28-day cycles. Dose escalation cohorts will be sequentially evaluated, with up to six cohorts planned. Participants will continue treatment until disease progression, unacceptable side effects, withdrawal, or study completion. Further cohorts may be added to explore specific patient subgroups. During the study, participants will undergo regular safety and health assessments, including monitoring of vital signs, blood tests, ECGs, and tumor imaging using CT or MRI. Researchers will track treatment side effects and measure drug levels in the blood and urine. The study includes monitoring from the first dose through multiple 28-day cycles, with follow-up visits after treatment ends to evaluate overall response, progression-free survival, and other safety outcomes.
CONDITIONS
Brief 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 malignant disease evaluable by RECIST v1.1
- Signed informed consent and willingness to comply with all study procedures
- ECOG performance status of 2 or less without deterioration in past 2 weeks
- Ability to take oral medications and record daily adherence
- Women of non-childbearing potential or using effective contraception during study and 33 days after last dose
- Sexually active men willing to use condoms and refrain from sperm donation during study and 93 days after last dose
- 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 any CDK12/13 inhibitor
- Other active malignancies treated or active within past 3 years except certain skin and cervical conditions
- Unresolved toxicity grade 2 or higher from prior therapy (except alopecia)
- Active or history of autoimmune disease
- Current or prior central nervous system metastases
- Active infection requiring systemic antimicrobial treatment within 14 days before study drug
- Severe or uncontrolled medical or psychiatric conditions
- HIV infection without stable anti-retroviral therapy or recent opportunistic infection
- Active hepatitis B or C infection unless controlled by therapy or viral load undetectable
- Pregnant or breastfeeding participants
- Cytotoxic or non-cytotoxic cancer treatment within 28 days before first study dose
- Corticosteroid use within 14 days before first study dose
- Use of certain medications affecting drug metabolism within 21 days before first dose
- Inadequate liver, kidney, or bone marrow function or recent blood transfusion
- Persistent severe pancytopenia unrelated to disease
- History of significant cardiac or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each, continuing until disease progression or unacceptable toxicities
Participants receive CT7439 capsules by mouth once daily in cycles of 28 days. The initial dose is followed by a minimum 48-hour treatment-free period before continuous daily dosing. Treatment continues until disease progression, unacceptable toxicities, withdrawal, or study completion.
Multiple visits including baseline and frequent monitoring visits during treatment cycles (Cycle 0 Day 1 and 2; Cycle 1 Days 1, 8, 15; Cycle 2 Days 1, 15; and Cycle 3 to Cycle 6 Day 1)
Duration - 30 days after last dose
Participants are monitored for safety and treatment outcomes for 30 days after the last dose of CT7439.
1 visit within 30 days after last dose
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
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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