A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies
ConditionSolid Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarrick Therapeutics Limited
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CT7439 Capsules (0.5 mg, 1mg, 3mg)
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov