Trial Title:
A Modular Phase 1/2 Study with CT7439 in Participants with Solid Malignancies
NCT ID:
NCT06600789
Condition:
Solid Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Malignancies
Cancer Treatment
First In Human
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CT7439 Capsules (0.5 mg, 1mg, 3mg)
Description:
CT7439 capsules administered by mouth once a day as monotherapy with a single starting
dose of 1mg in Cohort 1 on Cycle 0 Day 1, followed by a minimum 48 hours treatment -free
period before continuous daily dosing in cycles of 28 days (Cycle1 onwards) until DLT or
disease progression is observed.
Arm group label:
Module 1 Part A (Dose Escalation)
Summary:
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.
Detailed description:
This study will initially evaluate CT7439 as a monotherapy in participants with locally
advanced or metastatic solid malignancies, i.e., Module 1, which includes dose escalation
cohort (Part A).
- Part A of Module 1: a First-in Human dose escalation investigating the safety and
tolerability of CT7439 to identify the minimum biologically active dose (MBAD) and
either maximum tolerated dose (MTD) or maximum feasible dose (MFD) of CT7439 when
dosed as monotherapy. SRC, consisting of study investigators and sponsor medical
personnel, will be formed to monitor the safety, tolerability, PK, and PDc data
during this part of the study. In Part A, cohorts (maximum 6) will be opened
sequentially following review from the SRC who will make recommendations on CT7439
dosage selection for subsequent cohorts. Participants will continue to receive IMP
until evidence of disease progression, unacceptable toxicities, the participant
withdraws their informed consent or is withdrawn from the study, or completion of
the primary study analysis.
Further cohort(s) of specific participant sub-populations may be initiated in Module 1
following approval of a protocol amendment.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research site 03
Address:
City:
Dallas
Zip:
75230-2571
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site 01
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site 02
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Research site 05
Address:
City:
Manchester
Zip:
M20 4GJ
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research site 05
Address:
City:
Oxford
Zip:
OX37LE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research site 06
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
August 16, 2024
Completion date:
May 22, 2026
Lead sponsor:
Agency:
Carrick Therapeutics Limited
Agency class:
Industry
Source:
Carrick Therapeutics Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06600789
