A Modular Phase 1/2 Study with CT7439 in Participants with Solid Malignancies

DRUG

CT7439 Capsules (0.5 mg, 1mg, 3mg)

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.

Incidence and severity of treatment emergent adverse events will be assessed as per CTCAE v5.0.

Time frame: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days

Incidence and severity of treatment emergent Laboratory Abnormalities will be assessed as per CTCAE v5.0.

Time frame: From first dosing at Cycle 0 to until 30 days after the last dose at Cycle 6. Each cycle is 28 days.

Change from Baseline in Eastern Cooperative Oncology Group Cooperative Oncology Group (ECOG) Performance scale.

Time frame: Screening, Cycle 0 Day 1, Cycle 1- Days 1,8,15; Cycle 2 -Days 1,15; Cycle 3 Day 1 - Cycle 6 Day 1 (each cycle 28 days); End of Treatment (within 3 days after last CT7439 dose) and End of Study (30 +/-7 days after the last CT7439 dose administration)

ECOG has 6 levels (0 to 5). 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead.

Systolic Blood Pressure as determined by blood pressure changes from baseline in systolic blood pressure (measured in mmHg)

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Diastolic Blood Pressure as determined by blood pressure changes from baseline in diastolic blood pressure (measured in mmHg)

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Heart Rate as determined by heart rate changes from baseline in beats per minute

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Body Temperature. as determined by body temperature changes from baseline in Celsius or Fahrenheit

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Respiratory Rate as determined by respiratory rate changes from baseline in breaths per minute

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Oxygen Saturation as determined by changes from baseline in %

Time frame: Screening, Cycle 0 - Days 1 and Day 2; Cycle 1 - Days 1,8,15; Cycle 2 Day 1 - Cycle 6 Day 1 (each cycle 28 days)

Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate

Time frame: From baseline to end of Cycle 6. Each cycle is 28 days

Change from Baseline in 12-lead Electrocardiogram (ECG): PR interval

Time frame: From baseline to end of Cycle 6. Each cycle is 28 days

Change from Baseline in 12-lead Electrocardiogram (ECG): QRS complex

Time frame: From baseline to end of Cycle 6. Each cycle is 28 days

Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals

Time frame: From baseline to end of Cycle 6. Each cycle is 28 days

Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)

Time frame: From baseline to end of Cycle 6. Each cycle is 28 days

Module 1 Part A additional primary outcome measures: Maximum tolerated dose (MTD) determination

Time frame: Up to 28 days after the first dose of CT7439

Maximum tolerated dose (MTD) defined as the highest dose level at which ≤ 1/6 participants experience DLT in the first cycle. A minimum of 6 participants must be enrolled at the MTD level

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.