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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Carrick Therapeutics Limited
Study ID
NCT06600789
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT7439 Capsules (0.5 mg, 1mg, 3mg, 10mg, 15mg, 20mg) — DRUG
    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. Different dosing schedules might be explored in cohorts (BID or intermitting dosing).

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Aug 16, 2024
Status verified
Aug 2026
Primary completion
Mar 14, 2027
Completion
Mar 14, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Part A (Dose Escalation)
    Experimental: Module 1 Part A (Dose Escalation) In Part A of Module 1, a minimum of 3 participants and maximum 6 evaluable participants with locally advanced or metastatic solid tumor malignancies will receive CT7439 capsules daily in ascending dose cohorts (maximum 6 cohorts) to identify the minimally biologically active dose (MBAD), planned tolerated dose (MTD) and/or maximum feasible dose (MFD).

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research site 03DallasTexas75230-2571-
Research site 01San AntonioTexas78229-
Research site 02FairfaxVirginia22031-

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