A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors

Sponsor
LARKSPUR BIOSCIENCES, INC.
Study ID
NCT07498725
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • LRK-4189 escalation — DRUG
    LRK-4189 at various doses
  • LRK-4189 expansion — DRUG
    LRK-4189 MTD
  • LRK-4189 optimization — DRUG
    LRK-4189 2 distinct doses
  • Chemo — DRUG
    Standard of care

Study Details

The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189. The main questions it aims to answer are: Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors? Participants will: * Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years. * Visit the clinic once every week for checkups and tests.

Key Dates

First listed
Mar 27, 2026
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1/1b escalation
  • Experimental: Part 2 expansion
  • Experimental: Part 2b expansion
  • Experimental: Part 3 optimization

Primary Outcome Measure

Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type [ Time Frame: From enrollment to the end of the first treatment cycle (each cycle is 21 days) ]

Central Contacts

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