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

ConditionNeoplasms
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLARKSPUR BIOSCIENCES, INC.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.

Cancer can be measured on scans, such as CT or MRI.

Disqualifiers

Unable to swallow the study medication or your body cannot absorb it.

Have had a serious allergic reaction to LRK-4189 or any of its ingredients.

Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.

Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Part 1/1b escalationExperimental treatment 1 intervention
Group B: Part 2 expansionExperimental treatment 1 intervention
Group C: Part 2b expansionExperimental treatment 2 interventions
Group D: Part 3 optimizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: