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Wnt Inhibitor

LGK974 for Cancer

Houston, TX

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with specified cutaneous melanoma conditions are eligible for LGK974 with PDR001 dose expansion

Patients with specified cancers previously treated with anti-PD-1 therapy and whose best response was progressive disease are eligible for LGK974 with PDR001 dose escalation

Must not have

Malignant disease other than that being treated in this study

Osteoporosis, osteopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 61 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called LGK974 to see if it is safe and effective in treating adults with cancer that has progressed despite standard therapy or for which no effective standard therapy exists.

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Who is the study for?

Adults with advanced cancers like melanoma, cervical, esophageal, colorectal, and breast cancer that have worsened despite treatment or lack a standard therapy. Eligible participants include those with certain genetic mutations or who've had specific prior treatments. People with heart issues, bone diseases, other active cancers, untreated brain metastases, severe autoimmune conditions or allergies to monoclonal antibodies can't join.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosing of LGK974 alone and combined with PDR001 in patients. It aims to determine how well these drugs can be tolerated by individuals whose cancers are reliant on Wnt ligands for growth and who have exhausted other treatment options.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs; gastrointestinal disturbances which could affect drug absorption; bone-related issues; and possibly increased susceptibility to infections due to immune response alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of skin cancer eligible for a certain treatment.

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My cancer worsened after anti-PD-1 therapy, so I can try LGK974 with PDR001.

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My advanced cancer has worsened despite treatment, or there's no effective treatment for it.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any cancer other than the one being treated in this study.

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I have been diagnosed with osteoporosis or osteopenia.

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I have had a recent bone fracture or a fracture caused by disease.

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My heart does not function properly.

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I have brain metastases that have not been treated.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 61 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~61 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 61 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLTs) during the first cycle of LGK974 treatment and during the first 2 cycles of LGK974 in combination with PDR001

Secondary study objectives

Absorportion and plasma concentrations of PDR001

Absorption and plasma concentrations of LGK974

Overall response rate of tumor

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