Study 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.
Eligible Conditions
- Esophageal Squamous Cell Carcinoma
- BRAF Mutant Colorectal Cancer
- Squamous Cell Carcinoma of the Lung
- Squamous Cell Head and Neck Cancers
- Melanoma
- Pancreatic Cancer
- Breast Cancer
- Cervical Squamous Cell Carcinoma
Treatment Effectiveness
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 61 months
34 months
Maximum Tolerated Dose or Recommended Dose for Expansion of LGK974 as a single agent or in combination with PDR001 in patients treated
61 months
Absorportion and plasma concentrations of PDR001
Absorption and plasma concentrations of LGK974
Biomarkers related to immunomodulation
Biomarkers related to the Wnt pathway
Overall response rate of tumor
PD related to the Wnt pathway
Type and category of study drug related adverse events (AE)
Trial Safety
Trial Design
2 Treatment Groups
LGK974
1 of 2
LGK974 in combination with PDR001
1 of 2
Experimental Treatment
185 Total Participants · 2 Treatment Groups
Primary Treatment: LGK974 · No Placebo Group · Phase 1
LGK974
Drug
Experimental Group · 1 Intervention: LGK974 · Intervention Types: DrugLGK974 in combination with PDR001Experimental Group · 2 Interventions: LGK974, PDR001 · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 61 months
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,718 Previous Clinical Trials
3,524,834 Total Patients Enrolled
4 Trials studying Esophageal Squamous Cell Carcinoma
412 Patients Enrolled for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients with BRAF V600-mutant melanoma must have also received and been failed by prior systemic therapy with BRAF V600 inhibitor, with or without a MEK inhibitor.
You have cutaneous melanoma with acquired resistance to prior anti-PD-1 therapy, defined as progressive disease following response (PR or CR) or following stable disease for > 4 months.
References
- Rodon, Jordi, Guillem Argilés, Roisin M. Connolly, Ulka Vaishampayan, Maja de Jonge, Elena Garralda, Marios Giannakis, et al.. 2021. “Phase 1 Study of Single-agent WNT974, a First-in-class Porcupine Inhibitor, in Patients with Advanced Solid Tumours”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/s41416-021-01389-8.
- Rodon J, Argiles G, Connolly RM, Vaishampayan U, de Jonge M, Garralda E, Giannakis M, Smith DC, Dobson JR, McLaughlin ME, Seroutou A, Ji Y, Morawiak J, Moody SE, Janku F. Phase 1 study of single-agent WNT974, a first-in-class Porcupine inhibitor, in patients with advanced solid tumours. Br J Cancer. 2021 Jul;125(1):28-37. doi: 10.1038/s41416-021-01389-8. Epub 2021 May 3.
- 2011. "A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01351103.
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Conditions
Cancer Related
Treatments