Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    380
  • sponsor
    Novartis Pharmaceuticals
Updated on 6 June 2022
cancer
measurable disease
melanoma skin
metastasis
progressive disease
programmed cell death 1 ligand 1
solid tumour
core needle biopsy
malignant melanoma of skin

Summary

This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.

Details
Condition Carcinoma, Non-Small-Cell Lung, Melanoma, Nasopharyngeal Carcinoma, Microsatellite Stable Colorectal Cancer, Triple Negative Breast Cancer
Treatment PDR001, DKY709
Clinical Study IdentifierNCT03891953
SponsorNovartis Pharmaceuticals
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study
Patients must be ≥18 years of age at the time of informed consent form (ICF) signature
Patients with advanced/metastatic cancer who have progressed despite having received standard therapy in the metastatic setting or are intolerant to standard therapy, and for whom no effective standard therapy is available
In expansion: patient with measurable disease as determined by RECIST version 1.1
Dose escalation, patients must fit into one of the following groups
NSCLC, previously treated with an anti-PD-1/PD-L1 therapy
Cutaneous Melanoma, previously treated with an anti-PD-1/PD-L1 therapy
NPC
Dose expansion part, patients must fit into one of the following groups
NSCLC with historic documentation of PD-L1 ≥ 1%. Patients must have progressive disease after having experienced at least 4 months of investigator-assessed disease stability or response on prior anti-PD-L1-containing therapy
Cutaneous Melanoma, previously treated with anit-PD-1/PD-L1 therapy. Patients should have documented progression following anti-PD-1/PD-L1 therapy
NPC, naive to anti-PD-1/PD-L1 therapy
mssCRC, naive to anti-PD-1/PD-L1 therapy
TNBC, naive to anti-PD-1/PD-L1 therapy 6. ECOG Performance Status ≤ 1 7. Patients must have a site of disease amenable to core needle biopsy, and be a
candidate for tumor biopsy according to the treating institution's guidelines
Patients must be willing to undergo a new tumor biopsy at baseline, and during
therapy on the study. Exceptions may be considered after documented discussion
with Novartis

Exclusion Criteria

Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 2 weeks prior to study entry. Patients with treated brain metastases should be neurologically stable for at least 4 weeks prior to study entry and off steroids for at least 2 weeks before administration of any study treatment
History of severe hypersensitivity reactions to any ingredient of study drug(s) or other mAbs and/or their excipients
Patient with out of range laboratory values defined as
Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 40 mL/min
Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
Alanine aminotransferase (ALT) > 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if ALT > 5 x ULN
Aspartate aminotransferase (AST) > 3 x ULN, except for patients that have tumor involvement of the liver, who are excluded if AST > 5 x ULN
Absolute neutrophil count (ANC) < 1.0 x 109/L
Platelet count < 75 x 109/L (growth factor or transfusion support may not be used to meet entry criterion)
Hemoglobin (Hgb) < 8 g/dL (growth factor or transfusion support may not be used to meet entry criterion)
On screening: QTcF > 450 msec (male), or > 460 msec (female)
QTc not assessable
Magnesium, calcium or phosphate abnormality CTCAE > grade 1
Congenital long QT syndrome
Potassium abnormality CTCAE ≥ grade 1; supplementation to meet eligibility criteria is acceptable
History of familial long QT syndrome or known family history of as Torsades de Pointes
Clinically significant cardiac disease or impaired cardiac function, including any of
Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry
the following
Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2), uncontrolled hypertension or clinically significant arrhythmia
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