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

Send

Updated on 6 June 2022

See if I qualify

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 Identifier	NCT03891953
Sponsor	Novartis Pharmaceuticals
Last Modified on	6 June 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

programmed cell death 1 ligand 1

solid tumour

core needle biopsy

malignant melanoma of skin

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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