DKY709 + PDR001 for Cancer

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests DKY709 alone and with PDR001 in patients with certain cancers who didn't respond to previous treatments. It aims to see if these drugs can improve the immune system's ability to fight cancer.

Research Team

Eligibility Criteria

Adults (≥18 years) with advanced cancers like NSCLC, melanoma, NPC, mssCRC, or TNBC who have progressed after standard therapy or are intolerant to it. Participants must have measurable disease and be willing to undergo tumor biopsies. Excluded are those with significant heart issues, severe allergies to study drugs' ingredients, certain abnormal lab values, symptomatic CNS metastases or recent cardiac events.

Inclusion Criteria

I am fully active and can carry on all my pre-disease activities without restriction.

For the additional part of the study, patients must have one of the following: non-small cell lung cancer with a history of PD-L1 levels of at least 1% and disease progression after at least 4 months of stable or improved condition with previous anti-PD-L1 treatment; previously treated cutaneous melanoma with documented disease progression after anti-PD-1/PD-L1 therapy; nasopharyngeal carcinoma (NPC) without prior anti-PD-1/PD-L1 therapy; microsatellite stable colorectal cancer (mssCRC) without prior anti-PD-1/PD-L1 therapy; triple-negative breast cancer (TNBC) without prior anti-PD-1/PD-L1 therapy.

My advanced cancer has worsened after standard treatment, or I can't tolerate it, and no other standard treatments work for me.

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Exclusion Criteria

I do not have serious heart problems or recent heart attacks.

Your kidney function, liver function, and blood cell counts need to be within certain ranges to qualify for the study.

I have brain metastases that are stable, and I haven't taken steroids for 2 weeks.

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Treatment Details

Interventions

DKY709 (Other)
PDR001 (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the safety and effectiveness of DKY709 alone and in combination with PDR001 for treating various advanced solid tumors. It's a phase I/Ib study that includes an initial dose escalation to find the maximum tolerated dose followed by expansion at this dose to further evaluate the treatments.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: DKY709 + PDR001Experimental Treatment2 Interventions

Combination therapy with DKY709 and PDR001

Group II: DKY709Experimental Treatment1 Intervention

DKY709 monotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine