What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving immune checkpoint inhibitors like PDR001 (anti-PD-1 monoclonal antibody), can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Targeted therapies for HER2-positive breast cancer, such as trastuzumab and T-DM1, often result in cardiotoxicity, infusion reactions, and hematologic toxicities. Patients should be closely monitored for these side effects to manage and mitigate potential complications effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapy and targeted therapy drugs for the treatment of breast cancer. Pembrolizumab, an anti-PD-1 monoclonal antibody similar to PDR001, has been approved for use in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1. Additionally, trastuzumab, a monoclonal antibody targeting HER2, and its conjugates like ado-trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan, have been approved for HER2-positive breast cancer. These treatments highlight the evolving landscape of targeted and immunotherapy options for breast cancer.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, which has shown efficacy in triple-negative breast cancer. 2) Trastuzumab deruxtecan, another antibody-drug conjugate targeting HER2, effective in HER2-positive breast cancer. 3) Pembrolizumab, an anti-PD-1 monoclonal antibody, used in combination with chemotherapy for PD-L1-positive triple-negative breast cancer. 4) Alpelisib, a PI3K inhibitor, for HR-positive, HER2-negative breast cancer with PIK3CA mutations. These therapies represent significant advancements in the treatment landscape for breast cancer.

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Other

DKY709 + PDR001 for Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for breast cancer include targeted therapies and immunotherapies. Targeted therapies, such as trastuzumab, work by specifically targeting and inhibiting the function of proteins involved in cancer cell growth and survival, like the HER2 receptor. Immunotherapies, such as PDR001 (an anti-PD-1 monoclonal antibody), enhance the body's immune response against cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These treatments are significant for breast cancer patients as they offer more personalized and effective options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

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

ECOG Performance Status ≤ 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

Must not have

Clinically significant cardiac disease or impaired cardiac function, including any of 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; On screening: QTcF > 450 msec (male), or > 460 msec (female); QTc not assessable; Congenital long QT syndrome; History of familial long QT syndrome or known family history of as Torsades de Pointes; Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects aren't listed here, typical reactions may include immune-related inflammation in organs due to PDR001 (an immunotherapy), infusion reactions from either drug administration, fatigue from treatment burden on the body's resources and potential blood abnormalities.

Eligibility Criteria

Inclusion Criteria

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

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

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I have NSCLC or melanoma treated with anti-PD-1/PD-L1 therapy, or I have NPC.

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I am 18 years old or older.

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

Exclusion Criteria

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.

Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.

incidence of Dose Limiting Toxicities (DLTs)

Secondary study objectives

AUC of DKY709 and PDR001

Best Overall Response (BOR)

Cmax of DKY709 and PDR001

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: DKY709 + PDR001Experimental Treatment2 Interventions

Combination therapy with DKY709 and PDR001

Group II: DKY709Experimental Treatment1 Intervention

DKY709 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PDR001

2016

Completed Phase 2

~2890

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include targeted therapies and immunotherapies. Targeted therapies, such as trastuzumab, work by specifically targeting and inhibiting the function of proteins involved in cancer cell growth and survival, like the HER2 receptor. Immunotherapies, such as PDR001 (an anti-PD-1 monoclonal antibody), enhance the body's immune response against cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. These treatments are significant for breast cancer patients as they offer more personalized and effective options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Novel systemic treatment approaches for metastatic pancreatic cancer.New drugs for breast cancer.[Trastuzumab (Herceptin) and breast cancer: mechanisms of resistance].