What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those targeting pathways like STAT3, include gastrointestinal issues (diarrhea, nausea), skin reactions (rash, erythema), and fatigue. Targeted therapies can also cause specific organ toxicities, such as hepatic adverse events. Immunotherapies, often used in combination, may lead to immune-related adverse events, including pneumonitis, colitis, and endocrinopathies.

What prior FDA approvals exist?

Several FDA-approved drugs target pathways similar to STAT3 inhibition for the treatment of solid tumors. For instance, Pembrolizumab and Nivolumab are immune checkpoint inhibitors that target the PD-1/PD-L1 pathway, enhancing the immune system's ability to fight cancer. Additionally, drugs like Ivosidenib, which targets mutant IDH1, and Olaparib, a PARP inhibitor, are approved for specific genetic mutations in solid tumors. These therapies represent a broader category of targeted treatments aimed at disrupting cancer cell growth and survival pathways, akin to the mechanism of STAT3 inhibition.

What other types of research exist?

Promising novel alternatives to DCR-STAT3 for solid tumors include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in non-small cell lung cancer (NSCLC) as per the KEYNOTE-189 study. 2) Regorafenib, which has demonstrated efficacy and safety in metastatic osteosarcoma. 3) Futibatinib, an FGFR-selective tyrosine kinase inhibitor, approved for cholangiocarcinoma with FGFR2 fusions/rearrangements. 4) Tivozanib, which has shown significant activity and a favorable safety profile in renal cell carcinoma.

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RNAi Therapeutics

DCR-STAT3 for Cancer

Phase 1

Recruiting

Research Sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented locally advanced or metastatic solid tumor malignancy or non-Hodgkin's lymphoma that is refractory to standard therapy known to provide clinical benefit for their condition or for which no standard therapy is available

Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition

Must not have

Long-term immunosuppressive therapy

Requirement for palliative radiotherapy to lesions that are defined as target lesions by RECIST version 1.1 criteria at the time of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 29 of cycle 1 (each cycle is 8 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called DCR-STAT3 in adults with hard-to-treat solid tumors. The drug aims to block a protein that helps cancer grow, potentially shrinking the tumors or stopping their growth. Another compound, OPB-31121, is also being studied for its effects on the same protein.

Who is the study for?

Adults over 18 with advanced solid tumors or non-Hodgkin's lymphoma that can't be surgically removed and haven't responded to standard treatments. Participants must not be pregnant, agree to contraception, have a life expectancy of at least 3 months, and an ECOG status of 0-2 (able to perform daily activities). They cannot join if they've had certain recent treatments or are HIV/HBV/HCV positive.

What is being tested?

The trial is testing DCR-STAT3, a new drug for people with solid tumors that no longer respond to usual treatment. It's given in increasing doses to check its safety and how the body processes it. The study will gradually enroll more patients as it confirms lower doses are safe.

What are the potential side effects?

Potential side effects of DCR-STAT3 may include typical reactions seen with cancer therapies such as fatigue, nausea, inflammation-related symptoms but specific side effects will be monitored due to the novel nature of this therapy.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced and hasn't responded to standard treatments.

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My condition worsened after treatment that usually works.

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My cancer cannot be removed by surgery due to health reasons or because the tumor can't be surgically removed.

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I can care for myself and doctors expect me to live 3 months or more.

Exclusion Criteria

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

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I am on long-term medication to suppress my immune system.

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I need targeted radiation for specific cancer lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 29 of cycle 1 (each cycle is 8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 29 of cycle 1 (each cycle is 8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 29 of cycle 1 (each cycle is 8 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events and dose limiting toxicities

Severity of adverse events

Secondary study objectives

Pharmacokinetic (AUC)

Pharmacokinetic (Urine)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCR-STAT3Experimental Treatment1 Intervention

DCR-STAT3

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

The inhibition of the STAT3 pathway, as studied in the DCR-STAT3 trial, targets a key signaling molecule involved in tumor growth and survival. STAT3 is often overactive in solid tumors, promoting cancer cell proliferation, survival, and immune evasion. By inhibiting STAT3, treatments aim to reduce tumor growth and enhance the immune system's ability to fight cancer. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth; and immunotherapy, which boosts the body's immune response against cancer cells. These treatments are crucial for managing solid tumors as they address different aspects of tumor biology and can be tailored to individual patient needs.