What side effects are associated with this type of intervention?

Common side effects of targeted therapies for solid tumors include fatigue, diarrhea, liver toxicity, skin rashes, and hypertension. Immunotherapies, such as immune checkpoint inhibitors, can lead to immune-related adverse events like colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. Both treatment types may also cause nausea, decreased appetite, and infusion reactions.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of solid tumors. Notable examples include immune checkpoint inhibitors like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Additionally, targeted therapies such as vemurafenib and dabrafenib, which inhibit the BRAF V600E mutation, have been approved for melanoma. These treatments aim to either inhibit specific molecular pathways involved in tumor growth or enhance the body's immune response to fight cancer.

What other types of research exist?

Promising novel alternatives to MDK-703 for solid tumor patients include: <ol> <li>Pembrolizumab (an immune checkpoint inhibitor) combined with chemotherapy, as seen in the KEYNOTE-189 study for non-small cell lung cancer.</li> <li></li> </ol> Regorafenib, which has shown efficacy in metastatic osteosarcoma. 3. Nivolumab plus ipilimumab, which has demonstrated effectiveness in malignant pleural mesothelioma. 4. Atezolizumab plus bevacizumab, which has been effective in metastatic renal cell carcinoma. 5. Enfortumab vedotin, a novel antibody-drug conjugate, for urothelial carcinoma. These therapies represent significant advancements in the treatment of various solid tumors and are likely to be relevant options in 2024.

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Checkpoint Inhibitor

MDK-703 for Advanced Cancer (ORCHID-1 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Medikine, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called MDK-703 to see if it can help treat adults with advanced or spreading solid tumors. Researchers are checking if the drug is safe, effective, and how it behaves in the body.

Who is the study for?

Adults with advanced or metastatic solid tumors can join this trial. They must have stable vital organ functions, resolved any previous cancer treatment side effects, and agree to use birth control. People with recent serious health events like strokes, uncontrolled diabetes, major surgery, or certain heart conditions cannot participate.

What is being tested?

MDK-703 is being tested both alone and alongside other cancer treatments in adults with advanced solid tumors. This study has two parts: first finding the right dose of MDK-703 (dose escalation), then seeing how well it works at that dose (dose expansion).

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to immune therapies such as inflammation in various organs, allergic reactions to components of MDK-703 or checkpoint inhibitors used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 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

Adverse events (AE)

Dose Limiting Toxicities (DLT)

Maximum tolerated dose (MTD)

+2 more

Secondary study objectives

Blood concentration of MDK-703

Disease Control Rate (DCR)

Duration of Response (DOR)

+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: MDK-703 in combination with a checkpoint inhibitorExperimental Treatment2 Interventions

MDK-703 will be administered in sequential ascending doses in combination with a checkpoint inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent.

Group II: MDK-703 MonotherapyExperimental Treatment1 Intervention

MDK-703 will be administered in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent.

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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 solid tumors, such as targeted therapies and immunotherapies, work by either inhibiting specific molecular pathways essential for tumor growth or by enhancing the body's immune response against cancer cells. Targeted therapies block proteins or enzymes involved in cell signaling that promote cancer cell proliferation, while immunotherapies boost the immune system's ability to attack tumors by blocking inhibitory checkpoints or stimulating immune cells. These approaches are important for solid tumor patients as they provide more precise and potentially less toxic treatment options compared to traditional chemotherapy.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Propelling Immunotherapy Combinations Into the Clinic.