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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
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
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 moreSecondary study objectives
Blood concentration of MDK-703
Disease Control Rate (DCR)
Duration of Response (DOR)
+5 moreTrial 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.
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.
Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Propelling Immunotherapy Combinations Into the Clinic.
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Who is running the clinical trial?
Medikine, Inc.Lead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
Joseph Leveque, MDStudy DirectorChief Medical Officer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart problems or significant heart disease.I have had a transplant of bone marrow or an organ.I do not have any serious health issues that would stop me from following the study's treatment plan.I am allergic or cannot tolerate the medication MDK-703 or any checkpoint inhibitors.I have not had radiotherapy in the last 14 days.I have not had major surgery in the last 30 days nor do I expect to during the study.I do not have HIV, active hepatitis C, or uncontrolled hepatitis B.I haven't had cancer treatment or experimental drugs in the last 2 weeks or 4 weeks for immunotherapy.My cancer has spread to my brain or its coverings.I don't have severe side effects from previous treatments, except for hair loss, skin changes, or mild nerve pain.I do not have uncontrolled diabetes or immune-related hormone issues.I have an autoimmune disease that needed treatment in the last 3 months.I have not had a stroke or similar brain event in the last 6 months.I have had serious lung problems or needed oxygen in the last 6 months.I have been cancer-free for more than 2 years or had a minor cancer removed.I was diagnosed with a lung clot less than 3 months ago.I agree to use birth control during the study.I have not had serious bleeding in the last 2 weeks.Any side effects from my previous cancer treatments have resolved.My heart, blood, liver, and kidneys are functioning well.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: MDK-703 Monotherapy
- Group 2: MDK-703 in combination with a checkpoint inhibitor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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