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MDK-703 for Advanced Cancer (ORCHID-1 Trial)
ORCHID-1 Trial Summary
This trial tests a new cancer therapy and looks at its effects in adults with advanced or metastatic tumors.
ORCHID-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ORCHID-1 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: MDK-703 Monotherapy
- Group 2: MDK-703 in combination with a checkpoint inhibitor
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are minors permitted to partake in this experiment?
"According to the parameters of this clinical trial, individuals aged 18-99 are eligible for enrollment. For minors and seniors respectively, there are 297 trials and 2175 available options."
How many locations are hosting this clinical investigation?
"This clinical study is taking place at 5 centres throughout the USA, including Huntersville, Austin and Houston. Prospective participants are encouraged to select a site closest to them in order to reduce their need for travel."
Is this scientific experiment still open for enrollment?
"Affirmative. The clinical trial is actively recruiting, as indicated by its listing on clinicaltrials.gov which was initially published on February 8th 2023 and recently updated the following day. Currently, 5 medical centres need to recruit a total of 150 participants for this study."
To what extent is this experiment being implemented among trial participants?
"To ensure the efficacy of this trial, Medikine Inc. requires 150 participants that satisfy its inclusion criteria. To achieve this goal they will be reaching out to patients through two sites: Carolina BioOncology Institute in Huntersville, NC and NEXT Oncology Austin located in Texas' capital city."
What is the primary purpose of this research?
"As per the clinical trial's financer, Medikine Inc., the primary variable to be monitored and measured over a 24-month period is Maximum Tolerated Dosage (MTD). Furthermore, researchers are also keeping track of secondary outcomes such as Duration of Response (DOR), Time to Response (TTR) and Disease Control Rate (DCR). All these metrics are based on imaging assessment by RECIST version 1.1."
Is it possible to become a participant in this research trial?
"This medical trial is searching for 150 human subjects suffering from advanced or metastatic solid tumours who are aged between 18 and 99. To qualify, these patients must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and an Eastern Cooperative Oncology Group performance status of 0 or 1, as well as satisfactory cardiovascular, hematological, liver, and renal function. Furthermore, female participants with childbearing potential and male individuals not surgically sterile must agree to use medically-accepted contraceptive measures throughout the study period; males should also abstain from banking sperm during this time frame"
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