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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically confirmed, advanced/metastatic non-small cell lung cancer (NSCLC)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Has unstable central nervous system metastasis
Has persistent toxicities from previous systemic anti-cancer treatments of Grade >1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
"This trial will test a new drug called PHN-010 in patients with advanced solid tumors to see how safe and effective it is, as well as how the body processes the drug."
Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung, endometrial, ovarian, cervical, and colon cancers. Participants must have had at least one prior therapy and no available standard treatment options or be intolerant to them. They should have a performance status of 0 or 1 (able to carry out daily activities), measurable disease, adequate organ function, and a tumor tissue sample.
What is being tested?
PHN-010 is being tested in this study. It's an antibody-drug conjugate aimed at treating various advanced solid tumors. The trial will assess its safety, how well it's tolerated by patients' bodies, its effectiveness against cancer cells (anti-tumor activity), immune response (immunogenicity), distribution within the body (pharmacokinetics), and effect on the body's biological processes (pharmacodynamics).
What are the potential side effects?
While specific side effects of PHN-010 are not listed here as it’s a first-in-human study assessing this new drug; generally such drugs can cause reactions where they're injected into the body, fatigue, nausea or vomiting due to their impact on rapidly dividing cells like those found in tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced and has spread to other parts.
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I am fully active or can carry out light work.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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My cancer is a specific type of advanced endometrial cancer.
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My cancer can be measured by tests.
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My colorectal cancer has spread and is confirmed by lab tests.
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My cervical cancer is advanced and confirmed by lab tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brain and is not stable.
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I have lasting side effects from cancer treatment that are mild or worse.
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I haven't taken cancer drugs within the last 21 days or five half-lives, whichever is shorter.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I have not had major surgery in the last 28 days or still have side effects from it.
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I have not fully recovered from recent radiation therapy side effects.
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I have been treated with a drug that targets cancer cells and carries a specific toxin.
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I do not have any serious infections, including HBV, HCV, or HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1a and Phase 1bExperimental Treatment1 Intervention
PHN-010 is administered intravenously.
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Who is running the clinical trial?
Pheon TherapeuticsLead Sponsor
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