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Monoclonal Antibodies

FL115 for Cancer

Phase 1
Recruiting
Research Sponsored by Suzhou Forlong Biotechnology Co.,Ltd,
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function as evidenced by specific requirements
Progressed on or are intolerant to all standard therapies including checkpoint inhibitors (such as PD-1, PDL-1, CTLA-4) as a single agent or in combination with oncolytic vaccine, antibody, or chemotherapeutic agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to 30 days after last dose.
Awards & highlights

Summary

This trial will test a new cancer drug to evaluate its safety, effects on the body, and ability to fight tumors in advanced cancer patients.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments, including checkpoint inhibitors. Participants must have a measurable tumor or disease, be in relatively good health (ECOG status 0 or 1), and expect to live at least another six months. They need proper liver, kidney, and blood function and agree to use effective contraception.
What is being tested?
The study tests FL115's safety and how well it works against solid tumors that are tough to treat. It's the first time humans will try this drug (Phase I). Patients get increasing doses of FL115 while researchers watch for any reactions, check how their bodies handle the drug (pharmacokinetics), see if there are signs of improvement in their cancer, and note any side effects.
What are the potential side effects?
Since this is a first-in-human study of FL115, specific side effects aren't known yet. Generally, such trials look out for new drugs causing unexpected reactions like allergies, fatigue, nausea or affecting organ functions which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function meets the required standards.
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My condition worsened or I couldn't tolerate all standard treatments, including immunotherapies.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver is functioning well.
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My blood counts meet the required levels.
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I can stay in the hospital overnight after my first and other treatment visits.
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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to 30 days after last dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to 30 days after last dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the safety and tolerability of FL115 in approximately 26 patients with unresectable locally advanced or metastatic solid tumors

Trial Design

1Treatment groups
Experimental Treatment
Group I: A Single ArmExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Suzhou Forlong Biotechnology Co.,Ltd,Lead Sponsor
~7 spots leftby May 2025
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