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LB101 for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Centessa Pharmaceuticals (UK) Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with available archived tumor tissue sample (Part 1a)
Participants with ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests a new cancer treatment to see if it's safe, tolerable, and effective against advanced tumors.
Who is the study for?
Adults (18+) with advanced solid tumors, including specific types of lung, head and neck, cervical, ovarian cancers. Must have tried checkpoint inhibitors previously or have no standard treatment options left. Participants need to be in relatively good health with a life expectancy of at least 12 weeks and weigh over 40 kg. They must agree to use two effective contraception methods if applicable and provide tissue samples.Check my eligibility
What is being tested?
The trial is testing LB101 as a solo treatment for various advanced solid tumors to see how safe it is and if it works. It involves people who've already had certain treatments like immune checkpoint inhibitors or those without other treatment choices.See study design
What are the potential side effects?
Specific side effects are not listed but generally could include typical reactions to cancer therapies such as fatigue, nausea, allergic reactions, potential organ inflammation due to immune response, and possibly unique side effects related to LB101's mechanism of action.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a stored sample of my tumor tissue.
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I am fully active or can carry out light work.
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My cancer is advanced, cannot be surgically removed, and may have spread.
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I weigh at least 40 kilograms.
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I am a woman who can have children, not pregnant, and willing to use birth control.
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I am a man and willing to use birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as defined as events that started or worsened after first dose of study intervention until 30 days after last dose
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) as graded according to the NCI CTCAE v5.0
Part 1: Number of Participants with Recommended Dose(s) for Expansion
+1 moreSecondary outcome measures
Part 1 and 2: Disease Control Rate (DCR) Assessed by Investigator
Part 1 and 2: Duration of Response (DoR) According to RECIST v1.1 Evaluated by the Blinded Independent Central Review (BICR)
Part 1 and 2: Duration of Response (DoR) Assessed by Investigator
+23 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LB101Experimental Treatment1 Intervention
Part 1
Part 1a participants will receive LB101 once every 2 weeks (Q2W) (28-day cycle), with a preliminary plan for 6 sequential dose levels. Part 1b will be a dose optimization and will include >1 dose levels and/or dose schedules that have been deemed safe and tolerable in Part 1a.
Part 2
Dose regimen(s) for participants in Part 2 will be based on the results of Part 1.
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Who is running the clinical trial?
Centessa Pharmaceuticals (UK) LimitedLead Sponsor
LockBody Therapeutics LtdIndustry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received immunotherapy for my cancer.My advanced disease worsened within 6 months after finishing my initial cancer treatment.I am currently on IV medication for an infection.My blood counts are within a healthy range.I do not have severe fluid buildup, breathing problems, heart issues, or other serious health conditions.I haven't taken immunosuppressive drugs in the last 7 days.I have a stored sample of my tumor tissue.I am fully active or can carry out light work.I have not received a live vaccine in the last 4 weeks.My brain tumor is growing or spreading.I have had severe allergic reactions to antibody treatments or ingredients in this study.My PD-L1 status is unknown for my cancer type.I have had another type of advanced solid tumor cancer.My cancer is advanced, cannot be surgically removed, and may have spread.I have been treated with CD47 or SIRPα targeting cancer therapy before.I weigh at least 40 kilograms.I am a woman who can have children, not pregnant, and willing to use birth control.I am a man and willing to use birth control.My cancer is PD-L1 negative.My liver and kidneys are working well.My side effects from previous treatments are mild or gone.I have a specific type of cancer and a detailed treatment history.I am 18 years old or older.I have a history of HIV, hepatitis B or C, or organ transplantation.
Research Study Groups:
This trial has the following groups:- Group 1: LB101
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor still open?
"According to clinicaltrials.gov, this trial is still actively searching for volunteers. The research was initially posted on March 28th 2023 and has undergone modifications as recently as April 6th of the same year."
Answered by AI
What is the participant capacity for this trial?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is open for enrollment and was posted online on March 28th 2023 with the most recent update coming April 6th of that same year. Currently, 180 patients are being sought from one site."
Answered by AI
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