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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more
Secondary 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 more

Trial 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.

Find a Location

Who is running the clinical trial?

Centessa Pharmaceuticals (UK) LimitedLead Sponsor
LockBody Therapeutics LtdIndustry Sponsor

Media Library

LB101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05821777 — Phase 1 & 2
Solid Tumors Research Study Groups: LB101
Solid Tumors Clinical Trial 2023: LB101 Highlights & Side Effects. Trial Name: NCT05821777 — Phase 1 & 2
LB101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821777 — Phase 1 & 2

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
~127 spots leftby Jan 2027