Study Summary
This trial tests a new cancer treatment to see if it's safe, tolerable, and effective against advanced tumors.
Eligible Conditions
- Advanced Solid Tumors
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
4 Primary · 26 Secondary · Reporting Duration: Up to 3 years
Day 28
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
Day 1
Part 2: Area Under the Concentration-time Curve at 14 days Post Drug Administration (AUC14days) of LB101
Day 1
Part 2: Apparent Total Body Clearance (CL/F) of LB101
Part 2: Apparent Volume of Distribution (Vd/F) of LB101
Part 2: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-last) of LB101
Part 2: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of LB101
Part 2: Elimination Half-life (t1/2) of LB101
Part 2: Elimination Rate Constant (Kel) of LB101
Part 2: Maximum (peak) Concentration (Cmax) of LB101
Part 2: Predose Trough Concentrations (CTrough) of LB101
Part 2: Time to Maximum Observed Concentration (Tmax) of LB101
Day 1
Part 1: Area Under the Concentration-time Curve at 14 days Post Drug Administration (AUC14days) of LB101
Day 1
Part 1: Apparent Total Body Clearance (CL/F) of LB101
Part 1: Apparent Volume of Distribution (Vd/F) of LB101
Part 1: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-last) of LB101
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of LB101
Part 1: Elimination Half-life (t1/2) of LB101
Part 1: Elimination Rate Constant (Kel) of LB101
Part 1: Maximum (peak) Concentration (Cmax) of LB101
Part 1: Predose Trough Concentrations (CTrough) of LB101
Part 1: Time to Maximum Observed Concentration (Tmax) of LB101
Year 3
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
Year 3
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
Up to 3 years
Part 1 and 2: Disease Control Rate (DCR) Assessed by Investigator
Part 1 and 2: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to LB101
Part 1 and 2: Proportion of Participants with Disease Control Rate (DCR) According to RECIST v1.1 Evaluated by the Blinded Independent Central Review (BICR)
Part 1 and 2: Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Part 2: Proportion of Participants with Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Evaluated by the Blinded Independent Central Review (BICR)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
LB101
1 of 1
Experimental Treatment
180 Total Participants · 1 Treatment Group
Primary Treatment: LB101 · No Placebo Group · Phase 1 & 2
LB101
Drug
Experimental Group · 1 Intervention: LB101 · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Who is running the clinical trial?
Centessa Pharmaceuticals (UK) LimitedLead Sponsor
LockBody Therapeutics LtdIndustry Sponsor
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are male and capable of conceiving a child.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer