Trial Title:
A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants With Advanced Solid Tumors
NCT ID:
NCT05821777
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Part 1 of the study will be non-randomized and Part 2 design will depend on results of
Part 1.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LB101
Description:
Part 1: IV infusion of LB101 Q2W (28-day cycle) and Part 2: IV infusion of LB101
Arm group label:
LB101
Summary:
The purpose of this study is to assess safety, tolerability, and preliminary activity of
LB101 monotherapy in participants with advanced solid tumors.
Detailed description:
This study consists of 2 parts: First in Human (FIH) dose escalation and dose
optimization (Part 1a and Part 1b, respectively) and dose expansion (Part 2). Part 1 will
evaluate LB101 monotherapy in participants with selected, advanced solid tumors and
determine the Recommended Dose(s) for Expansion (RDE(s)) for Part 2. The design of Part 2
depends on the results of Part 1 and will further evaluate the safety, efficacy,
tolerability, pharmacokinetics, and immune response of LB101.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female participants >= 18 years old
- Signed informed consent form (ICF)
- For Part 1: Participants who i). have a histologically confirmed solid tumor that is
listed below and is advanced, unresectable, and/or metastatic and ii). have no
standard therapy, are not candidates for available standard therapy, or have failed
systemic therapy due to lack of response, progression, or intolerance:
- Non-small cell lung cancer (NSCLC), which is known to be PD L1 positive (combined
positive score [CPS] ≥ 1 or tumor proportion score [TPS] ≥ 1%) after having received
pembrolizumab or other analog immune checkpoint inhibitor at any stage of their
prior therapy I. Subjects with PD-L1 positive NSCLC with known genomic alterations
for which targeted therapy is approved are not required to have been treated with
pembrolizumab, etc. but must have received such approved targeted therapy. Genomic
alternations include, but are not limited to, epidermal growth factor receptor
[EGFR] and anaplastic lymphoma kinase [ALK]
- Head and neck squamous cell carcinoma or cervical cancer, which is known to be
PD-L1-positive, after having received immune checkpoint inhibitor at any stage of
their prior therapy
- Cutaneous squamous cell cancer after having received immune checkpoint inhibitor at
any stage of their prior therapy
- Colorectal cancer with low level microsatellite instability (MSI-low) and/or
microsatellite stable(MSS)
- Ovarian cancer which is platinum resistant or platinum refractory, with platinum
free interval of less than 6 months, and without rapidly progressing disease in the
investigator's judgment
- Gastric cancer which is known to be PD-L1 positive after having received
pembrolizumab or other analog immune checkpoint inhibitor at any stage of their
prior therapy
- Participants have measurable disease according to RECIST v1.1
- Available archived tumor tissue sample (Part 1a)
- In Part 1a backfill cohort(s), Part 1b, and Part 2, subjects must agree to undergo
baseline tumor biopsy
- Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1
- Participants have adequate hematological function
- Participants have adequate hepatic and renal function
- Participants have a baseline QT interval as corrected by Fridericia's formula <= 480
milliseconds
- Participants with life expectancy >= 12 weeks
- Participants have a body weight >= 40 kilograms
- For female participants of childbearing potential:
- Negative urine or serum pregnancy test
- Willing to use 2 highly effective methods of contraception
- For male participants who can father a child:
- Willing to use 2 highly effective methods of contraception
Exclusion Criteria:
- Participants with unknown PD-L1 status for the following tumor types: NSCLC, head
and neck squamous cell carcinoma, or cervical cancer
a.In Part 1a backfill cohort(s), any subject with unknown PD-L1 status
- Participants with known negative PD-L1 status
- Participants with NSCLC, head and neck squamous cell carcinoma, cervical cancer,
cutaneous squamous cell cancer, or gastric cancer that have NOT received checkpoint
inhibitor for advanced/metastatic disease, unless such therapy is not approved for
treating a subject's specific condition
- Participants who receive adjuvant systemic therapy and progressed with advanced
disease within 6 months of completing treatment
- Participants who have had previous exposure to CD47 or SIRPα targeting anticancer
therapy
- Participants participating in another interventional clinical study
- Participants who have ongoing side effects to any prior therapy or procedure, which
have not recovered to NCI CTCAE Grade <= 1
- Participants who have received immunosuppressive drugs within 7 days prior to the
start of LB101 or systemic glucocorticoids equivalent
- Participants who have received a live attenuated vaccine within 4 weeks prior to the
start of LB101. For any subject receiving an approved severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) vaccine, the investigator will be advised to
follow the vaccine label and/or local guidance
- Participants with primary brain tumors and evidence of new or progressing
cerebrospinal or leptomeningeal metastases
- Participants who have a history of Grade ≥ 3 allergic reactions to monoclonal
antibody therapy as well as known or suspected allergy or intolerance to any
components of LB101
- Participants with active or suspected systemic inflammatory autoimmune diseases or
with a history of documented autoimmune disease over the past 2 years
- Participants who have ongoing or active infection requiring IV anti-infective
medications
- Participants with a known history of:
- Seropositivity for human immunodeficiency virus (HIV)
- Positive serology for hepatitis B, known history/positive serology for hepatitis C
virus (HCV)
- Allogenic organ transplantation and/or hematopoietic stem cell transplantation
- Participants who have had a history of life-threatening treatment-related AEs with
prior immunotherapy or who have not recovered from prior cancer therapy-induced AEs
- Participants with clinically significant ascites
- Participants with moderate bilateral pleural effusion or massive bilateral pleural
effusion or respiratory dysfunction requiring drainage
- Participants with uncontrolled cardiovascular disease
- Participants with any other acute or chronic diseases, psychiatric disorders, or
abnormal laboratory test values that, at the discretion of the investigators are
deemed ineligible to participate
- Participants with a history of other advanced solid tumor malignancies except:
- Cured malignant tumors for > 2 years prior to enrollment and no known active disease
- Tumors with negligible risk of metastases or death
- Pregnant or lactating female participants
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute at HealthONE.
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Judy Wang, Dr.
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chrisann Kyi
Facility:
Name:
Sarah Cannon Research Institute at Tennessee Oncology Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Melissa Johnson, Dr.
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology - Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Contact:
Last name:
Stephane Champiat, MD
Start date:
March 28, 2023
Completion date:
January 5, 2027
Lead sponsor:
Agency:
Centessa Pharmaceuticals (UK) Limited
Agency class:
Industry
Collaborator:
Agency:
LockBody Therapeutics Ltd
Agency class:
Industry
Source:
Centessa Pharmaceuticals plc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05821777
