A Study to Evaluate Safety, Tolerability and Preliminary Activity of LB101 in Participants With Advanced Solid Tumors

NCT05821777 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: LB101-1012022-003928-40
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to assess safety, tolerability, and preliminary activity of LB101 monotherapy in participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) as graded according to the NCI CTCAE v5.0

  28 days following the first dose of LB101 (Days 1 to 28 of Cycle 1)

• 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

  From start of study treatment up to 3 years

• Part 1: Number of Participants with Recommended Dose(s) for Expansion

  Recommended Dose for expansion will be determined.

  28 days following the first dose of LB101 (Days 1 to 28 of Cycle 1)

• 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)

  Up to 3 years

Secondary Outcomes (26)

• Part 1 and 2: Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator

  Up to 3 years

• Part 1 and 2: Duration of Response (DoR) According to RECIST v1.1 Evaluated by the Blinded Independent Central Review (BICR)

  Time from first objective response to first occurrence of objective tumor progression or death from any cause (up to 3 years)

• 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)

  Up to 3 years

• Part 1 and 2: Duration of Response (DoR) Assessed by Investigator

  Time from first objective response to first occurrence of objective tumor progression or death from any cause (up to 3 years)

• Part 1 and 2: Disease Control Rate (DCR) Assessed by Investigator

  Up to 3 years

Study Arms (1)

LB101

EXPERIMENTAL

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.

Drug: LB101

Interventions

LB101 DRUG

Part 1: IV infusion of LB101 Q2W (28-day cycle) and Part 2: IV infusion of LB101

LB101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Centessa Pharmaceuticals (UK) Limited: lead
• LockBody Therapeutics Ltd: collaborator

Study Sites (7)

Sarah Cannon Research Institute at HealthONE.

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute at Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology Nashville

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology - Dallas

Irving, Texas, 75039, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 of the study will be non-randomized and Part 2 design will depend on results of Part 1.

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 20, 2023
• Study Start: March 28, 2023
• Primary Completion: January 24, 2025
• Study Completion: September 9, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (6); FR (1)