Study to Evaluate LB-LR1109, Administered Alone for the Treatment of Solid Tumor and in Combination With Atezolizumab for the Treatment of NSCLC

Conditions

• Head and Neck Squamous Cell Carcinoma(HNSCC)
• Malignant Melanoma
• Non-small Cell Lung Cancer(NSCLC)
• Renal Cell Carcinoma(RCC)
• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Phase 1a: LB-LR1109 — DRUG
  intravenous administration
• Phase 1b: LB-LR1109 and Atezolizumab — DRUG
  intravenous administration

Study Details

This is a Phase 1a/1b, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose (RP2D) and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109 as monotherapy in participants with advanced and/or metastatic non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), renal cell carcinoma (RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options, and as combination therapy with atezolizumab in participants with advanced and/or metastatic NSCLC.

Key Dates

Start date

Jun 5, 2024

Status verified

Nov 2025

Primary completion

Nov 30, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

76 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: phase 1a: Dose escalation / LB-LR1109 monotherapy
• Experimental: Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab

Primary Outcome Measure

Phase 1a: MTD and/or RP2D of LB-LR1109 as monotherapy in participants with advanced or metastatic solid tumors / Phase 1b: MTD and/or RP2D of LB-LR1109 as combination therapy with atezolizumab in participants with advanced or metastatic NSCLC [ Time Frame: through study completion, an average of 1year ]

Locations (1)

Find similar trials in Fairfax, VA

Related Studies

• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
  PHASE2 · Recruiting · Seagen, a wholly owned subsidiary of Pfizer · Gilbert, Arizona
• Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
  PHASE1 · Recruiting · SystImmune Inc. · Birmingham, Alabama
• A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
  PHASE2 · Recruiting · Jazz Pharmaceuticals · Prescott, Arizona