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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phase 1a: Dose escalation / LB-LR1109 monotherapy | Experimental |
| |
| Phase 1b: Dose escalation / LB-LR1109 in combination with Atezolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1a: LB-LR1109 | Drug | intravenous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Number of participants with dose-limiting toxicities (DLTs) | through study completion, an average of 1year |
| Phase 1a: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 as monotherapy / Phase 1b: Incidence of Treatment-Emergent Adverse Events of LB-LR1109 as combination therapy with atezolizumab | Incidence, severity (assessed by NCI CTCAE v5.0), and causality of AEs | through study completion, an average of 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a / 1b: Preliminary efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | ORR(overall response rate) assessed by RECIST v1.1 (%) | through study completion, an average of 1year |
| Phase 1a / 1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab |
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Key Inclusion Criteria:
Age ≥18 years old at the time of signing the ICF.
(Phase 1a only) Participants must have 1 of the following histologically confirmed advanced or metastatic solid tumors with measurable or non-measurable disease as determined by RECIST v1.1,
- NSCLC, HNSCC, RCC, urothelial carcinoma, or malignant melanoma.
(Phase 1a only) Participants who have metastatic disease which has progressed during or after approved standard therapies or are intolerant to approved therapies, or for which the participant refuses or is ineligible for standard therapy.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Life expectancy ≥12 weeks.
Participants with adequate organ function
No potential for childbearing or agree to use adequate contraception
Ability to understand the study purpose and procedures and have the willingness to sign a written informed consent document.
(Phase 1b only ) Must have histologically confirmed advanced or metastatic NSCLC without actionable genomic alteration that have approved therapies in the location where the participant's live and with measurable disease as determined by RECIST v1.1
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEXT Oncology | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Phase 1b: LB-LR1109 and Atezolizumab |
| Drug |
intravenous administration |
|
PFS(Progression free survival) |
| through study completion, an average of 1year |
| Phase 1a/1b: Antitumor efficacy of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | OS (Overall survival) (months) | through study completion, an average of 1year |
| Phase 1a / 1b: Pharmacokinetic profile of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | Cmax (Maximum serum drug concentration) | through study completion, an average of 1year |
| Phase 1a / 1b: Characterize PK of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | Area under the concentration-time curve (AUC) 0-last | through study completion, an average of 1year |
| Phase 1a / 1b: Immunogenicity of LB-LR1109 as monotherapy and as combination therapy with atezolizumab | Number and percentage of participants with ADAs | through study completion, an average of 1year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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