Non-small Cell Lung Cancer Clinical Trial
Official title:
An Open-Label Study of GV20-0251 in Patients With Advanced and/or Refractory Solid Tumor Malignancies
This is a Phase 1 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.
Status | Recruiting |
Enrollment | 268 |
Est. completion date | June 15, 2026 |
Est. primary completion date | December 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >= 18 years of age - Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy - Refractory or intolerant to standard therapy(ies) - Must have received, be not eligible or decline standard of care therapy - One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1 - For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression - ECOG performance status of 0 or 1 - Life expectancy of >=12 weeks - Disease-free of active second/secondary or prior malignancies for = 2 years - Laboratory test results within the required parameters - Women of child bearing potential (WOCBP) and men must agree to use adequate contraception - Part B ONLY must include the following tumor types: - Cohort B1: bladder urothelial carcinoma - Cohort B2: cholangiocarcinoma - Cohort B3: proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum - Cohort B4: proficient MMR (pMMR)/MSS endometrial carcinoma - Cohort B5: deficient MMR (dMMR)/MSI-H endometrial carcinoma - Cohort B6: squamous head and neck carcinoma - Cohort B7: cutaneous melanoma - Cohort B8: non-small cell lung cancer Exclusion Criteria: - Participant with acute luekemia or CLL - Participant with heart disease or unstable arrhythmia - Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy - Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy - Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection - History of major organ transplant - History of a bone marrow transplant - Symptomatic central nervous system (CNS) malignancy or metastasis - Serious nonmalignant disease - Pregnant or nursing women - Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication - Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication - Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication - Radiation for symptomatic lesions must have been completed prior to the first dose of study medication - Active substance abuse |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center | Detroit | Michigan |
United States | Virginia Cancer Specialists | Fairfax | Virginia |
United States | Florida Cancer Specialists & Research Institute, LLC | Fort Myers | Florida |
United States | Oncology Consultants, P.A. | Houston | Texas |
United States | The University of Texas M. D. Anderson Cancer Center | Houston | Texas |
United States | Community Health Network, Inc. | Indianapolis | Indiana |
United States | The Angeles Clinic and Research Institute | Los Angeles | California |
United States | Verdi Oncology Tennessee, Scri Oncology Partners | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | NYU Langone Health | New York | New York |
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
GV20 Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part A: Evaluate the safety and tolerability of escalating doses of GV20-0251 in refractory advanced malignancy participants as defined in the protocol during dose escalation | Number of participants with Dose Limiting Toxicities and Treatment Emergent Adverse/Serious Adverse Events | 12 months | |
Primary | Part A: Establish the maximum tolerated dose and/or recommended Phase 2 dose of GV20-0251 in participants with advanced solid tumor malignancies | Number of participants with Dose Limiting Toxicities and Treatment Emergent Adverse/Serious Adverse Events as well as integration of clinical laboratory, pharmacodynamic, pharmacokinetic, and preliminary efficacy endpoints | 12 months | |
Primary | Part B: Evaluate the Overall Response Rate of GV20-0251. | Overall Response Rate following GV20-0251 administration is defined as the proportion of efficacy-eligible participants who have a best response of complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A responder is defined as any participant who has a best overall response of complete response or partial response | 24 months | |
Secondary | Part A: Evaluate the Overall Response Rate (ORR) of GV20-0251. | Overall Response Rate following GV20-0251 administration is defined as the proportion of efficacy-eligible participants who have a best response of complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A responder is defined as any participant who has a best overall response of complete response or partial response | 12 months | |
Secondary | Part B: Evaluate the safety of GV20-0251 in refractory advanced malignancy patients during Part B | Number of participants with Treatment Emergent Adverse/Serious Adverse Events | 24 months | |
Secondary | Part A & Part B: Measure of area under the plasma concentration-time curve (AUC) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter AUC after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Measure the time to Cmax (Tmax) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter Tmax after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Measure of maximum plasma concentration (Cmax) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter Cmax after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Measure of Volume of distribution (Vd) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter Vd after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Measure of terminal half-life (t1/2) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter t1/2 after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Measure of trough concentration (Ctrough) of GV20-0251 when given as monotherapy. | Characterize pharmacokinetic parameter Ctrough after IV administration of GV20-0251 | 36 months | |
Secondary | Part A & Part B: Evaluate the Progression-free survival (PFS) of GV20-0251. | Progression-free survival is defined as the time from the date of study entry (start of treatment) to the first date of objectively determined progressive disease or death from any cause | 36 months | |
Secondary | Part A & Part B: Evaluate the Duration of Response (DoR) of GV20-0251. | Duration of Response is defined as the time from the date when the measurement criteria are met for complete response or partial response (whichever status is recorded first) until the date that recurrence of progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | 36 months | |
Secondary | Part A & Part B: Evaluate the Overall Survival (OS) of GV20-0251. | Overall Survival is defined as the time from the date of study entry (signing of ICF) to the date of death from any cause. | 36 months | |
Secondary | Part A & Part B: Evaluate the Disease Control Rate (DCR) of GV20-0251. | Disease Control Rate following GV20-0251 administration is defined as the proportion of efficacy-eligible participants who have a best response of complete response, partial response, or stable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |