A Study of GV20-0251 in Patients With Solid Tumor Malignancies

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669430
• Other study ID #: GV20-0251-100
• Status: Recruiting
• Phase: Phase 1
• Start date: March 23, 2023
• Est. completion date: June 15, 2026

Study information

• Verified date: February 2024
• Source: GV20 Therapeutics
• Contact: GV20 Therapeutics
• Phone: 617-256-2846
• Email: clinicaltrials[@]gv20tx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a Phase 1 non-randomized, open label, multi-center study to be conducted in two parts (Parts A and B). Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities and to establish the maximum tolerated dose and/or the recommended Phase 2 dose of GV20-0251. Part B consists of multiple expansion cohorts in which eligible participants will be treated at the recommended Phase 2 dose of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in patients with selected malignancies. The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit, Safety Follow-Up Period and a Survival Follow-Up Period.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Bladder Urothelial Carcinoma
• Carcinoma
• Cholangiocarcinoma
• Cutaneous Melanoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Head and Neck Carcinoma
• Non-small Cell Lung Cancer
• Refractory Cancer
• Solid Tumor, Adult

Intervention

Drug:
• GV20-0251
Increasing doses of GV20-0251 given intravenously as monotherapy.
• GV20-0251
GV20-0251 RP2D given intravenously as monotherapy.

Locations

Country	Name	City	State
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Oncology Consultants, P.A.	Houston	Texas
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Health	New York	New York
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
GV20 Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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