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

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ClinicalTrials.gov Identifier: NCT05669430
Recruitment Status : Recruiting
First Posted : December 30, 2022
Last Update Posted : February 5, 2024
Sponsor:
Information provided by (Responsible Party):
GV20 Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Refractory Cancer Bladder Urothelial Carcinoma Cholangiocarcinoma Adenocarcinoma of the Colon Endometrial Carcinoma Head and Neck Carcinoma Cutaneous Melanoma Non-small Cell Lung Cancer Adenocarcinoma of the Rectum Drug: GV20-0251 Phase 1

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of GV20-0251 in Patients With Advanced and/or Refractory Solid Tumor Malignancies
Actual Study Start Date : March 23, 2023
Estimated Primary Completion Date : December 15, 2025
Estimated Study Completion Date : June 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A - Dose Escalation
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.
 Drug: GV20-0251
Increasing doses of GV20-0251 given intravenously as monotherapy.
Experimental: Part B - Multiple Expansion Cohorts
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 participants with selected malignancies.
 Drug: GV20-0251
GV20-0251 RP2D given intravenously as monotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]
    Number of participants with Dose Limiting Toxicities and Treatment Emergent Adverse/Serious Adverse Events

  2. Part A: Establish the maximum tolerated dose and/or recommended Phase 2 dose of GV20-0251 in participants with advanced solid tumor malignancies [ Time Frame: 12 months ]
    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

  3. Part B: Evaluate the Overall Response Rate of GV20-0251. [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Part A: Evaluate the Overall Response Rate (ORR) of GV20-0251. [ Time Frame: 12 months ]
    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

  2. Part B: Evaluate the safety of GV20-0251 in refractory advanced malignancy patients during Part B [ Time Frame: 24 months ]
    Number of participants with Treatment Emergent Adverse/Serious Adverse Events

  3. Part A & Part B: Measure of area under the plasma concentration-time curve (AUC) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter AUC after IV administration of GV20-0251

  4. Part A & Part B: Measure the time to Cmax (Tmax) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter Tmax after IV administration of GV20-0251

  5. Part A & Part B: Measure of maximum plasma concentration (Cmax) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter Cmax after IV administration of GV20-0251

  6. Part A & Part B: Measure of Volume of distribution (Vd) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter Vd after IV administration of GV20-0251

  7. Part A & Part B: Measure of terminal half-life (t1/2) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter t1/2 after IV administration of GV20-0251

  8. Part A & Part B: Measure of trough concentration (Ctrough) of GV20-0251 when given as monotherapy. [ Time Frame: 36 months ]
    Characterize pharmacokinetic parameter Ctrough after IV administration of GV20-0251

  9. Part A & Part B: Evaluate the Progression-free survival (PFS) of GV20-0251. [ Time Frame: 36 months ]
    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

  10. Part A & Part B: Evaluate the Duration of Response (DoR) of GV20-0251. [ Time Frame: 36 months ]
    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).

  11. Part A & Part B: Evaluate the Overall Survival (OS) of GV20-0251. [ Time Frame: 36 months ]
    Overall Survival is defined as the time from the date of study entry (signing of ICF) to the date of death from any cause.

  12. Part A & Part B: Evaluate the Disease Control Rate (DCR) of GV20-0251. [ Time Frame: 36 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05669430


Contacts
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Contact: GV20 Therapeutics 617-256-2846 clinicaltrials@gv20tx.com

Locations
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United States, California
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Kristopher Wentzel, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Patricia LoRusso, DO         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Janice Mehnert, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Shivaani Kummar, MD         
United States, Texas
Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77030
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Jose Peguero, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: GV20 Therapeutics       clinicaltrials@gv20tx.com   
Principal Investigator: Alexander Spira, MD         
Sponsors and Collaborators
GV20 Therapeutics
More Information
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Responsible Party: GV20 Therapeutics
ClinicalTrials.gov Identifier: NCT05669430    
Other Study ID Numbers: GV20-0251-100
First Posted: December 30, 2022    Key Record Dates
Last Update Posted: February 5, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Cholangiocarcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases