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Solid Tumor, AdultPhase 1/2NCT05669430

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

A Phase 1/2 study testing GV20-0251 and GV20-0251 and Pembrolizumab [KEYTRUDA®] in people with Solid Tumor, Adult and Refractory Cancer, run by GV20 Therapeutics at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 1/2A 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GV20-0251 and GV20-0251 and Pembrolizumab [KEYTRUDA®]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
13 sitesUnited States
Study dates
23 Mar 2023to 5 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants ≥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
  • Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
  • For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
Show all 41Show fewer
  • ECOG performance status of 0 or 1
  • Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D
  • Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible
  • 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
  • Parts B, C and D may include the following tumor types:
  • Endometrial carcinoma
  • Squamous head and neck carcinoma
  • Cutaneous melanoma
  • Non-small cell lung cancer
  • Proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum (Parts C and D only)
  • Parts A, B, C and D Exclusion Criteria:
  • Participant with acute leukemia or CLL (Parts A and B only)
  • 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
  • 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
  • Participants with liver metastases unless approved by the Sponsor
  • Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1
  • Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)
  • Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and/or any of its excipients (Parts C and D only)
  • Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease (Parts C and D only)
  • Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)
  • Active substance abuse

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

GV20 Therapeutics contact

617-256-2846

clinicaltrials@gv20tx.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Justin Gainor, MD

    Recruiting

  • HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Jason Henry, MD

    Not yet recruiting

  • Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

    Detroit, Michigan, 48201

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    M. Najeeb Al Hallak, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Alexander Spira, MD

    Recruiting

  • Florida Cancer Specialists & Research Institute, LLC

    Fort Myers, Florida, 33916

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Judy Wang, MD

    Not yet recruiting

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Jose Peguero, MD

    Recruiting

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Aung Naing, MD

    Recruiting

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Bert O'Neil, MD

    Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Kristopher Wentzel, MD

    Recruiting

  • Verdi Oncology Tennessee, Scri Oncology Partners

    Nashville, Tennessee, 37203

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Meredith Pelster, MD

    Not yet recruiting

  • Yale University

    New Haven, Connecticut, 06511

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Patricia LoRusso, DO

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Janice Mehnert, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    GV20 Therapeutics, clinicaltrials@gv20tx.com

    Shivaani Kummar, MD

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies

This is a Phase 1/2A 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.

Read the detailed description

This is a Phase 1/2A non-randomized, open label, multi-center study to be conducted in four parts (Parts A, B, C and D).

In Part A, a 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).

In Part B, the Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.

In Part C, the Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with Pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination.

In Part D, BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with Pembrolizumab at the preliminary RP2D across multiple expansion cohorts involving eligible participants.

Being tested
GV20-0251, GV20-0251 and Pembrolizumab [KEYTRUDA®]
Keywords
GV20-0251
Medical subject headings
Neoplasms, Endometrial Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GV20-0251Biological

    Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.

  • GV20-0251Biological

    GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.

  • GV20-0251 and Pembrolizumab [KEYTRUDA®]Biological

    Also called MK-3475

    GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

  • GV20-0251 and Pembrolizumab [KEYTRUDA®]Biological

    Also called MK-3475

    GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

Study groups in NCT05669430
Study groupRoleWhat they receive
Part A - Dose Escalation in up to 7 dose levelsExperimentalA 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).
Receives: Biological: GV20-0251
Part B - Multiple Expansion Cohorts in up to 4 tumor indicationsExperimentalThe Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D in up to 4 expansion cohorts involving eligible participants.
Receives: Biological: GV20-0251
Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levelsExperimentalThe Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination in selected tumor indications.
Receives: Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]
Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indicationsExperimentalThe BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with pembrolizumab at the preliminary RP2D in up to 5 expansion cohorts involving eligible participants.
Receives: Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)

    ORR

    Measured: 12 months

  2. Percentage of Participants With Adverse Events (Parts A and C)

    Measured: 12 months

Secondary outcomes (12)

  1. Overall Survival (Parts B and D)

    OS

    Measured: 24 months

  2. Additional safety and tolerability

    TEAEs per NCI CTCAE version 5.0

    Measured: 24 months

  3. Cmax of GV20-0251

    Maximum concentration

    Measured: 12 months

  4. Tmax of GV20-0251

    Time to peak drug concentration

    Measured: 12 months

  5. T1/2

    Terminal half-life of GV20-0251

    Measured: 12 months

  6. AUC

    Area under the curve

    Measured: 12 months

  7. ADAs

    Specification and quantification of anti-drug antibodies

    Measured: 12 months

  8. nADAs

    Neutralizing anti-drug antibodies

    Measured: 12 months

  9. DCR

    Disease Control Rate is the percentage of participants with stable disease, complete response or partial response among all response evaluable participants

    Measured: 24 months

  10. DoR

    Duration of Response is the time from first CR/PR to the date of PD or death.

    Measured: 24 months

  11. PFS

    Progression Free Survival is the duration from the first dose to PD/death

    Measured: 24 months

  12. ORR (Parts A and C)

    Percentage of participants with complete response or partial response among all response evaluable participants

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start23 Mar 2023
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion5 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
365 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669430
Sponsor's protocol ID
GV20-0251-100
Other IDs
GV20-0251-100, MK-3475-F77, KEYNOTE-F77
Status last verified
Feb 2025
First submitted
12 Dec 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Wu X, Sheng C, Liu H, Liu H, Tang Y, Liu C, Ding Q, Xie B, Xiao X, Zheng R, Yu Q, Guo Z, Ma J, Wang J, Gao J, Tian M, Wang W, Zhou J, Jiang L, Gu M, Shi S, Paull M, Yang G, Yang W, Landau S, Bao X, Hu X, Liu XS, Xiao T. IGSF8 is an innate immune checkpoint and cancer immunotherapy target. Cell. 2024 May 23;187(11):2703-2716.e23. doi: 10.1016/j.cell.2024.03.039. Epub 2024 Apr 23.

    PubMed 38657602

  • Wentzel, K., Peguero, J., Kummar, S., Lorusso, P., Mehnert, J. M., Spira, A. I., Naing, A., Hamid, O., Mehmi, I., Benhadji, K., Alland, L., Hu, X., Xiao, H., Bao, X., Chen, J., Gong, Y., Liu, X. S. ESMO 2024

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GV20-0251 and GV20-0251 and Pembrolizumab [KEYTRUDA®] in people with Solid Tumor, Adult and Refractory Cancer, run by GV20 Therapeutics at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GV20 Therapeutics (617-256-2846, clinicaltrials@gv20tx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate ORR per RECIST version 1.1 (Parts B and D) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669430, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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