Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT05669430

Recrutement en cours

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

Interventionnel

Phase 1/2

Mass General Hospital

Sponsor: GV20 Therapeutics

Dernière synchronisation : 25 mars 2025

Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

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Catégorie de traitement

Autres médicaments, Inhibiteurs de points de contrôle

Mutations requises

Aucun

Essai commencé

23 mars 2023

Dernière mise à jour par le sponsor

25 mars 2025

Achèvement estimé

15 décembre 2026

Contact de l'étude

Nom:GV20 Therapeutics

E-mail:clinicaltrials@gv20tx.com

Téléphone:617-256-2846

Éligibilité

Critères d'inclusion

* 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

* 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)

Critères d'exclusion

* 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

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Détails de la conception

AllocationNon-Randomized

Modèle d'interventionSequential Assignment

MasquageNone (Open Label)

Nombre à inscrire365

Bras et interventions

Bras

Interventions

Type : Experimental

Description : 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).

Interventions :

GV20-0251
GV20-0251
GV20-0251 and Pembrolizumab [KEYTRUDA®]
GV20-0251 and Pembrolizumab [KEYTRUDA®]

Mesures des résultats

Mesures des résultats primaires

Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)12 months

ORR

Percentage of Participants With Adverse Events (Parts A and C)12 months

Mesures des résultats secondaires

Overall Survival (Parts B and D)24 months

Additional safety and tolerability24 months

TEAEs per NCI CTCAE version 5.0

Cmax of GV20-025112 months

Maximum concentration

Tmax of GV20-025112 months

Time to peak drug concentration

T1/212 months

Terminal half-life of GV20-0251

AUC12 months

Area under the curve

ADAs12 months

Specification and quantification of anti-drug antibodies

nADAs12 months

Neutralizing anti-drug antibodies

DCR24 months

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

DoR24 months

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

PFS24 months

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

ORR (Parts A and C)24 months

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

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Sites d'essai

Cette étude compte 13 sites d'essai

Mass General Hospital

Boston, Massachusetts, US

Nom:GV20 Therapeutics

E-mail:clinicaltrials@gv20tx.com

Recrutement en cours

Boston, Massachusetts, 02114 US

Mass General Hospital

Recrutement en cours

Houston, Texas, 77030 US

The University of Texas M. D. Anderson Cancer Center

Recrutement en cours

Portland, Oregon, 97239 US

Oregon Health & Science University

Recrutement en cours

Los Angeles, California, 90025 US

The Angeles Clinic and Research Institute

Recrutement en cours

Fairfax, Virginia, 22031 US

Virginia Cancer Specialists

Recrutement en cours

Houston, Texas, 77030 US

Oncology Consultants, P.A.

Recrutement en cours

New Haven, Connecticut, 06511 US

Yale University

Recrutement en cours

New York, New York, 10016 US

NYU Langone Health

Recrutement en cours

Indianapolis, Indiana, 46256 US

Community Health Network, Inc.

Pas encore en recrutement

Fort Myers, Florida, 33916 US

Florida Cancer Specialists & Research Institute, LLC

Recrutement en cours

Detroit, Michigan, 48201 US

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Pas encore en recrutement

Denver, Colorado, 80218 US

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

Pas encore en recrutement

Nashville, Tennessee, 37203 US

Verdi Oncology Tennessee, Scri Oncology Partners

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