Study of GV20-0251 in Participants With Solid Tumor Malignancies

Study Purpose

This is a Phase 1 and Phase 2 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Before conducting any study-specific procedures, voluntarily sign an informed consent form.
  • - Be able and willing to participate throughout the entire study period and comply with study procedures.
  • - participants ≥18 years of age.
  • - Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the 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 before C1D1.
  • - Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible.
  • - Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters.
  • - Women of childbearing potential (WOCBP) and men must agree to use adequate contraception.

Exclusion Criteria:

  • - Participants with acute leukemia or CLL.
  • - Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia.
  • - Fridericia-corrected QT interval (QTcF) > 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.
  • - Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1.
  • - Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy.
  • - Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.
  • - History of major organ transplant and/or a bone marrow transplant.
  • - Symptomatic central nervous system (CNS) malignancy or metastasis.
  • - Serious nonmalignant disease.
  • - Pregnant or nursing women.
  • - Major surgery within 28 days prior to the first dose of study medication.
  • - Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.
  • - History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.
  • - Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.
  • - Active substance abuse.
- Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07070518
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GV20 Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumor Cancer, Adult Refractory Cancer, Endometrial Carcinoma (EC), Squamous Head and Neck Carcinoma, pMMR/MSS Adenocarcinoma of the Colon or Rectum, Non-Small Cell Lung Cancer, Melanoma, HCC - Hepatocellular Carcinoma, Small Cell Lung Cancer
Additional Details

This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B). Part A is a safety run-in portion. 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 Simon 2-stage design 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.

Arms & Interventions

Arms

Experimental: GV20-0251

Interventions

Drug: - GV20-0251

Part A: Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks Part B: GV20-0251 preliminary RP2D administered by IV infusion once every 3 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing 1816670, Beijing Municipality 2038349, China

Status

Recruiting

Address

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing 1816670, Beijing Municipality 2038349,

Site Contact

Ning Jiang, MD

[email protected]

010-87788165

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