RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 1/2A study tests GV20-0251 alone and with pembrolizumab. It is for adults with advanced solid tumors that have grown after treatment and who cannot use standard treatments or whose cancer has not responded to them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with an advanced solid tumor confirmed by a tissue test. The cancer must have grown after treatment and need more treatment.
  • Standard treatments must not have worked or caused side effects you could not tolerate. You must have received, been unable to receive, or declined standard care.
  • Have cancer that can be measured on scans. If you had an immune checkpoint drug, which helps the immune system fight cancer, records must show that the cancer grew.
  • Be fully active or able to do light work, even if you cannot do hard physical activity.
  • Be expected to live at least 12 weeks for Parts A and C, or 24 weeks for Parts B and D.
  • Be willing to give a fresh tumor tissue sample before treatment, if medically possible. Parts A and B also require a sample during treatment.
  • Have no active other cancer for at least 2 years, and have blood and other lab test results within the study's required limits.
  • Men and women who could become pregnant must agree to use suitable birth control.

Who can't join

  • Have heart disease, an unstable heartbeat, a serious illness other than cancer, or an uncontrolled infection needing treatment throughout the body.
  • Have an active disease in which the immune system attacks the body, or need long-term steroids or drugs that weaken the immune system. Past major organ or bone marrow transplants also exclude you.
  • Have cancer in the brain or spinal cord that causes symptoms, or cancer spread to the liver without study sponsor approval. Certain blood cancers exclude people from Parts A and B.
  • Be pregnant or breastfeeding, or have active substance abuse.
  • Be receiving another study drug or have received one within 4 weeks, or cancer treatment within 2 weeks, before the first study dose. Prior immune treatments, major surgery, and radiation also have restrictions.
  • Have had a severe immune-related side effect from cancer immune treatment, or another cancer that is growing or needed treatment in the past 2 years.
  • For Parts C and D: have a severe allergy to pembrolizumab or its ingredients, current lung inflammation, or past noninfectious lung inflammation that needed steroids. People with non-small cell lung cancer also have limits on recent lung radiation.
  • For Parts C and D: have a condition, treatment, test result, or other situation that the study doctor believes could affect the results or prevent full participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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) 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

Study sites (13)

CA

CO

  • HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE · Denver, CO 80218GV20 Therapeutics · Study contact · clinicaltrials@gv20tx.comJason Henry, MD · Principal investigatorMore trials in Denver

CT

FL

IN

MA

MI

NY

OR

TN

TX

VA