GV20-0251 in Advanced and/or Refractory Solid Tumor Malignancies

What is the Purpose of this Study?

The purpose of the study is to determine whether an experimental drug called GV20-0251 is safe and tolerable in patients with solid tumors that have not been successfully treated with standard therapies. GV20-0251 is a monoclonal antibody, which is a type of protein made in a laboratory; it will be given as an injection. The study will be conducted in two parts: Part A and Part B. The purpose of Part A is to determine the dose level to be studied in Part B. The purpose of Part B is to further study the safety and activity of GV20 0251 administered as an IV infusion in certain tumor types at the selected dose levels from Part A. Researchers will also conduct laboratory tests and/or measure tumor changes during Part B.

Eligibility

* 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

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)
* 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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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

GV20-0251-100: An Open-Label Study of GV20-0251 in Patients with Advanced and/or Refractory Solid Tumor Malignancies

Study Details

Disease Type/Condition

Breast cancer, Colon cancer, Lung Cancer, Melanoma, Rectal Cancer, Solid Tumors

Principal Investigator

Wentzel, Kristopher

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

IRB Number

STUDY00002608

ClinicalTrials.gov ID

NCT05669430

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org