GV20-0251 treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2A study evaluates GV20-0251, a novel treatment for patients with advanced solid tumors that have not responded to standard therapies. The study is structured in four parts, including dose escalation to determine safety and tolerability, and further assessment of anti-tumor activity in combination with Pembrolizumab. Participants will undergo a series of evaluations to establish the maximum tolerated dose and the pharmacokinetics of the treatment. The study aims to provide insights into the effectiveness of GV20-0251 both alone and in combination with an established immunotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• The Angeles Clinic and Research Institute
  Los Angeles, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Community Health Network, Inc.
  Indianapolis, Indiana, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
  Detroit, Michigan, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: GV20 Therapeutics
• Email: clinicaltrials@gv20tx.com
• Phone: 617-256-2846

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.