[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

617-256-2846

Email address

clinicaltrials@gv20tx.com

Condition

Refractory Cancer,Solid Tumor, Adult

Treatment type

Interventional

Investigational product

GV20-0251

Phase

Phase 1

Sponsor

GV20 Therapeutics

ClinicalTrials.gov identifier

NCT05669430

Study number

GV20-0251-100

Understanding clinical trials

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About the study

This is a Phase 1 study of GV20-0251 being developed for the treatment of patients with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. >= 18 years of age
  2. previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
  3. refractory or intolerant to standard therapy(ies)
  4. one or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
  5. ECOG performance status of 0 or 1
  6. Life expectancy of >=12 weeks
  7. Disease-free of active second/secondary or prior malignancies for ≥ 2 years
  8. laboratory test results within the required parameters
  9. Women of child bearing potential (WOCBP) and men must agree to use adequate contraception
Exclusion criteria

  1. Participant with acute luekemia or CLL
  2. Participant with heart disease or unstable arrhythmia
  3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
  4. Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
  5. Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
  6. History of major organ transplant
  7. History of a bone marrow transplant
  8. Symptomatic central nervous system (CNS) malignancy or metastasis
  9. Serious nonmalignant disease
  10. Pregnant or nursing women
  11. Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
  12. 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
  13. Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
  14. Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
  15. Active substance abuse

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site