Overview
This is a Phase 1 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.
Description
This is a Phase 1 non-randomized, open label, multi-center study to be conducted in two parts (Parts A and B).
Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities and to establish the maximum tolerated dose and/or the recommended Phase 2 dose of GV20-0251.
Part B consists of multiple expansion cohorts in which eligible participants will be treated at the recommended Phase 2 dose of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in patients with selected malignancies.
The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit, Safety Follow-Up Period and a Survival Follow-Up Period.
Eligibility
Inclusion Criteria:
- >= 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
- One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
- 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
- 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
- Part B ONLY must include the following tumor types:
- Cohort B1: bladder urothelial carcinoma
- Cohort B2: cholangiocarcinoma
- Cohort B3: proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum
- Cohort B4: proficient MMR (pMMR)/MSS endometrial carcinoma
- Cohort B5: deficient MMR (dMMR)/MSI-H endometrial carcinoma
- Cohort B6: squamous head and neck carcinoma
- Cohort B7: cutaneous melanoma
- Cohort B8: non-small cell lung cancer
Exclusion Criteria:
- Participant with acute luekemia or CLL
- 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
- Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- 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
- Active substance abuse