A Study of GV20-0251 in Patients With Solid Tumor Malignancies

GV20 Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Endometrial Carcinoma; Head and Neck Carcinoma; Solid Tumor, Adult; Non-small Cell Lung Cancer; Refractory Cancer; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Cholangiocarcinoma; Bladder Urothelial Carcinoma; Cutaneous Melanoma

Treatments: Drug: GV20-0251

Study type: Interventional

Funder types: Industry

Identifiers

NCT05669430

GV20-0251-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Part A - Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: GV20-0251

Drug: GV20-0251

Part B - Multiple Expansion Cohorts

Experimental group

Description:

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 participants with selected malignancies.

Treatment:

Drug: GV20-0251

Drug: GV20-0251