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A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.

ConditionsUterine Cervical NeoplasmsTriple Negative Breast NeoplasmsProstatic NeoplasmsSquamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell CarcinomaCholangiocarcinomaGallbladder NeoplasmsColorectal NeoplasmsPancreatic Ductal AdenocarcinomaCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGV20 Therapeutics

About this trial

This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.

Able and willing to participate in and comply with study procedures throughout the study.

Age ≥ 18 and ≤ 80 years, any gender.

Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.

Disqualifiers

Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase/lipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.

Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)

Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy > 30 Gy within 6 months prior to C1D1.

Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.

Trial design

Design model

Single group

Treatments tested in this trial

  • GV20-0251

    Drug

    GV20-0251 10/20 mg/kg or SRC-recommended dose in combination with anti-PD-1, Q3W; Part B: RP2D + standard dose anti-PD-1, Q3W.

  • anti-PD-1 monoclonal antibodies

    Drug

    anti-PD-1 monoclonal antibodies 200 mg IV Q3W; C1D1 infusion ≥ 60 min, subsequent infusions may be shortened to ≥ 30 min; administered prior to GV20-0251.

Treatment groups

227 Participants
are divided into 1 treatment group
Group A: GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody

Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) assessed by NCI CTCAE v5.0

Time frame
From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months
2

Evaluate the anti-tumor activity of GV20-0251 in combination with anti-PD-1 monoclonal antibody

Objective Response Rate (ORR) assessed by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)

Time frame
From Cycle 1 Day 1 dosing (each cycle is 21 days) until disease progression or end of study (whichever occurs first, up to 24 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GV20 Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: