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A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

ConditionsSolid Tumor, AdultRefractory CancerEndometrial Carcinoma (EC)Squamous Head and Neck CarcinomapMMR/MSS Adenocarcinoma of the Colon or RectumCutaneous MelanomaNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGV20 Therapeutics

About this trial

This is a Phase 1/2A 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • GV20-0251

    Biological/Vaccine

    Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.

  • GV20-0251

    Biological/Vaccine

    GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.

  • GV20-0251 and Pembrolizumab [KEYTRUDA®]

    Biological/Vaccine

    GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

  • GV20-0251 and Pembrolizumab [KEYTRUDA®]

    Biological/Vaccine

    GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

Treatment groups

365 Participants
are divided into 4 treatment groups
Group A: Part A - Dose Escalation in up to 7 dose levelsExperimental treatment 1 intervention
Group B: Part B - Multiple Expansion Cohorts in up to 4 tumor indicationsExperimental treatment 1 intervention
Group C: Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levelsExperimental treatment 1 intervention
Group D: Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indicationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)

ORR

Time frame
12 months
2

Percentage of Participants With Adverse Events (Parts A and C)

Time frame
12 months

Secondary outcomes

1

Overall Survival (Parts B and D)

OS

Time frame
24 months
2

Additional safety and tolerability

TEAEs per NCI CTCAE version 5.0

Time frame
24 months
3

Cmax of GV20-0251

Maximum concentration

Time frame
12 months
4

Tmax of GV20-0251

Time to peak drug concentration

Time frame
12 months

Other outcomes

Sponsors and contacts

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

GV20 Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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