GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
GI Innovation, Inc.
Study ID
NCT04977453
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GI-101 — DRUG
    Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
  • Pembrolizumab (KEYTRUDA®) — DRUG
    Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
  • Lenvatinib — DRUG
    Lenvatinib will be administered at an approved dose orally.
  • GI-101A — DRUG
    Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.

Key Dates

Start date
Aug 2, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
317 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GI-101
    Dose escalation: GI-101, multiple ascending doses Dose expansion:
  • Experimental: GI-101 + Pembrolizumab
    Dose escalation: GI-101, multiple ascending doses Dose expansion:
  • Experimental: GI-101 + Lenvatinib
    Dose optimization: Dose expansion:
  • Experimental: GI-101A
    Dose escalation: GI-101A, multiple ascending doses
  • Experimental: GI-101A + Pembrolizumab
    Dose escalation: GI-101A, multiple ascending doses Dose optimization Indication-specific cohorts

Primary Outcome Measure

Incidence and nature of Dose-Limiting Toxicity (DLTs), Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) [ Time Frame: Study Day 1, assessed up to approximately 24 months ]

Central Contacts

  • Recruiting sites have contact information. Please contact the sites directly.
    +8224042003
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Tisch Cancer Institute (TCI), Icahn School of MedicineNew YorkNew York10029-5674
Thomas Marron, MD, PhD (PRINCIPAL_INVESTIGATOR)
Carolina Biooncology InstituteHuntersvilleNorth Carolina28078
John Powderly, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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