Back to search results

GI-101/GI-101A for Advanced Solid Tumors

This study is testing new treatments, GI-101 and GI-101A, for people with advanced or metastatic (spread to other parts of the body) solid tumors, including cervical cancer, urothelial carcinoma, and clear cell renal cell cancer. Researchers want to see how safe these drugs are, how well your body handles them, and if they can shrink tumors. GI-101 and GI-101A will be given alone or in combination with pembrolizumab (KEYTRUDA®) or lenvatinib. The study will measure side effects and how many patients respond to the treatment. You may be able to join if you are 18 or older, have measurable disease, and good organ function. The study aims to enroll 317 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to find the best dose and then expand to more patients.
What's involved
GI-101 or GI-101A will be given through an IV every three weeks for up to two years. Pembrolizumab will also be given via IV every three weeks, and lenvatinib will be taken by mouth.
Compensation
Not stated in the trial record.
Follow-up
Your health and any side effects will be monitored for up to approximately 24 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04977453

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GI Innovation, Inc.
~317 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:GI-101Pembrolizumab (KEYTRUDA®)LenvatinibGI-101A

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and nature of Dose-Limiting Toxicity (DLTs), Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs)
Measured over Study Day 1, assessed up to approximately 24 months
+1 more outcome measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor
Cervical Cancer
Urothelial Carcinoma
Clear Cell Renal Cell Cancer (ccRCC)
Squamous Cell Non Small Cell Lung Cancer

Explore related trials

Cervical CarcinomaClear Cell Renal Cell CancerLung Non-Small Cell Squamous CarcinomaSolid NeoplasmUrothelial Carcinoma

Where it's being run

12 sites across 10 states
South Korea3
New York1
North Carolina1
Banpo-daero1
Bundang-gu1
Daejeon1
Gangnam1
Kyeonggi-do1

Study leadership

  • Nari Yun, PhD · STUDY_DIRECTOR · GI Innovation

Who to contact

Recruiting sites have contact information. Please contact the sites directly.
[email protected]
+8224042003
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
Has adequate organ and marrow function as defined in protocol.
Measurable disease as per RECIST v1.1.
ECOG performance status 0-1.
Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.
HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.

Exclusion

Has known active CNS metastases and/or carcinomatous meningitis.
An active second malignancy
Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
Has active tuberculosis or has a known history of active tuberculosis
Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Previous immunotherapies related to mode of action of GI-101.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
Known hypersensitivity to any of the components of the drug products and/or excipients of GI-101/GI-101A, pembrolizumab or lenvatinib.

What this trial measures

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

    Dose escalation and optimization phase of Part A, B, and C and Dose escalation phase of Part E and F

  • Objective Response Rate (ORR), Disease Control Rate (DCR) and Duration of Response (DoR) according to RECIST version 1.1Study Day 1, assessed up to approximately 24 months

    Based on Central review (Part G1) and Investigator review (Part G2) of radiographic imaging in Part G1 Dose optimization cohorts, Part G2 Indication-specific cohorts ORR only; Based on Investigator review of radiographic imaging in dose expansion phase of Part A, B and C