Clinical trial for Advanced Solid Tumor
Official title GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04977453
What this study is testing
What is GI-101?
GI-101 is an investigational IV infusion being studied for advanced solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe and well tolerated GI‑101/GI‑101A is, how it moves through the body, and whether it shows any activity against advanced or metastatic solid tumors.
- Who it's for
- It is for adults who have advanced or metastatic solid tumors such as cervical cancer, urothelial carcinoma, clear cell renal cell cancer, squamous cell non‑small cell lung cancer, or other solid tumors.
- What's involved
- Participants may receive GI‑101/GI‑101A alone or together with pembrolizumab or lenvatinib, and will have regular visits for treatment, safety checks, and blood tests to monitor the drug’s effects.
- Time commitment
- The study lasts several months, with multiple scheduled visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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. Key
- 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. Other protocol defined inclusion exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- Huntersville, North Carolina, United States
- Seoul, Banpo-daero, South Korea
- Seoul, Bundang-gu, South Korea
- Daejeon, Daejeon, South Korea
- Seoul, Gangnam, South Korea
- Suwon, Kyeonggi-do, South Korea
- Seoul, Seongbuk-gu, South Korea
- Seoul, Yangcheon-gu, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States; Huntersville, North Carolina, United States; Seoul, Banpo-daero, South Korea; Seoul, Bundang-gu, South Korea; Daejeon, Daejeon, South Korea; Seoul, Gangnam, South Korea and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.