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New drug combo shows promise for Hard-to-Treat cancers

NCT ID NCT04977453

Disease control Sponsor: GI Innovation, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study is testing a new experimental drug called GI-101, given alone or with pembrolizumab or lenvatinib, in people with advanced or metastatic solid tumors (cancers that have spread). The goal is to see if the drug is safe and can shrink or control tumors. About 317 adults with certain cancers like lung, kidney, or cervical cancer are being enrolled. This is an early-phase trial, so the main focus is safety and finding the right dose.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 317 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion 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 Exclusion Criteria: * 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. Cancer type and part-specific inclusion criteria are described in the study protocol.

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Conditions

The condition(s) this trial relates to.

cervical cancer clear cell renal carcinoma cutaneous neuroendocrine carcinoma esophageal squamous cell carcinoma head and neck squamous cell carcinoma melanoma metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma non-small cell squamous lung carcinoma renal cell carcinoma sarcoma transitional cell carcinoma urinary bladder cancer urothelial carcinoma Uterine Cervical Neoplasms vaginal cancer vulva cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Cervical cancer Clear cell renal cell cancer (CCRCC) Esophageal squamous cell carcinoma Head and neck squamous cell carcinoma Melanoma Merkel cell carcinoma Metastatic solid tumor Microsatellite stable colorectal carcinoma Non-small cell lung cancer Renal cell carcinoma Sarcoma Squamous cell non small cell lung cancer Urinary bladder cancer Urothelial carcinoma Vaginal cancer Vulvar cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Carolina Biooncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, Daejeon, 65015, South Korea

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Ewha Womans University Mokdong Hospital

    RECRUITING

    Seoul, Yangcheon-gu, 07985, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seongbuk-gu, 02841, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, Gangnam, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seoul, Bundang-gu, 13620, South Korea

  • The Catholic University of Korea Seoul ST.MARY'S Hospital

    RECRUITING

    Seoul, Banpo-daero, 06591, South Korea

  • The Catholic University of Korea St. Vincent's Hospital

    RECRUITING

    Suwon, Kyeonggi-do, 16247, South Korea

  • Tisch Cancer Institute (TCI), Icahn School of Medicine

    RECRUITING

    New York, New York, 10029-5674, United States

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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Other studies related to the condition(s) this trial covers.