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

  • End date
    Dec 12, 2025
  • participants needed
  • sponsor
    GI Innovation, Inc.
Updated on 12 November 2021
measurable disease
HIV Infection
cancer chemotherapy


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


This is a phase 1/2, open-label, dose-escalation and expansion study to evaluate the safety, tolerability and anti-tumor effect of GI-101 as a single agent or in combination with pembrolizumab, lenvatinib or local RT over a range of advanced and/or metastatic solid tumors.

This study will comprise four parts.

  • Part A: Dose-escalation and expansion cohorts of GI-101 monotherapy
  • Part B: Dose-escalation and expansion cohorts of GI-101 plus pembrolizumab
  • Part C: Dose-optimization and expansion cohorts of GI-101 plus lenvatinib
  • Part D: Dose-optimization and expansion cohorts of GI-101 plus local RT

GI-101 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 (IgG4) Fc.

Drug Information available for: Pembrolizumab (, Lenvatinib (

Condition Non-Small Cell Lung Cancer, Adenocarcinoma, urinary tract neoplasm, Connective and Soft Tissue Neoplasm, Malignant neoplasm of kidney, bladder cancer, bladder disorder, melanoma, Renal Cell Carcinoma, skin cancer, Sarcoma, Advanced Solid Tumor, Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Metastatic Solid Tumor, Advanced Malignant Solid Tumor, Renal Cell Cancer, Bladder Carcinoma, clear cell renal cell carcinoma, carcinoma of the bladder, sarcomas, soft tissue sarcomas, nsclc, metastatic malignant solid tumor
Treatment Pembrolizumab, Lenvatinib, local radiotherapy, GI-101
Clinical Study IdentifierNCT04977453
SponsorGI Innovation, Inc.
Last Modified on12 November 2021


Yes No Not Sure

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

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 (except Part D)
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, pembrolizumab or lenvatinib
Other protocol defined inclusion exclusion criteria may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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