Could a Sugar-Blocking pill boost immunotherapy for tough cancers?
NCT ID NCT05913388
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether adding an experimental pill (GB1211) to the immunotherapy drug pembrolizumab (Keytruda) works better than Keytruda alone for people with advanced melanoma or head and neck cancer. The study will enroll 92 participants and measure how many patients' tumors shrink. GB1211 targets a protein called galectin-3, which may help cancer hide from the immune system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GB1211 (a galectin-3 inhibitor) and pembrolizumab (Keytruda)
- What this could lead to
- If it works, this combination could improve tumor shrinkage rates for people with advanced melanoma or head and neck cancer who have already tried standard treatments.
- What could go wrong
- This is a mid-stage trial with only 92 participants, so results may not apply to everyone. Adding GB1211 could also increase side effects without improving outcomes.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Feb 2024
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
-
Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: * Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers. * Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible. * Patients must be ≥ 18 years of age. * ECOG performance status of 0-2. * Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy. * No active bleeding. * Anticipated lifespan greater than 12 weeks. * Patients must sign a study-specific consent document. Exclusion Criteria: * Patients who have previously received a galectin antagonist. * Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo. * Patients with history of autoimmune colitis. * Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible. * Patients requiring other systemic oncologic therapy, including experimental therapies. * Patients who have received anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose. * Patients with Child-Pugh C hepatic impairment. * Patients with active infection requiring antibiotics. * Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. * Need for steroids at greater than physiologic replacement doses. Inhaled corticosteroids are acceptable. * Laboratory exclusions (to be performed within 28 days of enrollment): * WBC \< 3.0 x 109/L * Hgb \< 9.0 g/dL * AST or ALT \> 1.5 times ULN * Total bilirubin \> 1.9 g/dL, unless due to Gilbert's Syndrome. If Gilbert's Syndrome is present by clinical history, then direct bilirubin must by \< 3.0 g/dl. * Active or known history of HIV * Active or known history of Hepatitis B * Active or known history of Hepatitis C * Platelet counts \< 100 x 10E9 / L (100,000/ μL) without transfusion * INR \> 1.5x ULN * Inability to give informed consent and comply with the protocol. Patients must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. * Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures. * Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Providence Portland Medical Center
Portland, Oregon, 97213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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