Recruiting
Phase 2

GB1211 vs. Pembrolizumab

Sponsor:

Providence Health & Services

Code:

NCT05913388

Conditions

Metastatic Melanoma

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GB1211

Pembrolizumab

Placebo

Study Details

Brief summary:

The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.

Conditions

Metastatic Melanoma

Head and Neck Squamous Cell Carcinoma

Study ID

NCT05913388

Start date

Feb 29, 2024

Status verified date

Apr, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GB1211 + Pembrolizumab

GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment.

placebo comparator: Pembrolizumab Monotherapy

Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment.

Interventions

GB1211

Administered orally twice daily at 100mg.

Pembrolizumab

Administered at a fixed dose of 200 mg every 3 weeks intravenously.

Placebo

Administered orally twice daily at 100mg.

Primary outcome measure

  • Overall response rate based on disease imaging [ Time Frame: From the date of randomization until the date of first documented progression, assessed up to 63 weeks. ]

Central Contacts and Locations

Central contacts

Chris Fountain, RN, ONC

503-215-2691Christopher.Fountain@providence.org

Locations

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Chris Fountain, RN

503-215-2691Christopher.Fountain@providence.org

Principal Investigator:

Brendan D. Curti, MD

More Information

Sponsor

Providence Health & Services

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • metastatic melanoma
  • head and neck squamous cell carcinoma
  • pembrolizumab
  • galecto
  • GB1211

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Providence Health & Services on 2026-04-13.