GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

NCT05913388 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2023000353
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate based on disease imaging

  Determine the response of Gal-3 inhibitor and pembrolizumab versus pembrolizumab monotherapy (plus placebo) in patients with metastatic melanoma or head and neck squamous cell carcinoma (HNSCC).

  From the date of randomization until the date of first documented progression, assessed up to 63 weeks.

Secondary Outcomes (6)

• Evaluation of GAL-3 Expression

  Screening and Day 68

• Evaluation of Predictive Biomarker

  Day 85

• Frequency of Immune-mediated Adverse Events

  From the time of informed consent to week 63

• Evaluation of Antiviral Immunity

  Day 85

• Evaluation of Antiviral Immunity

  Day 85

Study Arms (2)

GB1211 + Pembrolizumab

EXPERIMENTAL

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

Drug: GB1211; Drug: Pembrolizumab

Pembrolizumab Monotherapy

PLACEBO COMPARATOR

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

Drug: Pembrolizumab; Drug: Placebo

Interventions

GB1211 DRUG

Administered orally twice daily at 100mg.

GB1211 + Pembrolizumab

Pembrolizumab DRUG

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

Also known as: Keytruda

GB1211 + Pembrolizumab; Pembrolizumab Monotherapy

Placebo DRUG

Administered orally twice daily at 100mg.

Pembrolizumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Galecto Biotech AB: collaborator
• Providence Health & Services: lead
• Providence Cancer Center: collaborator
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms

Study Officials

• Brendan D. Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Fountain, RN, ONC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 22, 2023
• Study Start: February 29, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)