lanerkitug (BAY 3375968) / Bayer - LARVOL DELTA

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=129 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Jul 2026 ➔ Apr 2027

First-in-human • Monotherapy • Trial primary completion date • Breast Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=129 | Active, not recruiting | Sponsor: Bayer | Recruiting ➔ Active, not recruiting | N=354 ➔ 129

Enrollment change • Enrollment closed • First-in-human • Monotherapy • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=354 | Recruiting | Sponsor: Bayer | N=270 ➔ 354

Enrollment change • Metastases • Monotherapy • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=270 | Not yet recruiting | Sponsor: Bayer

Combination therapy • Monotherapy • New P1 trial • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=129 | Active, not recruiting | Sponsor: Bayer | Trial primary completion date: Oct 2026 ➔ Jul 2026

First-in-human • Monotherapy • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Bayer has cleared out four cancer candidates from its early-stage pipeline, including a STAT3 inhibitor acquired as part of its buyout of Vividion Therapeutics. (FierceBiotech) - "Vividion and Bayer 'made the strategic decision to discontinue the development' of VVD-130850 'based on the totality of the data, which includes safety, PK/PD and activity of the drug,'...The program consisted of a DGK-alpha inhibitor dubbed BAY 2862789 along with a DGKzeta Inhibitor called BAY 2965501....The final cancer drug thrown on the scrap heap was an anti-human CCR8 antibody called BAY 3375968 or lanerkitug."

Discontinued • P1 data • Colorectal Cancer • Melanoma • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Selective depletion of tumor-infiltrating regulatory T cells with BAY 3375968, a novel Fc-optimized anti-CCR8 antibody. (PubMed, Clin Exp Med) - P1 | "Collectively, these findings suggest that CCR8 targeting represents a promising strategy for Treg depletion in cancer therapies. BAY 3375968 is currently under investigation in a Phase I clinical trial (NCT05537740)."

Journal • Immunology • Oncology • CCR8