What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as PD-1/PD-L1 inhibitors (e.g., pembrolizumab), often lead to immune-related adverse events (irAEs). These can include skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), and endocrine disorders (thyroid dysfunction). When combined with a CCR8 antibody like BAY3375968, additional side effects may include a reduction in regulatory T cells, potentially leading to enhanced immune responses and associated toxicities. Monitoring for these side effects is crucial to manage and mitigate potential risks.

What prior FDA approvals exist?

Pembrolizumab (Keytruda) and Ipilimumab (Yervoy) are FDA-approved immunotherapies for the treatment of various solid tumors, including melanoma and non-small cell lung cancer. These drugs enhance the immune system's ability to target and destroy cancer cells by inhibiting immune checkpoints such as PD-1 and CTLA-4. This mechanism is similar to the investigational drug BAY3375968, which aims to reduce regulatory T cells by targeting CCR8, thereby strengthening the immune response against cancer.

What other types of research exist?

Promising alternatives to BAY3375968 for solid tumor patients include: 1) Pembrolizumab (PD-1 inhibitor) combined with chemotherapy, which has shown efficacy in various solid tumors. 2) Nivolumab (PD-1 inhibitor) combined with ipilimumab (CTLA-4 inhibitor), which has demonstrated benefits in melanoma and renal cell carcinoma. 3) Atezolizumab (PD-L1 inhibitor) combined with bevacizumab (VEGF inhibitor), which has shown promise in renal cell carcinoma. 4) Relatlimab (LAG-3 inhibitor) combined with nivolumab, which has shown efficacy in melanoma. These therapies leverage different mechanisms to enhance the immune response against cancer cells.

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Monoclonal Antibodies

BAY3375968 + Pembrolizumab for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment)

Awards & highlights

Summary

This trial is testing a new antibody treatment, BAY3375968, for people with advanced cancers. The treatment aims to improve the immune system's ability to fight cancer by reducing specific cells that suppress immune response. Researchers will study its safety, the best dose, and how well it works alone and with another cancer drug, pembrolizumab.

Who is the study for?

This trial is for adults with advanced solid tumors that have spread and are not curable with existing treatments. Participants must be physically capable of daily activities (ECOG PS 0 or 1), have functioning organs, agree to use contraception if applicable, and not be pregnant or breastfeeding. They should have tried all other effective treatments without success.

What is being tested?

The study tests BAY3375968 alone and combined with Pembrolizumab in two parts: dose escalation to find the safest high dose, then dose expansion at this best dose focusing on lung, breast, head/neck cancer, and melanoma. It measures safety, tolerability, how the body processes the drug, optimal dosing levels, and anti-cancer effects.

What are the potential side effects?

Potential side effects include typical reactions from immunotherapy such as fatigue; skin reactions; digestive issues like nausea or diarrhea; potential immune-related problems affecting lungs or liver; infusion-related symptoms; changes in blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment up to end of safety follow-up (90 days (±7 days) after the last administration of study treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Objective response rate (ORR)

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468

40%

FATIGUE

37%

INFUSION RELATED REACTION

37%

NAUSEA

23%

DIARRHEA

23%

BACK PAIN

23%

ABDOMINAL PAIN

23%

ANOREXIA

20%

ARTHRALGIA

20%

COUGH

20%

NON-CARDIAC CHEST PAIN

17%

DYSPNEA

17%

CONSTIPATION

17%

CHILLS

17%

MYALGIA

13%

DIZZINESS

13%

HEADACHE

13%

PRURITUS

13%

RASH MACULO-PAPULAR

10%

ANEMIA

10%

URTICARIA

10%

SINUS TACHYCARDIA

10%

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY

10%

EDEMA LIMBS

10%

ALLERGIC REACTION

10%

ANXIETY

10%

LUNG INFECTION

10%

SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY

TUMOR PAIN

EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY

HYPERGLYCEMIA

PAIN

PELVIC PAIN

PRODUCTIVE COUGH

PLEURAL EFFUSION

VOICE ALTERATION

VOMITING

FEVER

FLATULENCE

CREATININE INCREASED

HYPERTHYROIDISM

NECK PAIN

DEPRESSION

FLU LIKE SYMPTOMS

LYMPHOCYTE COUNT DECREASED

DYSPEPSIA

FLUSHING

HYPONATREMIA

HYPOTHYROIDISM

URINARY TRACT INFECTION

MUSCLE WEAKNESS LOWER LIMB

ALKALINE PHOSPHATASE INCREASED

DYSPHAGIA

ESOPHAGITIS

GASTROESOPHAGEAL REFLUX DISEASE

OSTEONECROSIS OF JAW

BRONCHOSPASM

PNEUMONITIS

SORE THROAT

BLURRED VISION

GAIT DISTURBANCE

HEMORRHOIDS

POSTNASAL DRIP

PRESYNCOPE

ACUTE KIDNEY INJURY

PERIPHERAL MOTOR NEUROPATHY

DRY SKIN

FLASHING LIGHTS

HYPOMAGNESEMIA

HYPERTENSION

HYPOTENSION

SINUSITIS

SYNCOPE

HEARING IMPAIRED

RASH ACNEIFORM

SOMNOLENCE

COLITIS

HOT FLASHES

RESPIRATORY FAILURE

CONJUNCTIVITIS

MOVEMENTS INVOLUNTARY

NASAL CONGESTION

PARESTHESIA

VAGINAL INFECTION

GASTROINTESTINAL DISORDERS - OTHER, SPECIFY

NEUTROPHIL COUNT DECREASED

ALLERGIC RHINITIS

PAIN IN EXTREMITY

SEPSIS

BLOATING

DEHYDRATION

DRY MOUTH

INSOMNIA

MALAISE

PAIN OF SKIN

THROMBOEMBOLIC EVENT

TREMOR

WEIGHT GAIN

100%

80%

60%

40%

20%

Study treatment Arm

Imprime PGG 4 mg/kg

Imprime PGG 2 mg/kg

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion - Arm 2BExperimental Treatment2 Interventions

Disease-specific combination expansion with separate cohorts in 4 ICI-relapsed tumor types (NSCLC, TNBC, HNSCC, and melanoma)

Group II: Dose expansion - Arm 2AExperimental Treatment1 Intervention

BAY3375968 monotherapy-mode-of-action (monotherapy-MoA) expansion in subjects with one of the following tumor types: NSCLC (PD-L1 tumor proportion score \[TPS\] ≥50%), TNBC (PD-L1 combined positive score \[CPS\] ≥10), HNSCC (PD-L1 CPS ≥20), or melanoma (no PD-L1 cut-off). The tumors should have primary (ICI-refractory) or secondary (ICI-relapsed) resistance to prior ICI-therapy. The final decision on the enrolled tumor type is at the discretion of the Sponsor.

Group III: Dose escalation - Arm 1BExperimental Treatment2 Interventions

Dose escalation of BAY 3375968 in combination with pembrolizumab

Group IV: Dose escalation - Arm 1AExperimental Treatment1 Intervention

Dose escalation of BAY3375968 as monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2070

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often involve immunotherapies that enhance the body's immune response to cancer. PD-1/PD-L1 inhibitors, for example, block proteins that prevent immune cells from attacking cancer cells. BAY3375968, an investigational drug, targets the CCR8 protein on regulatory T cells, reducing their suppressive effect on the immune system and thereby strengthening the immune response against tumors. These mechanisms are vital for solid tumor patients as they can potentially improve the effectiveness of cancer treatments and lead to better clinical outcomes.

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