What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly those targeting specific pathways or mechanisms involved in tumor growth or survival, often have side effects such as fatigue, nausea, diarrhea, and hematologic toxicities like neutropenia and anemia. Targeted therapies can also cause specific organ toxicities, including cardiotoxicity and interstitial lung disease. Immune checkpoint inhibitors may lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors that target specific pathways involved in tumor growth and survival. Notable examples include tyrosine kinase inhibitors like cabozantinib (approved for medullary thyroid cancer) and immune checkpoint inhibitors such as pembrolizumab and nivolumab (approved for various cancers including non-small cell lung cancer and renal cell carcinoma). These drugs work by inhibiting key molecular targets or enhancing the immune system's ability to fight cancer, similar to the investigational approach of BNT152+153.

What other types of research exist?

Promising novel alternatives to BNT152+153 for solid tumor patients include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as seen in the KEYNOTE trials for various cancers. 2) Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy, particularly for non-small-cell lung cancer (NSCLC) as demonstrated in the IMpower trials. 3) Cabozantinib (Cabometyx) combined with immunotherapies like nivolumab (Opdivo) or atezolizumab, showing efficacy in renal cell carcinoma and other solid tumors. 4) Dabrafenib and trametinib combination for tumors with BRAFV600E mutations, as evidenced in the NCI-MATCH trial. These therapies target specific pathways and mechanisms involved in tumor growth and survival, offering potential alternatives for solid tumor treatment.

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BNT152+153 for Cancer

Phase 1

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

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

Must have

Adequate hematologic function at screening as determined by: White blood cell count (WBC) ≥ 3 × 10^9/L, Absolute neutrophil count ≥ 1.5 × 10^9/L (patient may not use granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) to achieve these WBC and absolute neutrophil count levels), Platelet count ≥ 100 × 10^9/L, Hemoglobin (Hgb) ≥ 9.0 g/dL.

Adequate hepatic function at screening as determined by: Total bilirubin ≤ 1.5 mg/dL (or ≤ 2.0 mg/dL for patients with known Gilbert's syndrome or liver metastasis), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 3 × ULN for patients with liver metastasis.

Must not have

Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T˗cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.

Receives concurrent systemic (oral or IV) steroid therapy >10 mg prednisone daily or its physiological equivalent for an underlying condition.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs, BNT152 and BNT153, in patients with advanced solid tumors who have no other treatment options. The goal is to find the safest and most effective dose by adjusting the amount given to patients over time.

Who is the study for?

Adults with advanced solid tumors that can't be surgically removed or have spread, and who've run out of standard treatment options. They must have a certain level of blood clotting ability, organ function, and agree to use effective birth control. Those with brain metastases may qualify if stable and not requiring steroids.

What is being tested?

The trial is testing BNT152+153 in patients with various solid tumors. It's an early-phase study to determine safe dosage levels (Part 1) and then find the best dose for future studies (Part 2). Patients will receive either BNT152 or BNT153 alone first, followed by a combination of both.

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to low blood counts, liver issues indicated by abnormal tests results, allergic reactions or other immune-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests meet the required levels for white blood cells, neutrophils, platelets, and hemoglobin.

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My liver is functioning well according to recent tests.

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My kidneys are functioning well enough for the trial.

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My cancer is advanced, cannot be surgically removed, and standard treatments are not suitable or effective for me.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.

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I am taking more than 10 mg of prednisone or a similar steroid daily for another health issue.

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I haven't had an IV infection treatment in the last 2 weeks.

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I need drainage for fluid build-up in my chest or abdomen.

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I haven't had cancer treatments like chemotherapy or immunotherapy close to starting this trial.

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I am unable to give consent for medical procedures.

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I have an autoimmune disease like lupus or MS, but not well-controlled type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by causal relationship to trial treatment

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Objective response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2C - BNT152+153Experimental Treatment2 Interventions

Escalating dose levels up to RP2D

Group II: Part 2B - BNT152+153Experimental Treatment2 Interventions

Escalating dose levels up to RP2D

Group III: Part 2A - BNT152+153Experimental Treatment2 Interventions

Escalating dose levels up to RP2D

Group IV: Part 2 - BNT152+153 - biomarker cohortExperimental Treatment2 Interventions

Group V: Part 1 group B BNT152Experimental Treatment1 Intervention

Monotherapy dose escalation.

Group VI: Part 1 group A BNT153Experimental Treatment1 Intervention

Monotherapy dose escalation.

0 / 12Eligibility criteria met

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

The most common treatments for solid tumors often involve targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors and monoclonal antibodies, work by specifically inhibiting pathways that are crucial for tumor cell proliferation and survival, such as the VEGF or EGFR pathways. Immunotherapies, including checkpoint inhibitors like anti-PD-1 or anti-CTLA-4 antibodies, enhance the body's immune response against tumor cells by blocking inhibitory signals that prevent immune cells from attacking the cancer. These mechanisms are crucial for solid tumor patients as they offer more precise and potentially less toxic treatment options compared to traditional chemotherapy, improving both efficacy and quality of life.