What is the mechanism of action of this treatment?

Common treatments for esophageal cancer include chemotherapy, which uses cytotoxic drugs to kill rapidly dividing cancer cells, and radiation therapy, which uses high-energy radiation to damage the DNA of cancer cells, leading to cell death. Targeted therapies, such as immune checkpoint inhibitors, work by blocking proteins that prevent the immune system from attacking cancer cells. The bi-specific ligand conjugated drug CBP-1019, currently under study, targets two different ligands or receptors, potentially increasing its efficacy by simultaneously disrupting multiple cancer cell survival pathways. This multi-target approach could be particularly beneficial for esophageal cancer patients with advanced solid tumors, as it may overcome resistance mechanisms and improve treatment outcomes.

What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as chemotherapy and radiation therapy, often result in side effects including nausea, vomiting, diarrhea, fatigue, and loss of appetite. Chemotherapy drugs like docetaxel, cisplatin, and fluorouracil can cause additional side effects such as hair loss, mouth sores, and increased risk of infection due to lowered white blood cell counts. Radiation therapy can lead to esophagitis, causing pain and difficulty swallowing. Bi-specific ligand conjugated drugs, like CBP-1019, may also cause similar side effects, along with potential immune-related reactions due to their targeted action on specific receptors.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments for esophageal cancer that specifically involve bi-specific ligand conjugated drugs like CBP-1019. However, the FDA has approved several other treatments for esophageal cancer, including chemotherapeutic agents such as fluorouracil, cisplatin, and docetaxel, as well as targeted therapies like trastuzumab for HER2-positive tumors and immunotherapies such as pembrolizumab for PD-L1 positive tumors. These treatments focus on different mechanisms, including chemotherapy, targeted therapy, and immunotherapy, to manage advanced esophageal cancer.

What other types of research exist?

Anlotinib monotherapy is a promising novel alternative for patients with advanced esophageal squamous cell carcinoma (ESCC). It has demonstrated promising efficacy and a tolerable toxicity profile in a real-world exploratory study. Other potential alternatives could include emerging immunotherapies and targeted therapies under investigation, although specific names are not provided in the context.

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Bi-specific Ligand Conjugated Drug

CBP-1019 for Advanced Cancers

Phase 1 & 2

Recruiting

Led By Lin Shen, MD

Research Sponsored by Coherent Biopharma (Hefei) Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Pathologically documented advanced solid tumor, including but not limited to advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer, etc

Must not have

Fever >38.5 °C of unknown cause

Positive Hepatitis B Surface Antigen (HbsAg) and Hepatitis B virus (HBV) DNA ≥ 500 IU/mL or 2500 copies or lower limits of normal (LLN) of positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CBP-1019, a drug that targets cancer cells, in patients with advanced solid tumors who have no other treatment options. The drug works like a guided missile, finding and attacking cancer cells more precisely.

Who is the study for?

Adults over 18 with advanced solid tumors, including lung, pancreatic, colorectal, esophageal, and breast cancer. They must have tried standard treatments or be unsuitable for them. Participants need a life expectancy of at least 3 months and good performance status (able to carry out daily activities). Tumor tissue is required for testing specific receptors. Women who can bear children and men with partners who can must use approved contraception.

What is being tested?

The trial tests CBP-1019's safety and effectiveness in treating various advanced cancers. It aims to find the best dose for phase II trials. Patients will receive CBP-1019 to see how well it works against their cancer and what side effects it may cause.

What are the potential side effects?

Potential side effects of CBP-1019 are not specified but could include typical reactions seen with cancer therapies such as fatigue, nausea, organ inflammation or immune system reactions given its bi-specific ligand drug nature.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I have an advanced solid tumor, such as lung, pancreatic, or breast cancer.

Exclusion Criteria

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

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I have had a fever over 38.5°C without knowing why.

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I have an active Hepatitis B infection with specific virus levels.

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All my side effects from cancer treatment are mild, except for hair loss and tiredness.

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My heart condition severely limits my physical activity.

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I had treatment for stomach or intestinal ulcers, perforations, or fistulas in the last 6 months.

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My cancer has spread to my brain or spinal cord.

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I have a history of serious blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Incidence and severity of Adverse Events (AEs)

Secondary study objectives

MTD/RP2D of CBP-1019.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapyExperimental Treatment1 Intervention

Ia:Patients will receive CBP-1019 IV infusion every 2 weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. Ib:Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

0 / 9Eligibility 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

Common treatments for esophageal cancer include chemotherapy, which uses cytotoxic drugs to kill rapidly dividing cancer cells, and radiation therapy, which uses high-energy radiation to damage the DNA of cancer cells, leading to cell death. Targeted therapies, such as immune checkpoint inhibitors, work by blocking proteins that prevent the immune system from attacking cancer cells. The bi-specific ligand conjugated drug CBP-1019, currently under study, targets two different ligands or receptors, potentially increasing its efficacy by simultaneously disrupting multiple cancer cell survival pathways. This multi-target approach could be particularly beneficial for esophageal cancer patients with advanced solid tumors, as it may overcome resistance mechanisms and improve treatment outcomes.