What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as chemotherapy, radiation therapy, and targeted therapies, have several known side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Radiation therapy often leads to esophagitis, causing pain and difficulty swallowing, as well as fatigue and skin changes. Targeted therapies, like those inhibiting EGFR or HER2, can result in skin rashes, diarrhea, and liver function abnormalities. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of esophageal cancer, particularly focusing on immune checkpoint inhibitors. Pembrolizumab (Keytruda) has been approved for patients with recurrent locally advanced or metastatic squamous cell carcinoma (SCC) of the esophagus expressing high levels of PD-L1 (CPS ≥10) after progression on prior therapy. Nivolumab (Opdivo) is approved for advanced SCC of the esophagus after prior fluoropyrimidine- and platinum-based chemotherapy, regardless of PD-L1 expression status. These approvals highlight the role of immune checkpoint inhibitors in the treatment landscape of esophageal cancer.

What other types of research exist?

Promising novel alternatives to JAB-3312 for esophageal cancer patients include U3-1402, a HER3-targeting antibody-drug conjugate that has shown potent therapeutic efficacy and immune activation in cancer models, and CF33-hNIS-anti-PD-L1, an oncolytic chimeric poxvirus designed to treat cancers by modifying the tumor microenvironment and enhancing antitumor immunity.

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JAB-3312 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Must not have

Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).

Known malignant central nervous system disease other than neurologically stable, treated brain metastases.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Summary

This trial tests a new drug called JAB-3312, taken regularly, in about 24 participants. The goal is to find a safe dosage and understand potential side effects.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after standard treatment or lack a standard treatment option. They must be in relatively good health (ECOG score of 0 or 1), have a life expectancy of at least three months, and sufficient organ function. Tumors should be measurable by RECIST v1.1 criteria.

What is being tested?

The trial is testing JAB-3312, an oral medication for various advanced cancers. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest a Phase 2 dose (RP2D). Participants will take JAB-3312 daily in cycles of 21 days.

What are the potential side effects?

As this is a first-in-human study, specific side effects are not yet known but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, and potential drug-specific toxicities which will be monitored.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer has worsened despite treatment or there's no standard treatment for it.

Exclusion Criteria

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

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I have a severe autoimmune disease or need high-dose steroids.

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I have brain metastases but they are stable and treated.

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I have a history of serious eye inflammation or blood vessel problems.

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I haven't taken any cancer drugs or experimental drugs in the last 28 days, except for prostate cancer treatment.

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I have had lung conditions that needed steroids or procedures to remove fluid.

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I do not have any serious or active infections.

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I have had a bone marrow or organ transplant from another person.

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I have no major side effects from previous treatments.

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I haven't had radiation therapy in the last 28 days and don't expect to need it soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Find Recommended Phase 2 Dose (RP2D) of JAB-3312

Number of participants with dose limiting toxicities

Secondary study objectives

Area under the curve

Cmax

Duration of response ( DOR )

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: JAB-3312Experimental Treatment1 Intervention

JAB-3312 will be administered orally once daily in 21 days treatment cycles.

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 esophageal cancer include chemotherapy, targeted therapy, and chemoradiotherapy. Chemotherapy drugs like cisplatin, fluorouracil (5-FU), and paclitaxel work by interfering with DNA replication and cell division, leading to cancer cell death. Targeted therapies, such as those inhibiting the epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2), block specific molecules involved in tumor growth and progression. Chemoradiotherapy combines chemotherapy with radiation therapy to enhance the cytotoxic effects on cancer cells. These treatments are crucial for esophageal cancer patients as they aim to reduce tumor size, control disease spread, and improve survival rates. Understanding these mechanisms helps in tailoring personalized treatment plans and exploring new therapeutic options like JAB-3312, which may offer additional benefits in managing advanced solid tumors.