What side effects are associated with this type of intervention?

Common treatments for Gastroesophageal Junction Adenocarcinoma include monoclonal antibodies such as trastuzumab and pembrolizumab. Known side effects of these treatments can include fatigue, nausea, diarrhea, and infusion-related reactions. More severe side effects may involve immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of Gastroesophageal Junction (GEJ) Adenocarcinoma. Notably, nivolumab, an anti-PD-1 monoclonal antibody, has been approved as adjuvant therapy for patients with residual disease following neoadjuvant chemoradiotherapy and complete resection. Additionally, trastuzumab, a monoclonal antibody targeting HER2, is used in combination with chemotherapy for HER2-positive advanced gastric and GEJ adenocarcinomas. These approvals highlight the role of targeted monoclonal antibody therapies in managing GEJ adenocarcinoma.

What other types of research exist?

Promising novel alternatives to TORL-2-307-MAB for Gastroesophageal Junction Adenocarcinoma patients include: 1) MEDI3622, a monoclonal antibody targeting ADAM17, which has shown efficacy in combination with cetuximab in esophageal models. 2) Pembrolizumab, an anti-PD-1 antibody, which is being investigated in combination with cetuximab for refractory solid tumors. 3) Avelumab, an anti-PD-L1 antibody, which has shown durable responses in other cancer types and may be considered for gastroesophageal junction adenocarcinoma.

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Monoclonal Antibodies

TORL-2-307-MAB for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by TORL Biotherapeutics, LLC

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 0-1

Advanced solid tumor

Must not have

Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-MAB

Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug called TORL-2-307-MAB in patients with advanced cancer. It aims to see if the drug is safe, how the body handles it, and if it can help fight tumors.

Who is the study for?

This trial is for adults with advanced solid tumors, including pancreatic, stomach, and gastroesophageal junction adenocarcinoma. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They can't join if they've had certain blood cancers, untreated brain metastases, unresolved toxic effects from past treatments (except hair loss), recent cancer therapies within the last 14 to 28 days depending on the therapy type, serious health issues or infections, are pregnant/breastfeeding, have significant heart disease or another cancer within the last three years.

What is being tested?

The study tests a new drug called TORL-2-307-MAB for safety and effectiveness against advanced cancers. It's a first-in-human study which means it's the first time this drug is being tried in people. The trial will also look at how the body processes the drug and its impact on tumor size.

What are the potential side effects?

Since this is a first-in-human study of TORL-2-307-MAB for advanced cancers, potential side effects are not yet fully known but may include typical reactions related to immune-based therapies such as fatigue, nausea, inflammation-related symptoms or allergic reactions.

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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My cancer is in an advanced stage and not just in one place.

Exclusion Criteria

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

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I haven't taken cancer treatment drugs within the last 14 days for small molecules or 28 days for biologics.

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I do not have any serious illnesses or infections that are not under control.

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I am not pregnant or breastfeeding.

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I have a history of serious heart problems.

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My brain cancer is getting worse or causing symptoms.

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I have a history of myelodysplastic syndrome or acute myeloid leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

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

Incidence and severity of adverse events and serious adverse events

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

1 Year Overall Survival (1YOS)

2 Year Overall Survival (2YOS)

Accumulation ratio (Rac) of TORL-2-307-MAB

+17 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy Dose Dose Finding - Part 1Experimental Treatment1 Intervention

TORL-2-307-MAB

Group II: Expansion as Monotherapy - Part 2Experimental Treatment1 Intervention

TORL-2-307-MAB

0 / 8Eligibility 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

Monoclonal antibodies, such as those being studied in the TORL-2-307-MAB trial, target specific antigens on cancer cells, such as HER2 or PD-1/PD-L1. These therapies work by binding to these antigens, thereby blocking the signals that promote cancer cell growth and survival. For example, trastuzumab targets HER2, a protein overexpressed in some GEJ adenocarcinomas, leading to inhibited tumor growth. Similarly, immune checkpoint inhibitors like pembrolizumab target PD-1/PD-L1, enhancing the immune system's ability to attack cancer cells. These targeted treatments are significant for GEJ adenocarcinoma patients as they offer a more personalized approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.