What side effects are associated with this type of intervention?

Common treatments for Gastroesophageal Junction Adenocarcinoma include chemotherapy, targeted therapy, and immunotherapy. Treatments similar to the ADC being studied in the TORL-2-307-ADC trial include trastuzumab-based ADCs. The known side effects of these treatments often include diarrhea, fatigue, stomatitis, and nausea. Additionally, targeted therapies like ramucirumab can cause hypertension and thromboembolic events. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma include targeted therapies such as trastuzumab, which is used in combination with cytotoxic chemotherapy for HER2-positive tumors. While the context does not provide specific information on FDA-approved ADCs for GEJ adenocarcinoma, it mentions investigational approaches like the combination of trastuzumab with chemotherapy. Other approved treatments include ramucirumab, a monoclonal antibody targeting VEGFR-2, used in combination with paclitaxel for advanced cases. These therapies highlight the trend towards targeted treatments, similar to the investigational ADCs like TORL-2-307-ADC being studied.

What other types of research exist?

Promising novel alternatives to TORL-2-307-ADC for Gastroesophageal Junction Adenocarcinoma patients include: 1) HER2-targeted therapies such as trastuzumab conjugated with higher DARs of 4 and 8, which have shown enhanced antitumor activity in xenograft models. 2) Investigational agents targeting the PI3K/PTEN/AKT/mTOR pathway, such as temsirolimus and everolimus, which have shown some promise in clinical trials. 3) Pembrolizumab combined with chemotherapy, which has demonstrated efficacy in metastatic non-small-cell lung cancer and may be applicable to gastroesophageal cancers.

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Antibody-drug conjugate

TORL-2-307-ADC for Advanced Cancer

Phase 1

Recruiting

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

Has not recovered (recovery is defined as NCI CTCAE, version 5.0, grade ≤1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements

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-ADC in patients with advanced cancer to see if it is safe and can help fight their cancer.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific cancers of the stomach and pancreas. Participants must have measurable disease, be relatively fit (ECOG status 0-1), and have good organ function. They can't join if they've had recent cancer treatments, unresolved side effects from past therapies (except hair loss or certain lab abnormalities), brain metastases, serious heart conditions, other active cancers within the last 3 years (with some exceptions), or are pregnant/breastfeeding.

What is being tested?

The study is testing TORL-2-307-ADC's safety and effectiveness against advanced cancers. It's a first-in-human trial meaning it's the first time this drug is being tested in people to see how well it works and how safe it is.

What are the potential side effects?

Since this is a first-in-human study of TORL-2-307-ADC, potential side effects aren't fully known yet but may include typical reactions to cancer drugs such as nausea, fatigue, allergic reactions to the medication infusion itself, blood count changes increasing infection risk.

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 had cancer treatment with drugs or trials within the last 14 days for small molecules or 28 days for biologics.

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I still experience side effects from previous treatments, except for hair loss.

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

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I have a history of serious heart problems.

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I am not pregnant or breastfeeding.

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

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My brain cancer is getting worse or causing symptoms.

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-ADC

+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-ADC

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

TORL-2-307-ADC

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

The most common treatments for Gastroesophageal Junction Adenocarcinoma include chemotherapy, immunotherapy, targeted therapies, and antibody-drug conjugates (ADCs). Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while immunotherapy leverages the body's immune system to recognize and attack cancer cells. Targeted therapies, such as those inhibiting HER2, focus on specific molecular targets associated with cancer growth. ADCs, like the one studied in the TORL-2-307-ADC trial, combine an antibody specific to cancer cell antigens with a cytotoxic drug, allowing for precise delivery of the drug to cancer cells and reducing collateral damage to healthy tissues. These mechanisms are crucial for GEJ adenocarcinoma patients as they offer more effective and personalized treatment options, potentially improving outcomes and reducing side effects.