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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 belowSelect...
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:Select...
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.
Select...
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
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 moreAwards & 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
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.
Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology.
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Who is running the clinical trial?
Translational Research in OncologyOTHER
21 Previous Clinical Trials
6,607 Total Patients Enrolled
TORL Biotherapeutics, LLCLead Sponsor
5 Previous Clinical Trials
530 Total Patients Enrolled
Stephen Letrent, PharmD, PhDStudy DirectorTORL Biotherapeutics, LLC
6 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken cancer treatment drugs within the last 14 days for small molecules or 28 days for biologics.I do not have any serious illnesses or infections that are not under control.I am not pregnant or breastfeeding.I am fully active or can carry out light work.My organs are working well.I have a history of serious heart problems.I still have side effects from previous treatments, except for hair loss or acceptable lab results.My brain cancer is getting worse or causing symptoms.I have a history of myelodysplastic syndrome or acute myeloid leukemia.I haven't had cancer, except for certain skin cancers or low-risk cancers, in the last 3 years.My cancer is in an advanced stage and not just in one place.Your disease can be measured using a specific set of guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Dose Dose Finding - Part 1
- Group 2: Expansion as Monotherapy - Part 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.