What side effects are associated with this type of intervention?

Common treatments for colorectal cancer that are similar to ATRC-101, which involves IgG1 antibodies targeting specific antigens, often include immunotherapy and antibody-based treatments. These treatments can lead to immune-related adverse events (irAEs) such as colitis, dermatitis, hepatitis, and endocrinopathies. Patients may also experience fatigue, infusion-related reactions, and gastrointestinal symptoms like nausea and diarrhea. Severe but less common side effects can include pneumonitis and myocarditis.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer that involve monoclonal antibodies targeting specific antigens to elicit an immune response. Cetuximab, an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR), is approved for metastatic colorectal cancer, particularly in patients who have failed irinotecan-based chemotherapy. Another example is pembrolizumab, a PD-1 inhibitor, which has shown efficacy in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. These treatments, like ATRC-101, leverage the immune system to target cancer cells, although they focus on different antigens and pathways.

What other types of research exist?

Promising novel alternatives to ATRC-101 for colorectal cancer patients include: 1) Pembrolizumab (PD-1 inhibitor) which has shown efficacy in various cancers including colorectal cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 2) Nivolumab (PD-1 inhibitor) often used in combination with other agents for enhanced efficacy. 3) Atezolizumab (PD-L1 inhibitor) which is being evaluated in combination with other therapies. 4) CAR-T cell therapies targeting specific antigens expressed in colorectal cancer. These alternatives leverage the immune system to target and destroy cancer cells, similar to ATRC-101.

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Monoclonal Antibodies

ATRC-101 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Atreca, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ATRC-101, a specially designed antibody, in adults with advanced cancers that haven't responded well to other treatments. ATRC-101 helps the immune system find and attack cancer cells. ATRC-101 has shown strong antitumor activity and evidence of immune memory in early studies.

Who is the study for?

Adults with certain advanced cancers (like breast, lung, colorectal, ovarian cancer or melanoma) that can't be removed by surgery or have spread and don't respond to standard treatments. They must have measurable disease and adequate organ function. Women who can bear children and men with partners of this potential must use effective birth control.

What is being tested?

ATRC-101 is being tested alone or with other cancer drugs (Pembrolizumab/PLD). This trial checks its safety, how the body handles it, and if it works against cancer when given every 2 or 3 weeks. It's an early-phase study where everyone gets the experimental treatment.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions which could happen during drug administration, fatigue, blood disorders like changes in cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: ATRC-101 Q3W + PembrolizumabExperimental Treatment2 Interventions

Pembrolizumab 200mg IV Q3W or 400mg IV Q6W

Group II: ATRC-101 Q3WExperimental Treatment1 Intervention

Group III: ATRC-101 Q2W + Pegylated liposomal doxorubicin (PLD)Experimental Treatment2 Interventions

PLD 40mg/m\^2 IV Run-in period of 28 days, and then 40mg/m\^2 IV Q4W

Group IV: ATRC-101 Q2WExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Pegylated liposomal doxorubicin (PLD)

2015

Completed Phase 3

~1060

Do I qualify?Apply below to find out

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 colorectal cancer include immunotherapy and targeted therapies. Immunotherapy, such as immune checkpoint inhibitors, works by enhancing the body's immune response against cancer cells. These inhibitors block proteins like PD-1/PD-L1, which cancer cells use to evade the immune system. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell antigens or pathways critical for tumor growth and survival. For example, cetuximab targets the epidermal growth factor receptor (EGFR) on cancer cells, inhibiting their growth. These treatments are crucial for colorectal cancer patients as they offer more personalized and effective options, especially for those who do not respond to traditional chemotherapy.