What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as oxaliplatin-based chemotherapy and fluoropyrimidines (e.g., fluorouracil and capecitabine), are associated with several side effects. Oxaliplatin can cause neuropathy, which may persist in some patients even after discontinuation. Fluoropyrimidines can lead to gastrointestinal issues like diarrhea, nausea, vomiting, and stomatitis, as well as hand-foot syndrome, particularly with capecitabine. Additionally, treatment-related deaths, although rare, can occur, especially in patients with dihydropyridine dehydrogenase (DPD) deficiency. Biologic agents like bevacizumab, when combined with chemotherapy, can also contribute to these side effects and may cause additional issues such as hypertension and increased risk of bleeding.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapy regimens and targeted therapies. FOLFIRI, a combination of folinic acid, fluorouracil (5-FU), and irinotecan, is a standard chemotherapy regimen. Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is often used in combination with chemotherapy to inhibit tumor blood vessel growth. Other notable FDA-approved treatments include oxaliplatin-based regimens like FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and targeted therapies such as cetuximab and panitumumab, which target the epidermal growth factor receptor (EGFR). These treatments aim to control tumor growth and improve survival rates in patients with metastatic colorectal cancer.

What other types of research exist?

Promising novel alternatives to Aplitibart for colorectal cancer patients include: <ol> <li>FOLFOX plus bevacizumab: This combination has shown objective responses and prolonged progression-free survival in clinical trials.</li> <li></li> </ol> Capecitabine plus bevacizumab: Demonstrated high tumor control rates and median progression-free survival in phase II trials. 3. Immunotherapy combinations: While single-agent immune checkpoint inhibitors have limited activity, combinations with other immune-modulating agents show promise and are under investigation. 4. Targeted therapies: Agents like surufatinib and lenvatinib have shown efficacy in other gastrointestinal cancers and may be considered for colorectal cancer pending further studies.

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Chemotherapy

Aplitibart for Metastatic Colorectal Cancer

Verified Trial

Phase 1

Waitlist Available

Eligibility Criteria Checklist

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

Must have

Have you received just one prior systemic therapy (e.g., Chemotherapy, Hormone Therapies, Immunotherapies) to treat your metastatic colorectal cancer?

Was your last treatment for metastatic colorectal cancer longer than one month ago? Note that your answer to this question will not disqualify you from participating in this study

Must not have

Have you ever received Irinotecan, (otherwise known as Camptosar and/or Onivyde) to treat your colorectal cancer?

Timeline

Screening 4 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called aplitibart with standard chemotherapy and another drug in patients with metastatic colorectal cancer that has come back or spread. The treatment works by killing cancer cells and cutting off their nutrient supply.

Who is the study for?

This trial is for adults with colorectal cancer that has returned or spread after treatment. Participants can have had prior treatments, must be able to perform light daily activities, and should not have been treated with irinotecan for their cancer.

What is being tested?

The study is examining the safety and effectiveness of aplitibart combined with FOLFIRI chemotherapy and bevacizumab in treating advanced colorectal cancer. It aims to find out if this new combination can help patients whose cancer has relapsed or spread.

What are the potential side effects?

Possible side effects include reactions related to aplitibart, such as infusion-related symptoms, fatigue, nausea from FOLFIRI chemotherapy, and increased risk of bleeding or hypertension due to bevacizumab.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Timeline

Screening ~ 4 weeks1 visit

Treatment ~ Varies

Follow Up ~ 36 months1 visit

Screening ~ 4 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 4 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel

Ph1a: To identify the recommended expansion dose for aplitabart as single agent, with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel

Ph1b: Progression-Free Survival (PFS)

Secondary study objectives

Ph1a and Ph1b: Area Under the Curve (AUC) of aplitabart

Ph1a and Ph1b: Clearance (CL) of aplitabart

Ph1a and Ph1b: Duration of Response (DoR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Ph1b: FOLFIRI + BevacizumabExperimental Treatment2 Interventions

Standard of Care FOLFIRI + bevacizumab will be administered intravenously

Group II: Ph1b: Aplitabart + FOLFIRI + BevacizumabExperimental Treatment3 Interventions

Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab

Group III: Ph1a: Aplitabart Single Agent Alternate Dosing EscalationExperimental Treatment1 Intervention

Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.

Group IV: Ph1a: Aplitabart + Venetoclax Escalation and ExpansionExperimental Treatment2 Interventions

Aplitabart will be administered intravenously in combination with Venetoclax.

Group V: Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and ExpansionExperimental Treatment3 Interventions

Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine.

Group VI: Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and ExpansionExperimental Treatment3 Interventions

Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.

Group VII: Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and ExpansionExperimental Treatment3 Interventions

Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine.

Group VIII: Ph1a: Aplitabart + Birinapant Escalation and ExpansionExperimental Treatment2 Interventions

Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2240

Docetaxel

1995

Completed Phase 4

~6550

Azacitidine

2012

Completed Phase 3

~1440

Birinapant

2013

Completed Phase 2

~230

Gemcitabine

2017

Completed Phase 3

~1920

FOLFIRI

2005

Completed Phase 3

~5860

0 / 5Eligibility 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

Common treatments for colorectal cancer include chemotherapy and targeted therapies. Chemotherapy regimens like FOLFIRI and FOLFOX disrupt DNA replication and cell division, leading to cancer cell death. Targeted therapies such as bevacizumab inhibit angiogenesis by targeting VEGF, reducing the tumor's blood supply, while cetuximab blocks EGFR, preventing cancer cell growth signals. These mechanisms are vital for colorectal cancer patients as they offer diverse strategies to combat cancer, potentially enhancing treatment effectiveness and patient survival.

Brazilian society of surgical oncology: Guidelines for the surgical treatment of mid-low rectal cancer.A Multidisciplinary Approach for the Personalised Non-Operative Management of Elderly and Frail Rectal Cancer Patients Unable to Undergo TME Surgery.Resection of hepatic metastases from colorectal cancer. Biologic perspective.