What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, especially those involving targeted therapies like monoclonal antibodies (e.g., cetuximab), often result in side effects such as acne-like rash, diarrhea, mucositis, and infusion-related reactions. Chemotherapy regimens, such as those including oxaliplatin and fluorouracil, can cause additional side effects like peripheral neuropathy, nausea, vomiting, and hematologic toxicities (e.g., neutropenia). These side effects vary in severity and frequency but are important considerations in the management of colorectal cancer.

What prior FDA approvals exist?

FDA-approved treatments for colorectal cancer include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. Notably, cetuximab and panitumumab are monoclonal antibodies targeting the epidermal growth factor receptor (EGFR), used in patients with wild-type RAS tumors. Additionally, regorafenib and trifluridine/tipiracil are approved for metastatic colorectal cancer. While these treatments do not specifically target DR5, they represent the broader category of targeted therapies aimed at specific molecular pathways in cancer cells.

What other types of research exist?

Promising novel alternatives to INBRX-109 for colorectal cancer patients in 2024 include: 1) Immunotherapies such as pembrolizumab (anti-PD-1) and nivolumab (anti-PD-1), which have shown efficacy in microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancers. 2) Targeted therapies like encorafenib (BRAF inhibitor) combined with cetuximab (EGFR inhibitor) for BRAF V600E-mutant colorectal cancer. 3) Novel agents such as trastuzumab deruxtecan (HER2-targeted antibody-drug conjugate) for HER2-positive colorectal cancer. 4) Emerging therapies like bispecific T-cell engagers (BiTEs) and chimeric antigen receptor (CAR) T-cell therapies targeting specific tumor antigens.

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Monoclonal Antibodies

INBRX-109 for Solid Tumors

Verified Trial

Phase 1

Recruiting

Research Sponsored by Inhibrx, Inc.

Eligibility Criteria Checklist

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

Must have

Are you taking medication for your depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests INBRX-109, a protein that attaches to harmful cells and signals the body to destroy them. It targets patients with conditions involving DR5, like certain cancers.

Who is the study for?

This trial is for adults with advanced or inoperable solid tumors, including various sarcomas and specific cancers like mesothelioma and pancreatic adenocarcinoma. Participants must have tried standard treatments without success or have no beneficial standard options available. They should be physically able to perform daily activities (with some limitations) and have their major organs functioning well. People with recent severe liver disease, infections needing antibiotics, prior DR5 agonist exposure, other cancer treatments within the last month, certain heart conditions, or known sensitivity to the study drugs cannot join.

What is being tested?

The trial is testing INBRX-109, a new antibody targeting death receptor 5 on cancer cells. It's given alongside existing chemotherapy drugs: carboplatin, cisplatin, pemetrexed, fluorouracil (5-FU), irinotecan, and temozolomide. The study has three parts but isn't randomizing patients; instead it progressively includes more participants as safety data emerges.

What are the potential side effects?

Possible side effects of INBRX-109 may include reactions at the infusion site and symptoms related to immune activation such as fever or fatigue. Chemotherapy can cause nausea/vomiting, hair loss, blood cell count changes leading to increased infection risk or bleeding problems; kidney/liver function changes; nerve damage causing numbness/tingling.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

Evaluating Tumor Response for colorectal cancers and Ewing sarcoma

Frequency and severity of adverse events of INBRX-109

Secondary study objectives

Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies.

Immunogenicity of INBRX-109

Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma.

Other study objectives

Anti-tumor activity of INBRX-109

Potential predictive response biomarkers

Awards & Highlights

No Placebo-Only Group

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

Trial Design

11Treatment groups

Experimental Treatment

Group I: Expansion Solid Tumors (Complete)Experimental Treatment1 Intervention

Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group II: Expansion Sarcomas (Complete)Experimental Treatment1 Intervention

Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group III: Expansion Malignant Pleural Mesothelioma (Complete)Experimental Treatment1 Intervention

Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group IV: Expansion Gastric Adenocarcinoma (Complete)Experimental Treatment1 Intervention

Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group V: Expansion Colorectal Adenocarcinoma (Complete)Experimental Treatment1 Intervention

Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Group VI: Dose Escalation (Complete)Experimental Treatment1 Intervention

INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

Group VII: Combination Expansion SDH-deficient solid tumors or GIST (Complete)Experimental Treatment2 Interventions

Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide

Group VIII: Combination Expansion Pancreatic Adenocarcinoma (Complete)Experimental Treatment3 Interventions

Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy

Group IX: Combination Expansion Malignant Pleural Mesothelioma (Complete)Experimental Treatment4 Interventions

Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)

Group X: Combination Expansion Ewing SarcomaExperimental Treatment3 Interventions

Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

Group XI: Combination Expansion Colorectal AdenocarcinomaExperimental Treatment3 Interventions

Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Cisplatin

2013

Completed Phase 3

~3120

5-fluorouracil

2005

Completed Phase 4

~8440

Irinotecan

2017

Completed Phase 3

~2590

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

0 / 1Eligibility 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, targeted therapy, and immunotherapy. Chemotherapy drugs like fluoropyrimidines and oxaliplatin work by interfering with DNA replication and cell division, leading to cancer cell death. Targeted therapies, such as cetuximab, inhibit specific molecules involved in tumor growth, like the epidermal growth factor receptor (EGFR). Immunotherapies, including anti-PD-1 antibodies, enhance the immune system's ability to recognize and destroy cancer cells. INBRX-109, a recombinant humanized tetravalent antibody targeting DR5, induces apoptosis by activating death receptors on cancer cells. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and minimizing side effects.

Anti-colorectal cancer targets of resveratrol and biological molecular mechanism: Analyses of network pharmacology, human and experimental data.