What side effects are associated with this type of intervention?

Common treatments for Leiomyosarcoma (LMS) include doxorubicin, ifosfamide, and pazopanib. Doxorubicin can cause myelosuppression, alopecia, mucosal inflammation, and cardiotoxicity. Ifosfamide is associated with myelosuppression, neurotoxicity, and hemorrhagic cystitis. Pazopanib, a multikinase angiogenesis inhibitor, has side effects such as hypertension, hypothyroidism, diarrhea, and hepatotoxicity. These side effects should be carefully considered when selecting a treatment plan.

What prior FDA approvals exist?

The FDA has approved several anti-cancer agents for the treatment of Leiomyosarcoma (LMS). Pazopanib, an oral multikinase inhibitor, is approved for metastatic soft tissue sarcomas, including LMS, after progression on anthracycline-based therapy. Additionally, trabectedin has shown superiority over dacarbazine in patients with LMS who have previously received anthracycline-based therapy. Eribulin, a microtubulin inhibitor, is another option for patients who have failed prior anthracycline therapy. These treatments are relevant as they target similar pathways and mechanisms as the investigational drug OR2805, which is being studied for its anti-tumor activity in advanced solid tumors.

What other types of research exist?

Promising novel alternatives to OR2805 for Leiomyosarcoma patients include: 1) BO-1055, a DNA cross-linking agent with potent activity in sarcoma models and low toxicity. 2) Pazopanib, a multikinase angiogenesis inhibitor, which has shown efficacy in various advanced soft tissue sarcomas. 3) Trabectedin, which has demonstrated efficacy in myxoid liposarcomas and other soft tissue sarcomas.

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Monoclonal Antibody

OR2805 Monoclonal Antibody for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by OncoResponse, Inc.

Eligibility Criteria Checklist

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

Must have

Male or female subjects ≥ 18 and ≤ 100 years of age

Be older than 18 years old

Must not have

For Part B: Known contraindication to receiving cemiplimab. Interstitial lung disease. Prior pneumonitis requiring systemic corticosteroid therapy. Receiving immunosuppressive therapy, with exceptions as noted in exclusion criterion 10. A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any grade 4 toxicity or grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for more than 12 weeks. Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed provided the subject has undergone potentially curative therapy with no evidence of disease for at least 3 years. History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders. Subjects who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse. Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study

Subjects with symptomatic ascites or pleural effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of dosing through every 90 after the last dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests OR2805, an antibody targeting the CD163 protein, in patients with advanced cancers like melanoma and NSCLC. The treatment aims to help the immune system attack cancer cells by binding to CD163. The use of antibodies for targeting CD163+ macrophages in inflammation and cancer has shown high efficacy in animal models.

Who is the study for?

Adults aged 18-100 with various advanced cancers, including carcinoma, sarcoma, melanoma, and specific types like NSCLC. Participants must have finished previous cancer treatments at specified times before joining, be willing to use effective birth control if necessary, and have tumors measurable by RECIST v1.1 standards. They should not have certain medical conditions or be on conflicting medications.

What is being tested?

The trial is testing OR2805 alone and combined with Cemiplimab or Docetaxel in patients with advanced solid tumors. It's an early-phase study assessing safety, tolerability, how the body processes the drugs (pharmacokinetics), their effects on the body (pharmacodynamics), and initial effectiveness against tumors.

What are the potential side effects?

Potential side effects may include typical reactions to monoclonal antibodies such as infusion-related reactions; immune system complications that could affect organs; fatigue; allergic responses; plus any known side effects of Cemiplimab or Docetaxel like hair loss from chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 100 years old.

Exclusion Criteria

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

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I have fluid buildup in my abdomen or around my lungs that causes symptoms.

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I need help with my daily activities due to my health condition.

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I have had an organ or stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of dosing through every 90 after the last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of dosing through every 90 after the last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dosing through every 90 after the last dose. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-limiting Toxicity

Recommended Dose and Regimen (mono and combination therapy)

Safety and Tolerability

Secondary study objectives

Disease Control Rate (DCR)

Objective Response Rate (ORR)

Pharmacokinetics of OR2805

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: OR2805 monotherapy and combination therapy dose-expansion phase (Part B)Experimental Treatment3 Interventions

OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy or in combination with cemiplimab or docetaxel in subjects with NSCLC and melanoma. Cemiplimab will be administered as an IV infusion at a dose of 350 mg. Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.

Group II: OR2805 monotherapy and combination therapy dose-escalation phase (Part A)Experimental Treatment3 Interventions

Escalating repeated doses of OR2805 by IV administration as monotherapy or in combination with cemiplimab or docetaxel in subjects with advanced solid tumors. OR2805 will be administered once every 3 weeks (Q3W) or once-weekly (QW) for 3 weeks as an IV infusion over 30 minutes. Cemiplimab will be administered as an IV infusion at a dose of 350 mg. Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.

Group III: OR2805 biological effects phase (Part C)Experimental Treatment1 Intervention

OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyosarcoma, or SCCHN or are not otherwise eligible for Cohort B.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Docetaxel

1995

Completed Phase 4

~6550

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

Leiomyosarcoma (LMS) is commonly treated with doxorubicin, which intercalates DNA and inhibits topoisomerase II, leading to DNA damage and apoptosis. Dacarbazine works as an alkylating agent, causing DNA cross-linking and cell death. Eribulin inhibits microtubule dynamics, preventing cell division, while gemcitabine incorporates into DNA, causing chain termination. Combination therapies, such as doxorubicin with dacarbazine, aim to enhance efficacy through multiple mechanisms. Understanding these mechanisms helps LMS patients and their doctors choose treatments that target cancer cells effectively while managing side effects.

An assessment of the relative importance of the components of CYVADIC in the treatment of soft-tissue sarcomas using regression meta-analysis.PI3K/AKT/mTOR inhibition in combination with doxorubicin is an effective therapy for leiomyosarcoma.Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study.