What side effects are associated with this type of intervention?

Common treatments for sarcoma, particularly those similar to investigational drugs like CBX-12 for advanced or metastatic refractory solid tumors, often include cytotoxic chemotherapy, molecularly targeted agents, and immunomodulatory drugs. The known side effects of these treatments can include gastrointestinal disorders (nausea, vomiting, diarrhea), hematologic toxicities (anemia, neutropenia, thrombocytopenia), fatigue, skin and subcutaneous tissue disorders (rash, pruritus), and cardiac disorders. Additionally, serious adverse events such as infections and sepsis can occur, necessitating close monitoring and supportive care.

What prior FDA approvals exist?

Several FDA-approved treatments for advanced or metastatic sarcomas include pazopanib, eribulin, and trabectedin. Pazopanib is a tyrosine kinase inhibitor that targets multiple receptors involved in tumor growth and angiogenesis. Eribulin, a microtubule dynamics inhibitor, is approved for patients with liposarcoma who have received prior chemotherapy. Trabectedin, an alkylating agent, is used for patients with liposarcoma or leiomyosarcoma who have previously been treated with anthracyclines. These treatments share a focus on targeting advanced or refractory sarcomas, similar to the investigational drug CBX-12.

What other types of research exist?

Promising novel alternatives to CBX-12 for sarcoma patients in 2024 include: 1) ATR inhibitors like M6620, which have shown exceptional responses in early-phase trials for various malignancies. 2) mTOR inhibitors such as temsirolimus, which have demonstrated durable clinical responses in refractory cases. 3) Targeted therapies like BTK inhibitors (ibrutinib, acalabrutinib) and BCL2 inhibitors (venetoclax) that have shown efficacy in other refractory cancers and may be applicable to sarcomas.

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CBX-12 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Cybrexa Therapeutics

Eligibility Criteria Checklist

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

Must have

Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.

An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called CBX-12 on patients with advanced tumors that haven't responded to other treatments. The goal is to find the safest and most effective dose by trying different schedules.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that have worsened after treatment, or when no approved therapy exists. Participants must have measurable disease and provide tumor samples. They can't join if they've had certain treatments within 3 weeks (2 weeks for some cases) before starting the study, are on other cancer treatments, have significant diseases, or active brain metastases without approval.

What is being tested?

CBX-12 is being tested in this Phase 1/2 trial to evaluate its safety and how it affects the body (pharmacokinetics). It's an open-label study where everyone gets CBX-12; there's a dose-escalation phase to find the right amount of drug that's safe and potentially effective.

What are the potential side effects?

Since CBX-12 is new and this is a first-in-human study, specific side effects aren't listed yet. Generally, such trials watch out for any signs of organ inflammation, allergic reactions to the drug infusion, fatigue, nausea or other digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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My advanced cancer has worsened after treatment, or no approved treatment exists for it.

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I have a recent tumor sample from a needle biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Phase 1: Incidence of treatment-emergent adverse events (TEAEs)

Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B)

Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B)

+2 more

Secondary study objectives

Apparent Volume of Distribution at Steady State (Vss) CBX-12

Area under the curve from 0-24 hours of CBX-12

Clearance (CL) of CBX-12

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2 Ovarian Cancer Expansion CohortExperimental Treatment1 Intervention

CBX-12 administered TBD

Group II: Phase 2 Metastatic Breast Expansion CohortExperimental Treatment1 Intervention

CBX-12 administered TBD

Group III: Phase 1 Schedule C Dose Escalation (Once Weekly Dosing )Experimental Treatment1 Intervention

CBX-12 administered once weekly, 4 week schedule

Group IV: Phase 1 Schedule B Dose Escalation (Daily Dosing x 3)Experimental Treatment1 Intervention

CBX-12 administered on a daily x 3, 3 week schedule

Group V: Phase 1 Schedule A Dose Escalation (Daily Dosing x 5)Experimental Treatment1 Intervention

CBX-12 administered on a daily x 5, 3 week schedule

Group VI: Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks)Experimental Treatment1 Intervention

CBX-12 administered once every 3 weeks

0 / 2Eligibility 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 sarcoma include chemotherapy, which damages the DNA of rapidly dividing cells to induce cell death, and targeted therapies like tyrosine kinase inhibitors that block specific molecules involved in tumor growth. Investigational drugs such as CBX-12 may target unique pathways or molecular markers specific to cancer cells. Understanding these mechanisms is essential for sarcoma patients as it aids in selecting the most effective treatment tailored to the tumor's characteristics, potentially improving outcomes and minimizing side effects.

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