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Anti-tumor antibiotic

PEN-866 + Chemotherapy for Sarcoma

Phase 1 & 2

Waitlist Available

Led By Christine M Heske, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

For phase 2, participants must have histologically or cytologically confirmed recurrent or refractory Ewing sarcoma (Cohort 2) or embryonal or alveolar rhabdomyosarcoma (Cohort 3). Participants with Ewing sarcoma (Cohort 2 only) should have evidence of EWS translocation by FISH or RT-PCR.

Phase 2: Histologically or cytologically confirmed recurrent or refractory Ewing sarcoma (Cohort 2) or embryonal or alveolar rhabdomyosarcoma (Cohort 3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre/post infusion on cycle 1 day 1, 24 hr post infusion, cycle 1 day 4, cycle 1 day 8. cycle 3 day 1 and cycle 3 day 8

Awards & highlights

Study Summary

This trial is studying the combination of 3 drugs to see if it can be used to treat adolescents and young adults with solid tumors, Ewing sarcoma, or rhabdomyosarcoma that returned after or did not respond to standard treatments.

Who is the study for?

Adolescents and young adults aged 12-39 with solid tumors, Ewing sarcoma, or rhabdomyosarcoma that have not responded to standard treatments are eligible. They must have adequate organ function, no severe prior treatment toxicity unresolved, and agree to use contraception if applicable. Those with certain genetic conditions or on prohibited medications cannot join.Check my eligibility

What is being tested?

The trial tests a combination of PEN-866 with vincristine and temozolomide in patients who've had relapsed or refractory solid tumors. Over up to 18 cycles (21 days each), participants receive these drugs intravenously and orally while their health is monitored through exams, questionnaires, and lifelong follow-ups.See study design

What are the potential side effects?

Potential side effects include reactions related to the infusion process, possible organ inflammation due to drug interactions, fatigue from treatment regimens, digestive issues from oral medication intake as well as blood disorders stemming from the chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

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

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I have confirmed recurrent or refractory Ewing sarcoma or rhabdomyosarcoma.

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I have a confirmed diagnosis of Ewing sarcoma or rhabdomyosarcoma that has come back or did not respond to treatment.

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I have a confirmed solid tumor that has come back or didn't respond to treatment, but it's not in my brain or lymph nodes.

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I can take care of myself but might not be able to do any heavy work.

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I have had treatment for brain metastases.

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It's been over 3 weeks since my last chemotherapy that affects my bone marrow.

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I have a confirmed solid tumor that has come back or did not respond to treatment, excluding brain tumors and lymphoma.

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I am between 12 and 39 years old.

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My cancer can be seen on scans or confirmed through tests.

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I am willing to have a central line placed if I don't already have one.

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I have new or worsening brain metastases or leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of progression or death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of progression or death

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression or death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Maximum tolerated/recommended phase 2 dose

Phase 2: Objective response rate

Secondary outcome measures

Phase 1: Plasma and tumor pharmacokinetics

Phase 1: Toxicity

Phase 2: Duration of response

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/MTD/RP2DExperimental Treatment3 Interventions

PEN-866 at the MTD or RP2D from phase 1 plus vincristine and temozolomide

Group II: 1/Dose EscalationExperimental Treatment3 Interventions

Dose escalation of PEN-866 along with fixed doses of vincristine and temozolomide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine

2003

Completed Phase 4

~2910

Temozolomide

2010

Completed Phase 3

~1930

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,717 Previous Clinical Trials

40,953,299 Total Patients Enrolled

87 Trials studying Rhabdomyosarcoma

11,781 Patients Enrolled for Rhabdomyosarcoma

Christine M Heske, M.D.Principal InvestigatorNational Cancer Institute (NCI)

1 Previous Clinical Trials

14 Total Patients Enrolled

1 Trials studying Rhabdomyosarcoma

14 Patients Enrolled for Rhabdomyosarcoma

Media Library

PEN-866 (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04890093 — Phase 1 & 2

Rhabdomyosarcoma Research Study Groups: 1/Dose Escalation, 2/MTD/RP2D

Rhabdomyosarcoma Clinical Trial 2023: PEN-866 Highlights & Side Effects. Trial Name: NCT04890093 — Phase 1 & 2

PEN-866 (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04890093 — Phase 1 & 2

~43 spots leftby Feb 2026

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