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Anti-tumor antibiotic

PEN-866 + Chemotherapy for Sarcoma

Phase 1 & 2
Recruiting
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)
Must not have
Requirement of medication with any of the inhibitors of UGT1A1, substrates of CYP1A2 or substrates of the P-gp, BCRP, OATP1B1, OATP1B3, or OCT1 transporters, or any prohibited medications
Known bone marrow metastatic disease causing decreased blood counts below the hematologic parameters for phase 1
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
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that interfere with specific body enzymes or transporters.
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My cancer has spread to my bone marrow, affecting my blood counts.
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I have not had major surgery in the last 28 days.
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I stopped taking vincristine, temozolomide, or irinotecan due to severe side effects.
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I have had severe nerve damage or constipation from vincristine.
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I do not have any unmanaged ongoing illnesses.
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My genetic test shows I have the UGT1A1 28/28 genotype.
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I am not currently taking any experimental drugs or other cancer treatments.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Maximum tolerated/recommended phase 2 dose
Phase 2: Objective response rate
Secondary study objectives
Phase 1: Plasma and tumor pharmacokinetics
Phase 1: Toxicity
Phase 2: Duration of response
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2970
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,965 Total Patients Enrolled
88 Trials studying Rhabdomyosarcoma
13,126 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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