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A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

PHASE1TERMINATED

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.

Study details:

CF33-hNIS, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with pembrolizumab or mFOLFOX to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment. Patients eligible for treatment in dose escalation IT/IV cohorts include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy which may have included treatment with an Immune Checkpoint Inhibitor(ICI). For expansion IT and IV cholangiocarcinoma cohort patients, one prior line of systemic chemotherapy in metastatic/advanced setting is required and for patients with targetable tumor mutations, must have also received 1 line of an approved targeted therapy.

For expansion IV cholangiocarcinoma cohort, prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted. For IT/IV cohorts, patients will be treated with CF33-hNIS on Day 1 and 8 of Cycle 1 and then on Day 1 of each cycle thereafter. Patients treated with the combination regimen with pembrolizumab will also receive pembrolizumab Day 1 of each cycle beginning with Cycle 2.

For IV cholangiocarcinoma expansion cohort, patients will be treated with CF33-hNIS on Day 3 and Day 17 of each 28 day cycle along with a modified FOLFOX regimen.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Written informed consent from patient or legally authorized representative
  2. Age ≥ 18 years old on the date of consent
  3. IT/IV cohorts: Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor (ICI) treatment). Expansion cholangiocarcinoma IT and IV cohorts: one prior line of chemotherapy in metastatic/advanced setting. Patients with targetable tumor mutations must have also received 1 line of approved targeted therapy.
  4. Expansion cholangiocarcinoma IV cohort: prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted.
  5. ECOG performance status 0 - 2
  6. At least one measurable lesion
  7. For IT administration, ideally < 5 total lesions no greater than 10cm and <33% of liver volume replaced by tumor.
  8. Adequate renal function
  9. Adequate liver function
  10. Adequate hematologic function
  11. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

  1. Prior treatment with a poxvirus based oncolytic virus.
  2. Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
  3. Prior radiotherapy within 2 weeks of start of study treatment.
  4. Active autoimmune disease
  5. Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state
  6. Inadequate pulmonary function per Investigator assessment.
  7. Uncontrolled brain or other central nervous system (CNS) metastases.
  8. History of documented congestive heart failure (New York Heart Association [NYHA] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT05346484

Intervention or treatment

BIOLOGICAL: CF33-hNIS

BIOLOGICAL: Pembrolizumab

DRUG: Modified FOLFOX

Conditions

  • Solid Tumor
  • Solid Carcinoma
  • Solid Tumor, Adult
  • Metastatic Cancer
  • Advanced Solid Tumor
  • Cholangiocarcinoma
  • Bile Duct Cancer

  • Condition: Solid Tumor, Solid Carcinoma and more

  • BIOLOGICAL: CF33-hNIS and other drugs

  • Southport, Queensland, Australia and more

  • Sponsor: Imugene Limited

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Tasman Oncology Research

Select from list below to view details:

  • Tasman Oncology Research

    Southport, Queensland, Australia

  • St. Vincent's Hospital

    Fitzroy, Victoria, Australia

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Who is running the clinical trial?

IL

Imugene Limited

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: CF33-hNIS IT Administration Monotherapy
  • Not Specified
Biological: CF33-hNIS
    EXPERIMENTAL: CF33-hNIS IV Administration Monotherapy
    • Not Specified
    Biological: CF33-hNIS
      EXPERIMENTAL: CF33-hNIS IT Administration in Combination with Pembrolizumab
      • Not Specified
      Biological: CF33-hNIS, Biological: Pembrolizumab
        EXPERIMENTAL: CF33-hNIS IV Administration in Combination with Pembrolizumab
        • Not Specified
        Biological: CF33-hNIS, Biological: Pembrolizumab
          EXPERIMENTAL: CF33-hNIS IV Administration in Combination with modified FOLFOX
          • Not Specified
          Biological: CF33-hNIS, Drug: Modified FOLFOX

            What is the study measuring?

            Primary Outcome

            MeasureDescriptionTime Frame
            Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumabAdverse events will be graded according to CTCAE v5.0.From first dose of study drug through 30 days following the last dose of study treatment.
            Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumabRP2D determination will be based on evaluation of Dose Limiting Toxicities (DLT) as well as other safety, efficacy and correlative data.From first dose of study drug through 21-42 days following the first dose of study treatment.

            Secondary Outcome

            MeasureDescriptionTime Frame
            Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOXORR is defined as the proportion of patients in the efficacy population who achieve a radiographic Investigator-assessed confirmed complete response (CR) or partial response (PR), per RECIST v1.1 or confirmed immune complete response (iCR) or immune partial response (iPR) per iRECIST v1.0.Up to 2 years from first dose of study drug.
            Progression-free survival (PFS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOXPFS, defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first.Up to 2 years from first dose of study drug.
            Overall survival (OS) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOXdefined as the time from the start of treatment until death due to any cause. Median OS and OS rate at 12 months will be reported.Up to 2 years from first dose of study drug.
            Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOXDOR is defined as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause.Up to 2 years from first dose of study drug.
            Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab or modified FOLFOXDCR is defined as the proportion of patients who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0.Up to 2 years from first dose of study drug.
            To evaluate viral titers of CF33-hNISViral Plaque Assay (VPA) and polymerase chain reaction (PCR) testing from serum, urine, oral swab, rectal swab, injection site(s) swab and wound dressing swab.Up to 2 years from first dose of study drug.
            To evaluate infection of tumors with CF33-hNIShNIS-based imaging via SPECT technetium-99 (99TC).21 days from first dose of study drug
            Are you running this trial?If you're a clinic or sponsor, you can claim this study.
            Claim this trial

            References

            Clinical Trials Gov: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

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