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Non-muscle Invasive Bladder CancerPhase 1NCT06253845

Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

A Phase 1 study testing CG0070 in people with Non-muscle Invasive Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle Invasive Bladder Cancer
What is being tested?
CG0070
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have pathologically confirmed:
  • Recurrent Low-grade Ta
  • Solitary Low-Grade Ta > 3cm
  • Low-grade Ta multifocal
  • High-grade Ta ≤ 3cm
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  • Have all visible disease except a single "marker lesion" of approximately 0.3 - 1 cm diameter removed at baseline prior to initial CG0070 treatment (photographic documentation of lesion location and size must be conducted). "Marker lesion" must be clearly identifiable and assessable in the judgment of the investigator. "Marker lesion" location and size must be documented by the investigator (e.g., via photography).
  • Demonstrate adequate organ function, defined as:
  • Aspartate transaminase (AST), alanine aminotransferase (ALT)
  • ≤2.5 × upper limit of normal (ULN)
  • Total serum bilirubin ≤1.5 × ULN (OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN)
  • Absolute neutrophil count (ANC) ≥1,000 cells/mm3
  • Hemoglobin ≥8 g/dL or ≥4.96 mmol/L
  • Platelet count ≥100,000 platelets/mm3
  • Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min for patient with creatinine levels >1.5 institutional ULN according to Cockcroft-Gault formula
  • Serum chemistries: Sodium, potassium, and calcium within normal limits (WNL) or Grade 1
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN unless receiving anticoagulation therapy and INR or PT is within the therapeutic range of intended use of anticoagulants. (NOTE: patients must be able to suspend, based on local practice, anticoagulant and anti-platelet therapy for study specific biopsies and procedures)
  • Willing to use barrier contraception, as outlined in Section 6.6, during sexual activity, starting with Day 1 for up to 6 weeks after each dose of CG0070.
  • Patients must be willing to comply with study mandated cystoscopies, urine cytology, CT urograms, biopsies, and other procedures (including transurethral resection of bladder tumor [TURBT] or other resection for all visible disease). Patients who withdraw consent for these procedures will be withdrawn from the trial.

Who cannot join

  • Current or prior evidence of high-risk NMIBC defined as:
  • HG T1
  • Any recurrent HG (G3) Ta
  • HG Ta > 3 cm (or multifocal)
  • Any CIS
  • Any BCG exposure in HG patient
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  • Any variant histology
  • Any LVI
  • Any HG prostatic urethral involvement
  • Disease that is unable to be completely resected
  • Lack of marker lesion
  • Low-risk NMIBC defined as:
  • Low grade solitary Ta less than or equal to 3cm
  • Papillary urothelial neoplasm of low malignant potential
  • Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer
  • Has history of high grade or low grade urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems, ureters) or prostatic urethra (including CIS of the urethra) within 12 months of enrollment
  • Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1 NOTE: For participants who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent
  • Has any of the following within 6 months prior to starting study treatment: untreated myocardial infarction, untreated severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure that is deemed to be preventative from the patient completing study intervention and/or assessment.
  • Has used excluded anti-viral medication (e.g., interferon/peg-interferon, ribavirin, etc.) within 14 days of Day 1 and that cannot be suspended throughout for at least 14 days prior to and after each treatment with CG0070. Please consult with sponsor to discuss any anti-viral that cannot be discontinued.
  • Has had prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin/Instiladrin/nadofaragene firadenovec)
  • Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies and other procedures as per standard of care
  • Has significant immunodeficiency due to underlying illness (e.g., known HIV/AIDS). Note that HIV testing is not mandatory unless required by local health authorities.
  • Has received systemic immunosuppressive medication including high-dose corticosteroids (e.g. systemic corticosteroids >10 mg prednisone or equivalent) within 28 days prior to Day 1. NOTE: Patients must not be receiving doses of >10 mg/day of prednisone or equivalent at the time of study entry or during the study and corticosteroids may not be used for premedication
  • Has had an allogeneic tissue/solid organ transplant
  • Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
  • Has a known additional malignancy that, in the opinion of the treating physician, may interfere with the study conduct or require on study treatment for the malignancy
  • Has an active infection requiring systemic therapy (e.g., urinary tract infection or other active infection)
  • Has received a live replication competent vaccine within 30 days prior to the first dose of study drug.
  • Has not recovered (i.e., to ≤Grade 1 or to Baseline status) from AEs due to a previously administered agent or therapy
  • Has an illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate study treatment or that would limit compliance with study requirements
  • Is pregnant, currently breastfeeding or intending to breastfeed, within the projected duration of the trial beginning at Screening through 6 weeks after the last study treatment.
  • IVE therapy within 8 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g., Mitomycin C, gemcitabine, doxorubicin, and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted up to 14 to 60 days prior to beginning study treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1b, Single Arm Study of CG0070 After Transurethral Resection in Patients With Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

Being tested
CG0070
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CG0070Biological

    CG0070 will be administered at a dose of 1x10^12 vp intravesically following a sequence of bladder washes with DDM and normal saline.

Study groups in NCT06253845
Study groupRoleWhat they receive
CG0070ExperimentalCG0070 is a conditionally replicating oncolytic adenovirus (serotype 5) designed to preferentially replicate in and kill cancer cells.
Receives: Biological: CG0070

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. Complete Response Rate (CR)

    CR as defined by the response assessment.

    Measured: 12 weeks

  2. 12-month recurrence free survival rate (RFS)

    RFS is defined as the time from surgical removal of residual lesions after CG0070 treatment to recurrence of low- or high-grade urothelial carcinoma within the bladder.

    Measured: 12 months

  3. 24-month recurrence free survival rate (RFS)

    RFS is defined as the time from surgical removal of residual lesions after CG0070 treatment to recurrence of low- or high-grade urothelial carcinoma within the bladder.

    Measured: 24 months

  4. Progression free survival (PFS)

    PFS is defined as the time from documentation of Complete Response (CR) following CG0070 treatment to recurrence of low- or high-grade urothelial carcinoma within the bladder.

    Measured: Up to 24 months

  5. Cystectomy free survival (CFS)

    CFS is defined as the time from study registration to cystectomy performed for any cause. Reason for cystectomy will be collected and analyzed in conjunction with this endpoint.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start1 Mar 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253845
Sponsor's protocol ID
MCC-21690
Status last verified
Jun 2026
First submitted
2 Feb 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CG0070 in people with Non-muscle Invasive Bladder Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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