AzTrials
AzTrials

NMIBCPhase 2NCT05943379

RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects

A Phase 2 study testing RC48-ADC in Combination with gemcitabine in people with NMIBC, run by RemeGen Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NMIBC
What is being tested?
RC48-ADC in Combination with gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteChina
Study dates
8 Jun 2023to 1 Dec 2026
Phase
Phase 2
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

  • 1. Voluntary consent to participate in the study and sign an informed consent form.
  • 2. Male or female, age ≥ 18 years. 3. Disease satisfies.
  • Diagnosis in accordance with the Chinese Guidelines for the Treatment of Bladder Cancer (2022) high-risk non-muscle invasive bladder cancer (NMIBC) and meeting any of the following ± carcinoma in situ (CIS): 1. stage T1 tumor of any grade; 2. high-grade tumor; 3. multiple and/or recurrent tumors, with recurrent tumors excluding low-grade solitary tumors.
  • Histopathological satisfaction of uroepithelial carcinoma predominant by histopathology, confirming the absence of muscular infiltration.
  • Completion of TURBT and resection of all visible lesions within 3 weeks prior to study dosing.
  • Clinical staging (cTa/T1±CIS, N0, M0) and absence of distant metastases as assessed by imaging (which needs to include at least CTU) within 3 months prior to enrollment.
Show all 21Show fewer
  • 4. 4. Prior BCG treatment.
  • Cohort 1 is high-risk NMIBC patients who have not received prior BCG therapy: high-risk NMIBC patients who have not received prior BCG therapy due to subjective and objective conditions, including one of the following 1. patient refusal to receive BCG therapy; 2. presence of contraindications to BCG therapy; 3. BCG inaccessibility.
  • Cohort 2 was high-risk NMIBC patients with BCG non-response, and BCG non-response met any of the following: 1. presence of persistent/recurrent high-risk NMIBC within 12 months (±1 month) of completing adequate BCG therapy; 2. high-grade T1 disease at first assessment after induction phase BCG therapy. Note: Adequate BCG therapy is defined as at least 5 BCG bladder instillations completed within 2 months and at least 2 BCG bladder instillations completed in any 6 consecutive weeks over the next 10 months, i.e., at least "5+2" BCG bladder instillations completed over an approximately 12-month period.
  • 5. Subjects who have been assessed by a urologist to be unsuitable for radical bladder cancer surgery or who have refused radical bladder cancer surgery.
  • 6. Subjects whose tumor tissue obtained by TURBT within 3 weeks meets 1+, 2+ or 3+ HER2 expression by immunohistochemistry (IHC) at the study center.
  • 7. ECOG physical status score of 0-2. 8. Adequate cardiac, bone marrow, liver, and renal function, which should meet the following criteria within 7 days prior to study dosing (normal values are based on the clinical trial center).
  • Left ventricular ejection fraction ≥ 50%.
  • Hemoglobin ≥ 9 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5×109/L.
  • Platelets ≥ 100×109/L.
  • Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
  • ALT and AST ≤ 2.5×ULN.
  • blood creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min calculated according to the Cockcroft-Gault formula method.
  • 9. Female subjects should be surgically sterilized, post-menopausal, or agree to use at least one medically approved contraceptive (e.g., IUD, pill, or condom) during study treatment and for 6 months after the end of the study treatment period, and must have a negative blood pregnancy test within 7 days prior to study enrollment; false-positive results may be excluded by the investigator after enrollment. Male subjects should agree to use at least one medically approved contraceptive during the study treatment period and for 6 months after the end of the study treatment period.
  • 10. be willing and able to comply with the trial and follow-up procedural arrangements.

Who cannot join

  • muscle-invasive bladder cancer (T2 and above) and/or with regional lymph nodes and distant metastases
  • Combined extra-vesical (i.e. urethral, ureteral or renal pelvis) uroepithelial carcinoma.
  • Received any other antitumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 dose of infusion chemotherapy completed immediately after TURBT.
  • Have not recovered from an adverse event caused by a previously applied antineoplastic agent to CECAT 5.0 grade 0-1 within 2 weeks prior to the start of study dosing.
  • Those who have undergone major surgery within 4 weeks prior to the start of study dosing or who are scheduled to undergo major surgery during the trial.
  • Serum virological tests (based on the normal values of the study center).
Show all 26Show fewer
  • Positive HBsAg or HBcAb test result with a positive HBVDNA copy number.
  • Positive HCVAb test result together with a positive HCVRNA test result.
  • Positive HIVAb test result.
  • live vaccine received within 4 weeks prior to the start of study dosing or scheduled to receive any vaccine (except novel coronavirus vaccine) during the study period.
  • heart failure classified as grade 3 or higher by the New York Heart Association (NYHA) of America.
  • the presence of a serious arterial/venous thrombotic event or cardiovascular accident such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, or myocardial infarction within 6 months prior to study dosing, except for lacunar cerebral infarction that is asymptomatic and does not require clinical intervention
  • the presence of an active infection requiring systemic treatment, such as active tuberculosis
  • the presence of active, unstably controlled systemic disease or serious comorbidity as judged by the investigator, including diabetes mellitus, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, complications that could cause the subject to undergo intravesical therapy and/or general anesthesia
  • having any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study drug or that will affect the interpretation of the study results, or that places the patient at high risk
  • the presence of an active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressants) prior to the start of study dosing, allowing for associated replacement therapy (e.g., thyroxine for adrenal or pituitary insufficiency, or replacement therapy with physiologic corticosteroids)
  • other malignancies within 5 years prior to the start of study dosing, with the following exceptions.
  • Malignancies that can be expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or radical surgically treated ductal carcinoma in situ of the breast).
  • Patients with prostate cancer with prior specific treatment (surgery or radiation therapy).
  • T2N0M0 or earlier stage.
  • Gleason score ≤ 7 and prostate-specific antigen (PSA) undetectable for at least 1 year after anti-androgen therapy.
  • Patients with viable specific therapy or on active surveillance without specific therapy, with stable disease 1 year prior to study entry.
  • previous history of allogeneic HSCT or organ transplantation
  • known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent drug and its components or hypersensitivity to gemcitabine and any excipients
  • women who are pregnant or breastfeeding.
  • estimated insufficient patient compliance to participate in this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Peking University First Hosptital

    Beijing, Beijing Municipality, 100034

    Zhisong He, Doctor, 13910688432, wyj7074@sohu.com

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Single Arm, Single Center Phase 2 Study of RC48-ADC (IV) in Combination With Gemcitabine(Intravesical) in High Risk NMIBC Subjects (BCG Naïve or BCG Unresponsive) That Expresses HER2 (IHC 1+ and Greater)

In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.

Read the detailed description

The study will be comprised of 2 cohorts. The cohort 1 is BCG Naïve and cohor 2 is BCG Unresponsive.

All participants will receive RC48-ADC(IV) in combination with gemcitabine(intravesical). Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.

Conditions
NMIBC
Being tested
RC48-ADC in Combination with gemcitabine
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.

  • RC48-ADC in Combination with gemcitabineDrug

    RC48-ADC IV (intravenous) 2.0mg/kg IV, Q2W, 8W; Q4W, 40W Gemcitabine Intravesical 1000mg induction QW,8W; maintenance Q4W,40W

Study groups in NCT05943379
Study groupRoleWhat they receive
cohort 1ExperimentalBCG Naïve
Receives: Drug: RC48-ADC in Combination with gemcitabine
cohort 2ExperimentalBCG Unresponsive
Receives: Drug: RC48-ADC in Combination with gemcitabine

What is being measured

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

  1. 12-month Disease Free Survival Rate

    Measured: 12 month

Secondary outcomes (7)

  1. Complete Response Rate

    Measured: 3 month

  2. 6-month Disease Free Survival Rate

    Measured: 6 month

  3. 18-month Disease Free Survival Rate

    Measured: 18 month

  4. 24-month Disease Free Survival Rate

    Measured: 24 month

  5. Recurrence-free survival

    Measured: up to 24 months

  6. Progression-Free Survival

    Measured: up to 24 months

  7. Overall Survival

    Measured: up to 5 years

Timeline

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

  1. First posted13 Jul 2023
  2. Study start8 Jun 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943379
Sponsor's protocol ID
RC48-C028
Status last verified
May 2023
First submitted
13 Mar 2023
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48-ADC in Combination with gemcitabine in people with NMIBC, run by RemeGen Co., Ltd. at 1 site in China.

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 21 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 13 Jul 2023. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month Disease Free Survival Rate (time frame: 12 month). 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 NCT05943379.

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 13 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in