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Urothelial CarcinomaPhase 3NCT05302284

A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

A Phase 3 study testing RC48-ADC, Toripalimab and Gemcitabine in people with Urothelial Carcinoma and HER2-expressing, run by RemeGen Co., Ltd. at 2 sites 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
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Trial summary

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma, HER2-expressing
What is being tested?
RC48-ADC, Toripalimab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
2 sitesChina
Study dates
14 Jun 2022to 30 Apr 2028
Phase
Phase 3
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

  • Expected survival ≥12 weeks.
  • Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.
  • Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
  • Participants that received neoadjuvant chemotherapy with recurrence >6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence >6 months from completion of therapy are permitted.
  • At least one measurable lesion based on RECIST version 1.1
  • HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
  • ECOG performance status score: 0 or 1.
  • Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.

Who cannot join

  • Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
  • History of major surgery within 4 weeks of planned start of trial treatment.
  • Toxicity from a previous treatment has not returned to Grade 0-1.
  • Prior ADCs or PD-1/PD-L1 inhibitor therapy.
  • Active central nervous system (CNS) metastases.
  • Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
Show all 10Show fewer
  • History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
  • Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
  • Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

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

Jianmin Fang, PhD contact

+86-010-58075561

jianminfang@hotmail.com

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Aiping zhou

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Jun Guo

    Recruiting

Other trials in China

About this study

Official title: A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

Read the detailed description

This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in Combination With JS001,a PD-1 monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

Being tested
RC48-ADC, Toripalimab, Gemcitabine, Cisplatin, Carboplatin
Keywords
Urothelial Carcinoma, HER2-expressing, RC48, First-Line
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • RC48-ADCDrug

    Also called Disitamab Vedotin

    2.0 mg/kg IV every 2 weeks

  • ToripalimabDrug

    Also called JS001

    3.0 mg/kg IV every 2 weeks

  • GemcitabineDrug

    1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle

  • CisplatinDrug

    70mg/m2 IV infusion on Day 1 of every 3 week cycle

  • CarboplatinDrug

    AUC=4.5, IV infusion on Day 1 of every 3 week cycle

Study groups in NCT05302284
Study groupRoleWhat they receive
RC48-ADC + JS001ExperimentalParticipants will receive RC48-ADC + JS001 every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: RC48-ADC; Drug: Toripalimab
Gemcitabine + cisplatin/carboplatinActive comparatorParticipants will receive Gemcitabine + cisplatin or carboplatin every 3 weeks (Q3W) for maximum 6 weeks or until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin

What is being measured

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

  1. Progression-free survival (PFS), evaluated by independent review committee

    Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by independent review committee according to the RECIST 1.1 standard.

    Measured: Up to approximately 3 years

  2. Overall survival (OS)

    Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

    Measured: Up to approximately 3 years

Secondary outcomes (4)

  1. Objective remission rate (ORR)

    The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).

    Measured: Up to approximately 3 years

  2. Progression-free survival (PFS), evaluated by the investigator

    Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

    Measured: Up to approximately 3 years

  3. Duration of relief (DOR)

    DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

    Measured: Up to approximately 3 years

  4. Disease control rate (DCR)

    Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.

    Measured: Up to approximately 3 years

Timeline

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

  1. First posted31 Mar 2022
  2. Study start14 Jun 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Apr 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302284
Sponsor's protocol ID
RC48-C016
Status last verified
Dec 2023
First submitted
21 Mar 2022
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Dec 11;393(23):2324-2337. doi: 10.1056/NEJMoa2511648. Epub 2025 Oct 19.

    PubMed 41124210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC48-ADC, Toripalimab and Gemcitabine in people with Urothelial Carcinoma and HER2-expressing, run by RemeGen Co., Ltd. at 2 sites 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 8 inclusion and 10 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Jianmin Fang, PhD (+86-010-58075561, jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS), evaluated by independent review committee (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. 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 NCT05302284, which also lists 1 linked publication.

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 18 Dec 2023.

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