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Urothelial CarcinomaPhase 1/2NCT04264936

A Study of RC48-ADC(Antibody Drug Conjugate) and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer

A Phase 1/2 study testing RC48-ADC and JS001 in people with Urothelial Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, single-arm, Phase Ib/II investigator-initiated trial of RC48-ADC combined with JS001 to evaluate the safety and pharmacokinetics of subjects with locally advanced or metastatic urothelial cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
RC48-ADC and JS001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
15 Feb 2020to 31 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Signed informed consent form; Aged 18 years and above; ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1; Life expectancy greater than 12 weeks; Patients with locally advanced or metastatic malignant urothelial carcinoma which is platinum naive and cisplatin ineligible, or progressed after at least one line standard systemic chemotherapy (including progression within 12 months of neo-/adjuvant therapy);
  • Cisplatinum ineligible patients should meet one of the following criteria:
  • Aged 70 years and above, and ECOG performance is 1;
  • Serum creatinine >= 1.0xULN or CrCl<60ml/min;
  • Lose of hearing >= Grade 2;
  • Peripheral nerve disorder >= Grade 2 Patients with measurable and appreciable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1); Willing to provide primary lesion samples for the purpose of PD-L1 and HER2 tests.
Show all 13Show fewer
  • Adequate organ function as defined by the following criteria:
  • absolute neutrophil count(ANC) >= 1.5 x 10^9/L;
  • platelets>=100* 10^9/L;
  • Total serum creatinine <=1.5*ULN;
  • serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <=2.5*upper limit of normal (ULN), or AST and ALT<=5*ULN if liver function abnormalities are due to underlying malignancy; normal serum creatinine ;
  • Left ventricular ejection fraction (LVEF) >=50%
  • Hemoglobin>=9g/dl Women of child-bearing potential and men must agree to use adequate contraception (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) prior to study entry and during the period of therapy and for 30 days after the last dose of study drug;

Who cannot join

  • Allergy to RC48-ADC, or JS001, or their components Received anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy or other clinical trial treatments within 3 weeks of starting study treatment Unresolved toxicities from prior anti-cancer therapy, except for alopecia Previously treated with HER2-ADC and/or anti-PD-1 or anti-PD-L1 or anti PD-L2 therapies; Underwent major surgery within 4 weeks of first dose of study drug and not completely recovered; Received vaccine within 4 weeks of first dose of study drug Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; History of other neoplastic disease within 3 years prior to the study drug, with exception of resolved/curable cancers such as basal skin cancer or squamous cell skin cancer,.
  • Metastasis to CNS(central nervous system) and/or carcinomatous meningitis, with exception for the patients who received treatment of metastasis to CNS and/or carcinomatous meningitis and had stable disease for at least 3 months, and no evidence of progression within 4 weeks of first dose of study treatment. No evidence of new or expanded metastasis, and untreated with radiotherapy, surgery or steroid therapy within 4 weeks of first dose of study treatment.
  • History of allogeneic hematopoietic stem cell transplantation or organ transplantation; Patients who had received systemic steroid therapy within the last 2 years; Pregnancy or lactation; Positive results of HIV testing; Active HBV(hepatitis B virus) or HCV(hepatitis C virus) infection Active tuberculosis; Other disorders with clinical significance according to the researcher's judgment; Unwilling or unable to participate in all required study evaluations and procedures

Trial locations and contacts

1 site in 1 country.

xinan sheng, doctor. contact

010-88196348

doctor_sheng@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, MD, 010-88121122, guoj307@126.com

    Recruiting

Other trials in China

About this study

Official title: A Open-label, Single-arm, Phase Ib/II Study of RC48-ADC and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer

This is an open-label, single-arm, Phase Ib/II investigator-initiated trial of RC48-ADC combined with JS001 to evaluate the safety and pharmacokinetics of subjects with locally advanced or metastatic urothelial cancer

Being tested
RC48-ADC and JS001
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-ADC and JS001Drug

    Recombinant Humanized anti-HER2(Human epidermal growth factor receptor-2) Monoclonal Antibody-MMAE(Monomethyl Auristatin E) Conjugate For Injection and JS001 Injection

Study groups in NCT04264936
Study groupRoleWhat they receive
RC48-ADC and JS001ExperimentalNot described
Receives: Drug: RC48-ADC and JS001

What is being measured

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

  1. Adverse events

    rate of adverse events

    Measured: through study completion, an average of 1 year

  2. maximal tolerated dose

    dose-limiting toxity

    Measured: through study completion, an average of 1 year

Secondary outcomes (4)

  1. Peak Plasma Concentration(Cmax)

    Maximum observed plasma concentration

    Measured: through study completion, an average of 1 year

  2. Immunogenicity

    Numbers of participants with anti-drug antibody positive

    Measured: through study completion, an average of 1 year

  3. objective response rate

    evaluated by RECIST 1.1 every 8 weeks

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first；assessed up to 60 months

  4. the area under the curve (AUC)

    Area under the plasma concentration versus time curve

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted11 Feb 2020
  2. Study start15 Feb 2020 (estimated)
  3. Primary completion30 Jan 2021 (estimated)
  4. Study completion31 Dec 2021 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264936
Sponsor's protocol ID
RC48-C014
Status last verified
Feb 2020
First submitted
15 Jan 2020
Last updated
13 Feb 2020
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 1/2 study testing RC48-ADC and JS001 in people with Urothelial Carcinoma, run by Peking University Cancer Hospital & Institute 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 13 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2020. 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 combined 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.

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?

Results are not available in the source record.

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

Contact xinan sheng, doctor. (010-88196348, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: through study completion, an average of 1 year). 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 NCT04264936.

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 Feb 2020.

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