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HER2-Positive Solid TumorsPhase 1NCT04280341

JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors

A Phase 1 study testing RC48-ADC in combinaton with JS001 in people with HER2-Positive Solid Tumors, run by Peking University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-Positive Solid Tumors
What is being tested?
RC48-ADC in combinaton with JS001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
3 Jun 2020to Dec 2024
Phase
Phase 1
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

  • Willing to sign the informed consent form;
  • ≥18 years old;
  • Diagnosed histologically or cytologically with local advanced or metastatic HER2-positive malignant solid cancer( indicating that IHC result is 2+,3+or1+ ) and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable;
  • Having measurable or evaluable lesions according to RECIST 1.1;
  • Having an ECOG performance status score of 0 or 1;
  • Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.
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  • NYHA CLAS 0-1;
  • Having sufficient bone marrow, liver and kidney functions (based on the normal value of the clinical trial site) within 7 days before erollment: Absolute neutrophil count (ANC) ≥ 1.5×109/L,Platelets ≥ 100×109/L, hemoglobin≥ 9.0 g/dL；Total serum bilirubin ≤ 1.5×upper limit of normal (ULN);Without liver metastasis, ALT, AST or ALP ≤ 2.5×ULN; With liver metastasis, ALT, AST or ALP ≤ 5×ULN;Serum creatinine clearance rate ≥ 60 mL/min(Cockcroft-Gault formula);INR International Normalized Ratio ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
  • With an expected survival of more than 3 months;
  • Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives and intrauterine devices) during the study period and within 24 weeks after the last dosing;

Who cannot join

  • Known active uncontrolled or symptomatic CNS metastases, as indicated by clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable o before the first dose of RC48-ADC.
  • Prior treatment with HER2 targeted therapy while LVEF decline <45% or absolute value of LVEF decline >15%；
  • Participation in any other studies within 4 weeks before study entry and/or during participation in the active treatment phase of the trial.
  • Radical operation within 3 weeks before study entry but not include diagnostic puncture or peripheral vascular assess replacement ;
  • Radical radiation therapy within 3 months before study entry; Patient of Palliative radiotherapy is eligible into this study if <30 % Radiation area of bone marrow;
  • Patients who underwent checkpoint inhibitor or tumor vaccines include not limited PD-1、 PD-1、PD-L1、CTLA4、LAG3;
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  • Patient has had systemic steroid therapy (≥10 mg/day of prednisone or physiologic replacement doses of hydrocortisone, or its equivalent) or immunosuppressive medication within 14 days prior to the first dose of study.
  • Live vaccines within 28 days prior to the first dose of study and during trial treatment.
  • Patient has an active autoimmune disease or a documented history of autoimmune disease (but not limited In terstitial lung Disease, uveitis, SLE, etal). Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with vitiligo or psoriasis that is stable on hormone replacement will not be excluded from the study.
  • Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Patients have uncontrollable systemic disease which including diabetes, hypertendion, pulmonary fibrosis, etal.
  • The toxicity of previous anti-cancer therapy has not returned to 0 or 1 level as specified in CTCAE v4.0 (except for hair loss);
  • Patient has a history of allogeneic HSCT or organ transplation before study entry;
  • Patients with hypersensitivity or delayed hypersensitivity reactions to certain components of RC48-ADC or similar drugs;
  • Patients with symptomatic include but not limited ascites or pleural effusion and mental disease.

Trial locations and contacts

1 site in 1 country.

lin Shen, professor contact

86-10-88196561

linshenpku@163.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Shen Lin, Professor, 010-88196561, Linshenpku@163.com

    Shen Lin, professor

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose Escalation Clinical Trial to Assess the Safety, Efficacy, Tolerability and Pharmacokinetics of the Recombinant Humanized Anti-PD1 Monoclonal Antiody (JS001) in Combination With Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate (RC48-ADC) in Treatment of HER2-Positive Advanced Malignant Solid Tumors

This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in Treatment of HER2-Positive Advanced Malignant Solid Tumors.

Read the detailed description

The study has 2 parts which include dose escalation phase and dose extension phase.

Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg . Escalation will continue until identification of a MTD.

Dose of phase II and extenstion stage which based-results of escalation phase will be recommend.

Being tested
RC48-ADC in combinaton with JS001
Keywords
RC48-ADC, JS001, HER2 positive solid Tumor

What participants receive

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

  • RC48-ADC in combinaton with JS001Biological

    The study has 2 parts which include dose escalation phase and dose extension phase.

    Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg

Study groups in NCT04280341
Study groupRoleWhat they receive
RC48-ADC in combinaton with Anti-PD1 Monoclonal AntibodyExperimentalRC48-ADC(Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate) JS001(Recombinant Humanized Anti-PD1 Monoclonal Antibody)
Receives: Biological: RC48-ADC in combinaton with JS001

What is being measured

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

  1. DLT(dose-limiting toxicity) or Maximal Tolerance Dose (MTD)

    Side effects of drug or treatment that are serious enough to prevent an increase in dose or level of that treatment. The MTD is defined as the previous dose level.

    Measured: 28 days

  2. adverse events

    Safety of participants followed for the duration of hospital stay, an expected average of 1 week

    Measured: 1 year

Secondary outcomes (9)

  1. ORR

    Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. DOR

    The percentage of patients who achieve complete remission(CR) or partial remission

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  3. PFS

    progression free survival

    Measured: up to 2 years

  4. OS

    overall survival

    Measured: up to 2 years

  5. ADA

    anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

    Measured: up to 2 years

  6. NADA

    neutralizing anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

    Measured: up to 2 years

  7. Cmax

    Peak plasma concentration

    Measured: up to 3 cycles(each cycle is 14 days)

  8. AUC

    area under the plasma concentration versus time curve

    Measured: up to 3 cycles(each cycle is 14 days)

  9. Tmax

    Time for peak concentration

    Measured: up to 3 cycles(each cycle is 14 days)

Timeline

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

  1. First posted21 Feb 2020
  2. Study start3 Jun 2020
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04280341
Sponsor's protocol ID
RC48-C013
Status last verified
Aug 2023
First submitted
30 Dec 2019
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Y, Gong J, Wang A, Wei J, Peng Z, Wang X, Zhou J, Qi C, Liu D, Li J, Lu M, Lu Z, Cao Y, Yuan J, Zhang R, Fang J, Zhang X, Shen L. Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial. EClinicalMedicine. 2024 Jan 5;68:102415. doi: 10.1016/j.eclinm.2023.102415. eCollection 2024 Feb.

    PubMed 38235421

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RC48-ADC in combinaton with JS001 in people with HER2-Positive Solid Tumors, run by Peking University 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 10 inclusion and 15 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 25 Aug 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 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?

Results are not available in the source record.

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

Contact lin Shen, professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT(dose-limiting toxicity) or Maximal Tolerance Dose (MTD) (time frame: 28 days). 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 NCT04280341, 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 25 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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