Solid TumorsPhase 1NCT02881138
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
A Phase 1 study testing RC48-ADC in people with Solid Tumors, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RC48-ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 15 Jul 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Aged 18-65 years;
- ECOG physical condition is 0 or 1;
- Life expectancy greater than 12 weeks;
- Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or HER2-positive, locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
- Human epidermal growth factor receptor 2 (HER2)-positive as measured either by immunohistochemistry (IHC 2+ and by fluorescence in situ hybridization (FISH) or by immunohistochemistry (3+);
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- Patients with measurable and appreciable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- 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 bilirubin <=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 with hepatic metastasis;
- Serum creatinine clearance rate >=45ml/min;
- international normalized ratio (INR) and activated partial thromboplastin time (APTT) must be less than or equal to 1.5 times the upper limit of the normal range (ULN);
- 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;
- Left ventricular ejection fraction (LVEF) >= 50%.
Who cannot join
- Current pregnancy or lactation;
- Received anti-tumor treatment 4 weeks before study administration, including chemotherapy, radiotherapy, hormone therapy, biological therapy or immunotherapy, except the following: Gonadotropin-releasing hormone (GnRH) antagonistic therapy for prostate cancer and Hormone replacement therapy;
- Major surgery within 4 weeks of first dose of study drug and not fully recovered;
- Receiving palliative radiation therapy for bone metastases if administered <= 2 weeks prior to first study treatment;
- Toxicity of previous anti-tumor treatment has not recovered to CTCAE [version 4.0] 0-1 (with exception of alopecia);
- Participated in other clinical drug studies within 4 weeks;
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- Hypersensitivity or delayed allergic reaction to certain components of RC48-ADC or similar drugs;
- According to the judgment of the investigator, a clinically significant active infection;
- A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- Uncontrollable systemic diseases including diabetes, hypertension, lung Fibrosis, acute lung disease, interstitial lung disease, etc.;
- Congestive heart failure with grade 2 or higher (including grade 2) by the New York Institute of Cardiology (NYHA) of the United States in the history of diseases such as acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months before enrollment;
- Insufficient adherence to participate in this clinical study;
- Treated with Herceptin (Trastuzumab) within 60 days before the trial;
- Have received systemic steroid therapy for a long time ( short-term users who discontinue medication> 2 weeks can be selected);
- Uncontrolled primary or metastatic tumor of brain;
- Peripheral neuropathy with grade>= 2;
- People with a history of mental illness that is difficult to control.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
- Conditions
- Solid Tumors
- Being tested
- RC48-ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48-ADCDrug
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC | Experimental | Participants will be allocated to one of the following dose groups: 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC48-ADC followed by 28 days of dose limited toxicity (DLT) observation period. Receives: Drug: RC48-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal tolerance dose (MTD) of RC48-ADC
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
Measured: DLT will be evaluated on 28 days of observation period
AEs
The drug safety was assessed by investigator(s) according to NCI-CTCAE v4.0
Measured: Estimated 2 years
Secondary outcomes (3)
Cmax
Maximum Observed Plasma Concentration
Measured: Estimated 2 years
AUC
Area Under Curve
Measured: Estimated 2 years
Tmax
Time for Cmax
Measured: Estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Apr 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881138
- Sponsor's protocol ID
- C001 CANCER
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wang J, Liu Y, Zhang Q, Li W, Feng J, Wang X, Fang J, Han Y, Xu B. Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase I/Ib study. Cancer Commun (Lond). 2024 Jul;44(7):833-851. doi: 10.1002/cac2.12577. Epub 2024 Jun 28.
PubMed 38940019
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
- ClinicalTrials.gov ID
- NCT02881138
- Acronym / sponsor ID
- C001 CANCER
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC | Experimental | Drug: RC48-ADCParticipants will be allocated to one of the following dose groups: 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC48-ADC followed by 28 days of dose limited toxicity (DLT) observation period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent form;
- Aged 18-65 years;
- ECOG physical condition is 0 or 1;
- Life expectancy greater than 12 weeks;
- Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or HER2-positive, locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
Key exclusion criteria (17 listed)
- Current pregnancy or lactation;
- Received anti-tumor treatment 4 weeks before study administration, including chemotherapy, radiotherapy, hormone therapy, biological therapy or immunotherapy, except the following: Gonadotropin-releasing hormone (GnRH) antagonistic therapy for prostate cancer and Hormone replacement therapy;
- Major surgery within 4 weeks of first dose of study drug and not fully recovered;
- Receiving palliative radiation therapy for bone metastases if administered <= 2 weeks prior to first study treatment;
- Toxicity of previous anti-tumor treatment has not recovered to CTCAE [version 4.0] 0-1 (with exception of alopecia);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC48-ADC | Drug | RC48-ADC |
Primary outcome
maximal tolerance dose (MTD) of RC48-ADC
Time frame: DLT will be evaluated on 28 days of observation period
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
AEs
Time frame: Estimated 2 years
The drug safety was assessed by investigator(s) according to NCI-CTCAE v4.0
3 secondary outcomes
Cmax
Time frame: Estimated 2 years
AUC
Time frame: Estimated 2 years
Tmax
Time frame: Estimated 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 38940019Wang J, Liu Y, Zhang Q, Li W, Feng J, Wang X, Fang J, Han Y, Xu B. Disitamab vedotin, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpression and HER2-low advanced breast cancer: a phase I/Ib study. Cancer Commun (Lond). 2024 Jul;44(7):833-851. doi: 10.1002/cac2.12577. Epub 2024 Jun 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC48-ADC in people with Solid Tumors, 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 16 inclusion and 17 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: finished, as of the sponsor's last update on 30 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximal tolerance dose (MTD) of RC48-ADC (time frame: DLT will be evaluated on 28 days of observation period). 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 NCT02881138, 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 30 Jul 2020.