Solid TumorsPhase 1NCT02881190
Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in 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 tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 57 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2015to 8 Nov 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Aged 18-75 years;
- ECOG physical condition is 0 or 1;
- Life expectancy greater than 12 weeks;
- Patients with locally advanced or metastatic malignant solid tumors diagnosed by pathology and refractory to standard of care therapy, or for whom no standard of care therapy is available histology standard of care therapy, or for whom no standard of care therapy is available;
- Human epidermal growth factor receptor 2 (HER2)-positive refers to immunohistochemistry (IHC 2+or 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) <=3.0*upper limit of normal (ULN), or AST and ALT<=5*ULN if liver function abnormalities are due to underlying malignancy;
- normal serum creatinine;
- 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% as assessed by echocardiogram.
Who cannot join
- Current pregnancy or lactation;
- Serologic status reflecting active hepatitis B or C infection;
- 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;
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade less than or equal to1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia;
- Prior-treatment with other clinical research anticancer drugs within 28 days before study drug treatment;
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- The active infection with clinical significance According to the researcher's judgment,
- Known history of immune deficiency,including HIV-positive or other known acquired or congenital immunodeficiency, or organ transplantation;
- 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;
- Unwilling or unable to participate in all required study evaluations and procedures;
- The time interval which is from the last chemotherapy or HER2 targeted therapy until the first trial is more than 21 days;
- Patients who had received systemic steroid therapy for a long time (Patients who had received systemic steroid therapy for short time and stopped drug more than 2 weeks could be enrolled);
- Serious complications such as active alimentary tract hemorrhage, intestinal obstruction, enteroparalysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma and uncontrolled diabetes;
- Uncontrolled primary or metastatic tumor of brain;
- Current peripheral neuropathy of Grade ≥ 2;
- History of nerve or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Tolerance, Safety and Pharmacokinetic Ascending Dose Phase I Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive Malignant in Advanced Malignant Solid Tumors
A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.
- 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 | The phase I component has several dose levels of RC48-ADC (0.1mg/kg，0.5 mg/kg, 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg, 3.0mg/kg, 3.5mg/kg and 4.0 mg/kg) and is designed as a traditional dose-escalation study.Dosing interval is once two weeks. 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
The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.
Measured: DLT will be evaluated on Day 28 during cycle 1
Secondary outcomes (1)
Safety (the drug safety as assessed by NCI-CTCAE v4.0)
The drug safety as assessed by NCI-CTCAE v4.0
Measured: up to 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 start14 Dec 2015
- Primary completion27 Jun 2019
- Study completion8 Nov 2019
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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881190
- Sponsor's protocol ID
- C002 CANCER
- Status last verified
- Jun 2020
- First submitted
- 20 Aug 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu Y, Wang Y, Gong J, Zhang X, Peng Z, Sheng X, Mao C, Fan Q, Bai Y, Ba Y, Jiang D, Yang F, Qi C, Li J, Wang X, Zhou J, Lu M, Cao Y, Yuan J, Liu D, Wang Z, Fang J, Shen L. Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors. Gastric Cancer. 2021 Jul;24(4):913-925. doi: 10.1007/s10120-021-01168-7. Epub 2021 May 4.
PubMed 33945049
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tolerance, Safety and Pharmacokinetic Ascending Dose Phase I Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive Malignant in Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT02881190
- Acronym / sponsor ID
- C002 CANCER
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 8 Nov 2019 (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 tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.
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-ADCThe phase I component has several dose levels of RC48-ADC (0.1mg/kg，0.5 mg/kg, 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg, 3.0mg/kg, 3.5mg/kg and 4.0 mg/kg) and is designed as a traditional dose-escalation study.Dosing interval is once two weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent form;
- Aged 18-75 years;
- ECOG physical condition is 0 or 1;
- Life expectancy greater than 12 weeks;
- Patients with locally advanced or metastatic malignant solid tumors diagnosed by pathology and refractory to standard of care therapy, or for whom no standard of care therapy is available histology standard of care therapy, or for whom no standard of care therapy is available;
Key exclusion criteria (16 listed)
- Current pregnancy or lactation;
- Serologic status reflecting active hepatitis B or C infection;
- 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;
- Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade less than or equal to1, or to the levels dictated in the inclusion/exclusion criteria with the 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 Day 28 during cycle 1
The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.
1 secondary outcome
Safety (the drug safety as assessed by NCI-CTCAE v4.0)
Time frame: up to 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 4 Jun 2020.
- Derived from this study: PubMed 33945049Xu Y, Wang Y, Gong J, Zhang X, Peng Z, Sheng X, Mao C, Fan Q, Bai Y, Ba Y, Jiang D, Yang F, Qi C, Li J, Wang X, Zhou J, Lu M, Cao Y, Yuan J, Liu D, Wang Z, Fang J, Shen L. Phase I study of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors. Gastric Cancer. 2021 Jul;24(4):913-925. doi: 10.1007/s10120-021-01168-7. Epub 2021 May 4.
- 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.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
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 16 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 4 Jun 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 Day 28 during cycle 1). 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 NCT02881190, 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 4 Jun 2020.