Solid TumorPhase 1NCT05940896
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
A Phase 1 study testing Disitamab vedotin in people with Solid Tumor, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Disitamab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2023to 28 Feb 2027
- Phase
- Phase 1
- 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
- Voluntary signed informed consent,
- Male or female, aged ≥18 years,
- Predicted survival ≥ 12 weeks;
- Based on the investigator's evaluation (histopathological classification and clinical staging), patients with locally advanced solid tumors (head and neck squamous cell carcinoma, esophageal carcinoma, urothelium carcinoma, cervical carcinoma, etc), whose SOC is concurrent chemoradiation and cannot be surgically removed, are ineligible or refuse the standard chemotherapy.
- The subject has not been given any anti-tumor systemic therapy or radiotherapy for locally advanced solid tumors in the past
- HER2 expression is confirmed by the site: IHC 1+, 2+or 3+;
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- At least one measurable lesion according to RECIST 1.1.
- ECOG performance status score of 0 or 1;
- Adequate heart, bone marrow, liver, and kidney functions, which should meet the following standards within 7 days before the study drug is given (based on the normal values of the site) :
- Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L； Platelets ≥ 100 × 10^9/L； Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN； Blood creatinine ≤ 1.5 × ULN or calculate creatinine clearance rate (CrCl) ≥ 50 mL/min according to Cockcroft Fault formula method;
- Female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, and their blood pregnancy test must be negative within 7 days prior to study enrollment and they must be non-lactating. Male subjects: should be surgically sterile, or agree to use a medically approved contraceptive during study treatment and within 6 months after the end of study;
- Willing and able to comply with the schedules of the trial and follow-up procedures.
Who cannot join
- Received anti-tumor therapy before this study, including radiotherapy, target therapy, immunotherapy, and any anti-tumor clinical studies;
- The subject was given a major surgery and did not fully recover within 4 weeks prior to the study;
- Serum virology examination (based on the normal value of the site):
- HBsAg or HBcAb test results are positive, while HBV DNA copy is detected as positive; The HCVAb test result is positive (only when the PCR test result for HCV RNA is negative, can it be selected for this study); The HIVAb test result is positive.
- The subject was given live vaccine within 4 weeks before the study drug is given or planed to receive any vaccine during the study period (except for Covid-19 vaccine);
- Heart failure≥ 3 grade（NYHA）
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- Serious arteriovenous thrombotic events or cardiovascular and cerebrovascular accidents, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., occurred within one year before the study drug is given, except for lacunar cerebral infarction without symptoms or clinical intervention;
- There are active or progressive infections that require systematic treatment, such as active pulmonary tuberculosis;
- There are systemic diseases that have not been controlled stably as judged by the investigator, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc;
- Active autoimmune diseases that require systematic treatment (such as the use of immunomodulators, corticosteroids, or immunosuppressants) prior to the start of drug administration, allowing for related alternative treatments (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary dysfunction);
- Patients with other malignant tumors within 5 years prior to the start of study administration;
- Previously received other antibody conjugated drug treatments;
- Those who are known to be allergic to recombinant humanized anti HER2-ADC and components;
- Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer hospital &Institute
Jinan, Shandong
Jinming Yu, Ph.D
About this study
Official title: Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Disitamab Vedotin Intravenously Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression Phase 1 Study
To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression
Read the detailed description
This study is a single arm, open, single site clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of Disitamab Vedotin intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression. Unresectable locally advanced solid tumor patients whose SOC is concurrent chemoradiation but ineligible or refuse to standard chemotherapy should be enrolled.
- Conditions
- Solid Tumor
- Being tested
- Disitamab vedotin
- Keywords
- HER2 expression, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab vedotinDrug
Also called RC48-ADC
Disitamab Vedotin intravenously combined with radiotherapy (concurrent)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | DV is given intravenously once every 2 weeks, (dose escalation plan: 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg). DV will be administered at least 2 times during the treatment, and the final DV dose needs to be completed before the last radiotherapy. Receives: Drug: Disitamab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose limiting toxicity (DLT)
Measured: First DV dose to 28 days after the last RT
AE
the incidence and severity of adverse events (AE);
Measured: First DV dose to 90 days after the last RT
Secondary outcomes (3)
PK Characterize
The concentration of DV binding antibodies, total antibodies, and free MMAE.
Measured: Cycle1Day1 to Cycle1Day8 (each cycle is 14 days)
Immunogenicity assessment
Anti-RC48 antibodies
Measured: Cycle1Day1 to Cycle1Day8 (each cycle is 14 days)
ORR
(RECIST 1.1 standard, evaluated by investigators): objective response rate (ORR), the relationship between HER2 expression and therapeutic efficacy.
Measured: approximately 2 years from the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start29 Jun 2023
- Primary completion16 Nov 2024 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Model description
- DV is given intravenously once every 2 weeks, (dose escalation plan: 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg). DV will be administered at least 2 times during the treatment, and the final DV dose needs to be completed before the last radiotherapy. Concurrent standard radiotherapy for solid tumors is given for 5-7 weeks, 5 times per week.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinming Yu, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940896
- Sponsor's protocol ID
- RC48-C019
- Status last verified
- Nov 2023
- First submitted
- 8 May 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of Disitamab Vedotin Intravenously Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression Phase 1 Study
- ClinicalTrials.gov ID
- NCT05940896
- Acronym / sponsor ID
- RC48-C019
- Conditions
- Solid Tumor
- Keywords
- HER2 expression, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 16 Nov 2024 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Jul 2023 (actual)
- 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.
To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression
Detailed description
This study is a single arm, open, single site clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and efficacy of Disitamab Vedotin intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression. Unresectable locally advanced solid tumor patients whose SOC is concurrent chemoradiation but ineligible or refuse to standard chemotherapy should be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- DV is given intravenously once every 2 weeks, (dose escalation plan: 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg). DV will be administered at least 2 times during the treatment, and the final DV dose needs to be completed before the last radiotherapy. Concurrent standard radiotherapy for solid tumors is given for 5-7 weeks, 5 times per week.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: Disitamab vedotinDV is given intravenously once every 2 weeks, (dose escalation plan: 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg). DV will be administered at least 2 times during the treatment, and the final DV dose needs to be completed before the last radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary signed informed consent,
- Male or female, aged ≥18 years,
- Predicted survival ≥ 12 weeks;
- Based on the investigator's evaluation (histopathological classification and clinical staging), patients with locally advanced solid tumors (head and neck squamous cell carcinoma, esophageal carcinoma, urothelium carcinoma, cervical carcinoma, etc), whose SOC is concurrent chemoradiation and cannot be surgically removed, are ineligible or refuse the standard chemotherapy.
- The subject has not been given any anti-tumor systemic therapy or radiotherapy for locally advanced solid tumors in the past
Key exclusion criteria (14 listed)
- Received anti-tumor therapy before this study, including radiotherapy, target therapy, immunotherapy, and any anti-tumor clinical studies;
- The subject was given a major surgery and did not fully recover within 4 weeks prior to the study;
- Serum virology examination (based on the normal value of the site):
- HBsAg or HBcAb test results are positive, while HBV DNA copy is detected as positive; The HCVAb test result is positive (only when the PCR test result for HCV RNA is negative, can it be selected for this study); The HIVAb test result is positive.
- The subject was given live vaccine within 4 weeks before the study drug is given or planed to receive any vaccine during the study period (except for Covid-19 vaccine);
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 |
|---|---|---|
| Disitamab vedotinAlso: RC48-ADCDisitamab Vedotin intravenously combined with radiotherapy (concurrent) | Drug | Dose escalation |
Primary outcome
DLT
Time frame: First DV dose to 28 days after the last RT
Dose limiting toxicity (DLT)
AE
Time frame: First DV dose to 90 days after the last RT
the incidence and severity of adverse events (AE);
3 secondary outcomes
PK Characterize
Time frame: Cycle1Day1 to Cycle1Day8 (each cycle is 14 days)
Immunogenicity assessment
Time frame: Cycle1Day1 to Cycle1Day8 (each cycle is 14 days)
ORR
Time frame: approximately 2 years from the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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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.
Jinming Yu, MD principal investigator
Shandong Cancer Hospital and 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 Disitamab vedotin in people with Solid Tumor, 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 12 inclusion and 14 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 27 Nov 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?
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?
DLT (time frame: First DV dose to 28 days after the last RT). 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?
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 27 Nov 2023.