Solid TumorsPhase 1NCT04190823
A Study of RC98 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study testing RC98 in people with Solid Tumors, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RC98
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2020to 30 Dec 2023
- 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
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years.
- Predicted survival ≥ 12 weeks.
- Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic solid tumors.
- Measurable lesion according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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- Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:
- Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 90g/L; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L; Total bilirubin ≤ 1.5× ULN and ≤ 1.5× ULN with hepatic metastasis; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN; INR, APTT and PT ≤ 1.5× ULN; TSH or FT4 or FT3 in (1±10%) ULN.
- All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Who cannot join
- Known hypersensitivity to the components of RC98 for injection.
- Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
- Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
- History of receiving any research drug treatment within 4 weeks prior to trial treatment.
- History of major surgery, chemotherapy or radiotherapy within 4 weeks of planned start of trial treatment.
- History of arterial / venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before study medication.
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- NYHA Class III heart failure.
- Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- Currently known active infection with HIV or tuberculosis.
- Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or cirrhosis;
- Treated with corticosteroids or other immunosuppressants for the autoimmune disease within 14 days prior to the study treatment.
- Existing active, or have experienced autoimmune diseases that may recur (eg: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis Disease, etc.) or subjects with these disease risks.
- Pregnancy or lactation.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial.
- Presence of primary tumors of the nervous system, brain metastases and / or cancerous meningitis.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- History of receiving immune-enhancing therapy (eg, alpha-interferon, interleukin-2), hormone therapy, traditional Chinese medicine treatment, or palliative radiotherapy for bone metastases within 2 weeks of planned start of trial treatment.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC98 For Injection in Subjects With Advanced Malignant Solid Tumors
This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with advanced malignant solid tumors.
- Conditions
- Solid Tumors
- Being tested
- RC98
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC98Drug
Also called RC98 for Injection
Participants will be allocated to one of the following dose groups: 0.003, 0.03, 0.3, 2.5, 5.0, 10.0, 15.0 and 20.0 mg/kg, and receive one treatment of RC98 followed by 28 days of dose limited toxicity (DLT) observation period.
| Study group | Role | What they receive |
|---|---|---|
| RC98 | Experimental | Not described Receives: Drug: RC98 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03
Measured: From the day of ICF sign to 28 days after the day of the last treatment
Maximum Tolerated dose of RC98
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: 12 months
Secondary outcomes (2)
Objective Response Rate(ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Measured: 15 months
Progression Free Survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start15 Mar 2020
- Primary completion28 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190823
- Sponsor's protocol ID
- RC98-C001
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC98 For Injection in Subjects With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT04190823
- Acronym / sponsor ID
- RC98-C001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Dec 2019 (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.
This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with 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 |
|---|---|---|
| RC98 | Experimental | Drug: RC98 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary agreement to provide written informed consent.
- Male or female, Age ≥ 18 years.
- Predicted survival ≥ 12 weeks.
- Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic solid tumors.
- Measurable lesion according to RECIST 1.1.
Key exclusion criteria (19 listed)
- Known hypersensitivity to the components of RC98 for injection.
- Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
- Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
- History of receiving any research drug treatment within 4 weeks prior to trial treatment.
- History of major surgery, chemotherapy or radiotherapy within 4 weeks of planned start of trial treatment.
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 |
|---|---|---|
| RC98Also: RC98 for InjectionParticipants will be allocated to one of the following dose groups: 0.003, 0.03, 0.3, 2.5, 5.0, 10.0, 15.0 and 20.0 mg/kg, and receive one treatment of RC98 followed by 28 days of dose limited toxicity (DLT) observation period. | Drug | RC98 |
Primary outcome
Adverse events
Time frame: From the day of ICF sign to 28 days after the day of the last treatment
Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03
Maximum Tolerated dose of RC98
Time frame: 12 months
The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.
2 secondary outcomes
Objective Response Rate(ORR)
Time frame: 15 months
Progression Free Survival (PFS)
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Solid Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
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 RC98 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 10 inclusion and 19 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 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?
Results are not available in the source record.
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?
Adverse events (time frame: From the day of ICF sign to 28 days after the day of the last treatment). 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.