MelanomaPhase 1NCT05867303
A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
A Phase 1 study testing RC198 Injection in people with Melanoma and Urothelial Carcinoma, run by RemeGen Co., Ltd. at 5 sites in 2 countries.
Trial summary
Safety study of RC198 in Subjects with Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Urothelial Carcinoma, Renal Cell Carcinoma
- What is being tested?
- RC198 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Jun 2023to 31 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
- Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
- Subjects with locally advanced unresectable or metastatic solid tumors who experience disease progression after standard treatment, or unable to tolerate standard treatment, or refuse standard treatment.
- At least 1 measurable or evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
- Male or female aged ≥ 18 years.
- ECOG PS score of 0 or 1.
- Anticipated life expectancy of > 12 weeks.
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- Adequate bone marrow, liver, and renal function defined as:
- Absolute neutrophil count ≥ 1.5× 109/L.
- Absolute lymphocyte count ≥ 500/μL.
- Platelet ≥ 100 × 109/L.
- Hemoglobin ≥ 90 g/L without receiving erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), or granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days and blood transfusion including red blood cell and platelet transfusion in at least 7 days prior to first dose of investigational product.
- Total bilirubin ≤ 1.5 × ULN or up to 3 × ULN if Gilbert syndrome.
- Alanine aminotransaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × ULN when there is no liver metastasis. ALT, AST ≤ 5 × ULN when there is liver metastasis
- Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (using Cockcroft-Gault formula); Urine protein < 2 + or 24 hour total urine protein quantity < 1g.
- Activated partial thromboplastin time (APTT) ≤ 1.5× ULN; international normalized ratio (INR) ≤ 1.5.
- Left ventricular ejection fraction ≥ 50%, as determined by echocardiogram or multiple-gated acquisition (MUGA) scan.
- Willingness to avoid pregnancy or fathering children based on the criteria below:
- Women of childbearing potential (WOCBP) who engage in heterosexual intercourse or male subjects whose sexual partners are WOCBP must be able to and agree to use an acceptable, highly effective, double barrier contraception commencing from Screening, during study, and for 6 months after the last dose of investigational product, including:
- Simultaneous use of hormonal contraceptives and must agree to use the same hormonal contraceptive throughout the study, and a condom for the male partner.
- Simultaneous use of intrauterine device (IUD) and condom for the male partner.
- Simultaneous use of diaphragm or cervical cap and condom for the male partner.
- Sterile male partner (vasectomized for at least 6 months prior to first dose of investigational product).
- True abstinence, defined as no sexual intercourse (heterosexual couples). Periodic abstinence and withdrawal are not acceptable methods.
- Subjects with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required use contraception when this is their preferred and usual lifestyle.
- WOCBP must have a negative serum beta human-chorionic gonadotropin (β-hCG) pregnancy test at Screening and a negative pregnancy test on Day 1 of each cycle. In the event of a positive urine pregnancy test, a serum pregnancy test will be performed for confirmation.
- Must agree not to donate ova or sperm from Screening, during study, and for 6 months after the last dose of investigational product
- Must agree not to donate ova or sperm from Screening, during study, and for 6 months after the last dose of investigational product
Who cannot join
- Pregnant or lactating.
- Known to be human immunodeficiency virus (HIV) positive, with active hepatitis (HBV) characterized by elevated levels of HBV ribonucleic acid exceeding the ULN; or active hepatitis C (HCV) with positive HCV ribonucleic acid (RNA); Subjects who are Hepatitis B surface antigen positive or hepatitis B core antibody positive must have undetectable quantitative DNA polymerase chain reaction (PCR).
- Administration of a live vaccine within 28 days before first dose of investigational and during the study. Note: Seasonal vaccines for influenza or Coronavirus Disease 2019 (COVID-19) vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
- Previous anti-tumor therapies (including surgery, chemotherapy, traditional Chinese medicine, radiotherapy, immunotherapy, biological therapy, hormonal therapy, or investigational agents for cancer treatment) within 4 weeks or within 5 half-lives of anti-tumor agents, whichever is shorter, prior to the first dose of investigational product, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose of investigational product.
- Previous adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigator's opinion) or Baseline within 4 weeks prior to first administration of the investigational product.
- Experienced prior Grade 3 or higher immune-related toxicity that resulted in permanent drug discontinuation (subjects with prior temporary drug interruptions due to endocrinopathies etc. are eligible).
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- History of therapy with an agent targeting of IL-15 or IL-2.
- Known hypersensitivity to any excipient contained in the drug formulation of investigational products or supplements to be administered during the study.
- Uncontrolled diseases including:
- Uncontrolled infection requiring systematic antibiotics, antivirals or antifungals within 4 weeks prior to first administration of the investigational product.
- Active infection with COVID-19.
- Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti-tuberculosis therapy within 1 year prior to first administration of the investigational product.
- Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome, Severe or unstable angina pectoris, coronary or peripheral artery bypass grafting.
- Uncontrollable hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg).
- Systemic diseases, including diabetes pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.
- History of any arterial thromboembolic event within 6 months prior to the first administration of investigational product, including myocardial infarction, unstable angina pectoris, pulmonary embolism, cerebrovascular stroke, or transient ischemic attack, etc.
- History of deep vein thrombosis or any other severe thromboembolism within 3 months prior to the first administration of investigational product (implantable venous access port or catheter-derived thrombosis, or superficial venous thrombosis is not considered as "severe" thromboembolism).
- History of life-threatening bleeding, or Grade 3 or 4 gastrointestinal/variceal bleeding requiring blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of investigational product.
- History of other acquired/congenital immunodeficiency diseases.
- History of organ transplantation allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
- A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 7 days or other immunosuppressive medication(s) within 14 days of the first dose of investigational product. Subjects using physiologic replacement doses of prednisone at ≤ 10 mg/day, or its equivalent, are eligible.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Note: Subjects with the following diseases are not excluded:
- Controlled Type I diabetes.
- Hypothyroidism (provided it is managed with hormone replacement therapy only).
- Controlled celiac disease.
- Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia).
- Any other disease that is not expected to recur in the absence of external triggering factors.
- History or presence of metastatic brain tumors. Subjects with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment >10 mg or seizure prophylaxis for ≥ 4 weeks prior to first dose of investigational product.
- Have undergone major surgeries within 4 weeks prior to first dose of investigational product.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage within 7 days prior to first dose of investigational product.
- Under the treatment of heparin (eg, low molecular weight heparin [LMWH]) or other anticoagulants such as warfarin when administered at a therapeutic dose. Participants using prophylactic doses of heparin (LMWH) are eligible.
- Diagnosis of any other malignancy within 2 years prior to enrollment, except for the following if adequately treated:
- Local basal cell or squamous cell carcinoma of the skin or related localized.
- Non-melanoma skin cancer.
- Carcinoma in situ of the breast or of the cervix.
- Non-muscle invasive bladder cancer.
- Low grade (Gleason 6 or below) prostate cancer undergoing surveillance with no plans for treatment intervention or previously fully resected.
- History or presence of uncontrolled mental illness or drug abuse disorder in opinion of the Investigator.
- The subject is expected to be non-compliant with critical study procedures and is not willing or able to adhere to the study requirements.
- Subject is deemed inappropriate for this clinical study, or participation in this clinical study is deemed not in the best interest of the subject, at the discretion of the Investigator.
- Other acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or investigational product administration, interfere with the interpretation of study results, and disqualify the subject for study participation in the Investigator's judgment.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia3 sites
ICON Cancer Centre Wesley
Auchenflower, Queensland, 4066
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Cabrini Hospital Malvern
Malvern, Victoria, 3144
China2 sites
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430061
About this study
Official title: A Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Immunogenetic and Efficacy of RC198 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Safety study of RC198 in Subjects with Solid Tumors.
Read the detailed description
This is a Phase 1, first-in-human, open-label study to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RC198 in subjects with locally advanced unresectable or metastatic solid tumors for whom standard therapy does not exist, is no longer effective, or is not acceptable.
- Conditions
- Melanoma, Urothelial Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma
- Being tested
- RC198 Injection
- Keywords
- Locally advanced unresectable or metastatic solid tumors
- Medical subject headings
- Melanoma, Carcinoma, Transitional Cell, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC198 InjectionDrug
RC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle.
| Study group | Role | What they receive |
|---|---|---|
| RC198 Injection | Experimental | RC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle. Receives: Drug: RC198 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD based on number of dose-limiting toxicities (DLTs)
The maximum tolerated dose (MTD) will be assessed based on the number of patients experiencing DLTs, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Measured: First 4 weeks (28 days) after first dose of study drug
Determine Recommended Phase 2 Dose (RP2D)
The RP2D may be selected based on the MTD following consultation with the safety monitoring committee with all available data.
Measured: Informed consent through 28 days after the last dose of study drug
Incidence of Adverse Events [Safety and tolerability]
The adverse events occurring or worsening on or after the first dose of the study drug will be recorded.
Measured: Informed consent through 28 days after the last dose of study drug
Secondary outcomes (8)
Time to maximum serum concentration [Tmax]
Tmax of RC198
Measured: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Area under the serum concentration verus time curve [AUC]
AUC of RC198
Measured: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Maximum serum Concentration [Cmax]
Cmax of RC198
Measured: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Immunogenicity of RC198
Incidence of anti-drug antibody (ADA) against RC198
Measured: D1 of W1 and W3 during cycle 1, and D1 of W1 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Object Response Rate (ORR)
ORR will be determined according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. The ORR is defined as the number of patients are either complete response (CR) or partial response (PR), relative to the number of patients belonging to the study of interest
Measured: Screening, then every 6 weeks (±7 days) after Day 1 of Cycle 1 Week 1 until 14 days after the last dose of the study drug. Assessed up to 24 months.
Disease Control Rate (DCR)
DCR is the proportion of patients with disease control.
Measured: Screening, then every 6 weeks (±7 days) after Day 1 of Cycle 1 Week 1 until 14 days after the last dose of the study drug. Assessed up to 24 months.
Duration of response (DoR)
DoR is defined, for patients with response, as the time from first documentation of response (CR or PR) to the date of first documentation of progression of disease or death due to any causes whichever occurs first.
Measured: From first partial response (PR) or complete response (CR) until disease progression or death, whichever occurs first. Assessed up to 24 months.
Progression Free Survival (PFS)
PFS is defined as the time from the date of first administration to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first.
Measured: From the first dose until documented disease progression or death, whichever occurs first. Assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start5 Jun 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867303
- Sponsor's protocol ID
- RC198-G001
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Immunogenetic and Efficacy of RC198 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05867303
- Acronym / sponsor ID
- RC198-G001
- Conditions
- Melanoma, Urothelial Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma
- Keywords
- Locally advanced unresectable or metastatic solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 May 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.
Safety study of RC198 in Subjects with Solid Tumors.
Detailed description
This is a Phase 1, first-in-human, open-label study to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RC198 in subjects with locally advanced unresectable or metastatic solid tumors for whom standard therapy does not exist, is no longer effective, or is not acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC198 Injection | Experimental | Drug: RC198 InjectionRC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
- Subjects with locally advanced unresectable or metastatic solid tumors who experience disease progression after standard treatment, or unable to tolerate standard treatment, or refuse standard treatment.
- At least 1 measurable or evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
- Male or female aged ≥ 18 years.
- ECOG PS score of 0 or 1.
Key exclusion criteria (42 listed)
- Pregnant or lactating.
- Known to be human immunodeficiency virus (HIV) positive, with active hepatitis (HBV) characterized by elevated levels of HBV ribonucleic acid exceeding the ULN; or active hepatitis C (HCV) with positive HCV ribonucleic acid (RNA); Subjects who are Hepatitis B surface antigen positive or hepatitis B core antibody positive must have undetectable quantitative DNA polymerase chain reaction (PCR).
- Administration of a live vaccine within 28 days before first dose of investigational and during the study. Note: Seasonal vaccines for influenza or Coronavirus Disease 2019 (COVID-19) vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
- Previous anti-tumor therapies (including surgery, chemotherapy, traditional Chinese medicine, radiotherapy, immunotherapy, biological therapy, hormonal therapy, or investigational agents for cancer treatment) within 4 weeks or within 5 half-lives of anti-tumor agents, whichever is shorter, prior to the first dose of investigational product, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose of investigational product.
- Previous adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigator's opinion) or Baseline within 4 weeks prior to first administration of the investigational product.
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 |
|---|---|---|
| RC198 InjectionRC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle. | Drug | RC198 Injection |
Primary outcome
MTD based on number of dose-limiting toxicities (DLTs)
Time frame: First 4 weeks (28 days) after first dose of study drug
The maximum tolerated dose (MTD) will be assessed based on the number of patients experiencing DLTs, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Determine Recommended Phase 2 Dose (RP2D)
Time frame: Informed consent through 28 days after the last dose of study drug
The RP2D may be selected based on the MTD following consultation with the safety monitoring committee with all available data.
Incidence of Adverse Events [Safety and tolerability]
Time frame: Informed consent through 28 days after the last dose of study drug
The adverse events occurring or worsening on or after the first dose of the study drug will be recorded.
8 secondary outcomes
Time to maximum serum concentration [Tmax]
Time frame: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Area under the serum concentration verus time curve [AUC]
Time frame: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Maximum serum Concentration [Cmax]
Time frame: Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Immunogenicity of RC198
Time frame: D1 of W1 and W3 during cycle 1, and D1 of W1 during subsequent cycles, and EOT (7 days within subject discontinued study drug)
Object Response Rate (ORR)
Time frame: Screening, then every 6 weeks (±7 days) after Day 1 of Cycle 1 Week 1 until 14 days after the last dose of the study drug. Assessed up to 24 months.
Disease Control Rate (DCR)
Time frame: Screening, then every 6 weeks (±7 days) after Day 1 of Cycle 1 Week 1 until 14 days after the last dose of the study drug. Assessed up to 24 months.
Duration of response (DoR)
Time frame: From first partial response (PR) or complete response (CR) until disease progression or death, whichever occurs first. Assessed up to 24 months.
Progression Free Survival (PFS)
Time frame: From the first dose until documented disease progression or death, whichever occurs first. Assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RC198 Injection in people with Melanoma and Urothelial Carcinoma, run by RemeGen Co., Ltd. at 5 sites in 2 countries.
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 27 inclusion and 42 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, 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?
MTD based on number of dose-limiting toxicities (DLTs) (time frame: First 4 weeks (28 days) after first dose of study drug). The study lists 3 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 16 Aug 2024.