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Tests treatment safety and results for Non-Small Cell Lung Cancer, Colorectal Cancer, Renal...
Official title A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT06839105
What this study is testing
What is Taxol?
Taxol is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer, colorectal cancer, renal cell carcinoma, melanoma and other solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Both male and female people who are at least 18 years old at the time of signing the consent form;
- Inclusion of patients with advanced malignancies confirmed histologically or cytologically and meeting the following requirements:
- Single-agent dose escalation and expansion phase to include patients with advanced malignant tumors who have failed or are intolerant of standard...
- Therapeutic effect expansion stage of single drug:
- NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has progressed after...
You likely can't join if
- Received the following drugs or treatments before the first dose:
- received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose, or received...
- Major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for local bone/brain lesions allowed within 14 days...
- In combination therapy, patients who have been systematically treated with corticosteroids (\> 10 mg prednisone per day or equivalent) or other...
- There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in the past, imaging examination within 4...
- Immune-related adverse events that led to permanent discontinuation occurred during previous immunosuppressive therapy (such as anti-PD -(L)1...
See the full eligibility criteria
Who can join
- Both male and female people who are at least 18 years old at the time of signing the consent form;
- Inclusion of patients with advanced malignancies confirmed histologically or cytologically and meeting the following requirements:
- Single-agent dose escalation and expansion phase to include patients with advanced malignant tumors who have failed or are intolerant of standard treatment, or have no standard treatment options;
- Therapeutic effect expansion stage of single drug:
- NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has progressed after prior treatment with PD-(L)1 antibody and platinum-containing chemotherapy...
- Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \> Adjuvant and neoadjuvant therapy that...
- CRC: colorectal adenocarcinoma or rectal adenocarcinoma with histologically confirmed PD-L1 composite positive score [CPS] ≥1, failure or intolerance of standard treatment, or no standard treatment options. PD-L1...
- RCC: Histologically confirmed metastatic or unresectable clear cell type of RCC with disease progression after previous treatment with targeted anti-angiogenesis therapy and PD-(L)1 inhibitors.
- Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment or have no standard treatment options.
- Combination phase:
- NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has not progressed after prior treatment with PD-(L)1 antibody and platinum-containing...
- CRC: Histologically confirmed PD-L1 CPS≥1 colorectal adenocarcinoma or rectal adenocarcinoma without prior systemic therapy (except after the last dose of medication \> Adjuvant therapy that progresses within 6 months)...
- RCC: Histologically confirmed metastatic or unresectable clear cell RCC with disease progression after previous treatment with anti-angiogenesis targeted therapy and PD-(L)1 inhibitors.
- Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \> Adjuvant therapy that progresses within 6...
- HCC: Histologically/cytologically confirmed or cirrhotic patients meet the clinical diagnostic criteria for HCC in AASLD, are identified as having stage B (intermediate) or stage C (advanced) BCLC HCC and are not...
- Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment, or have no standard treatment options.
- ECOG score is 0 or 1;
- Expected survival ≥12 weeks;
- Have at least one measurable lesion according to RECIST 1.1 evaluation criteria;
- Good organ function;
- Fertile female or male people must agree to be childfree during the study period until 6 months after the end of the last dose and voluntarily take highly effective contraception with their partner; The serum pregnancy...
- Patients participate voluntarily, give full informed consent, sign written informed consent, and have good compliance.
What rules you out
- Received the following drugs or treatments before the first dose:
- received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose, or received oral fluorouracil, small molecule targeted drugs or Chinese medicines...
- Major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for local bone/brain lesions allowed within 14 days before the first dose), coarse needle puncture biopsy or other minor...
- In combination therapy, patients who have been systematically treated with corticosteroids (\> 10 mg prednisone per day or equivalent) or other immunosuppressants for more than 1 week within 2 weeks prior to initial...
- There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in the past, imaging examination within 4 weeks before the first medication indicates stable brain metastases...
- Immune-related adverse events that led to permanent discontinuation occurred during previous immunosuppressive therapy (such as anti-PD -(L)1, CTLA-4, LAG-3 inhibitors, etc.);
- There are pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms that require repeated treatment (puncture or drainage, etc.);
- There is a history of interstitial lung disease or a history of non-infectious pneumonia treated with corticosteroids, or imaging evidence of active pneumonia during the screening period;
- The presence of severe, unhealed or split wounds, active ulcers, or untreated fractures (other than old fractures assessed by the investigator without clinical intervention);
- Obvious bleeding tendency or severe coagulation dysfunction;
- Have poorly controlled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure \> 100 mmHg), or have a history of hypertensive crisis or hypertensive encephalopathy;
- The toxicity of previous antitumor therapy did not return to the level ≤ Class 1 prescribed by CTCAE v5.0 or the level specified by the inclusion/exclusion criteria, except in the following cases: The related toxicity...
- Severe infection occurred within 28 days prior to administration in the first study (CTCAE v5.0\> Grade 2), such as severe pneumonia, bacteremia, infection complications that require hospitalization; Active infection...
- Clinically significant hemoptysis for any reason (such as blood loss reaching or exceeding 50 ml/ day, or accompanied by clinical symptoms such as dyspnea and shortness of breath) or tumor bleeding (such as significant...
- Gastrointestinal perforation, fistula, abdominal abscess, bleeding, or definite bleeding tendency (including but not limited to: severe esophagofundus varicose veins with bleeding risk, locally active digestive ulcer...
- Severe cardiovascular and cerebrovascular diseases, including but not limited to, History of myocardial infarction, severe/unstable angina pectoris, congestive heart failure (NYHA cardiac function rating ≥2), clinically...
- Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) are present within 2 years prior to initial medication, including but not limited to systemic systemic lupus...
- Had suffered from another malignant tumor within 5 years before the first medication; However, local tumors that have been cured are excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate...
- Active tuberculosis, hepatitis B (HBsAg positive with HBV DNA higher than 1000 copies /ml or 200 IU/ml), hepatitis C (HCVAb positive with HCV RNA higher than the lower limit of detection);
- A history of immunodeficiency, including HIV testing positive, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study, affect treatment compliance, or interfere with the study results...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Luoyang, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China; Luoyang, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.