A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AWT020 Alone and in Combination With Other Antitumor Therapies in Patients With Advanced Malignancies
1 other identifier
interventional
214
1 country
13
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 21, 2025
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
May 31, 2025
May 1, 2025
3.2 years
February 18, 2025
May 30, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
DLT rate
DLT rate
Up to approximately 12 months from first patient in
AE
Safety endpoint: incidence and severity of AE, abnormal changes in clinically significant laboratory and other tests
Up to approximately 12 months from first patient in
SAE
Safety endpoint: incidence and severity of SAE, abnormal changes in clinically significant laboratory and other tests
Up to approximately 12 months from first patient in
MTD
Determine maximum tolerated dose
Up to approximately 12 months from first patient in
RP2D
Recommended phase II dose (RP2D) for AWT020 monotherapy and combination therapy
Up to approximately 32 months from first patient in
Secondary Outcomes (7)
Drug concentrations
Up to approximately 24 months from first patient in
Immunogenicity
Up to approximately 24 months from first patient in
ORR
Up to approximately 32 months from first patient in
DOR
Up to approximately 32 months from first patient in
DCR
Up to approximately 32 months from first patient in
- +2 more secondary outcomes
Study Arms (5)
AWT020
EXPERIMENTALIf needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
AWT020 combination with taxol and cisplatin or carboplatin
EXPERIMENTALAWT020 combination with Pemetrexed and cisplatin or carboplatin
EXPERIMENTALAWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab
EXPERIMENTALAWT020 combination with Renvastinib
EXPERIMENTALInterventions
Cisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5\~6, Q3W)
1000 mg/m2, BID, day1-14, oral, q3w
q3w or q2w, i.v.
Eligibility Criteria
You may qualify if:
- Both male and female subjects who are at least 18 years old at the time of signing the consent form;
- 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 (except after the last dose \> Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase 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 and neoadjuvant therapy that progresses within 6 months); Mucosal melanoma does not require prior PD-(L)1 inhibitor therapy.
- 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 chemotherapy (except after the last dose \> Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects carrying EGFR or ALK mutations were allowed to progress on kinase inhibitor therapy with a previous ≤1 line.
- 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 months).
- 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 candidates for radical surgery and/or local therapy, and have previously received PD-(L)1 inhibitors and anti-angiogenic targeted therapy progression.
- 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;
- +4 more criteria
You may not qualify 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 oral fluorouracil, small molecule targeted drugs or Chinese medicines with anti-tumor indications within 14 days before the first dose;
- 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 surgery within 7 days before the start of study therapy, excluding placement of vascular infusion devices;
- 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 administration are allowed to be treated with inhaled or topical steroids or ≤10 mg/ day systemic prednisone and equivalent doses of similar drugs;
- 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 without aggravation or new neurological symptoms, hormone therapy has been discontinued 2 weeks before the first medication, and screening is allowed; For meningeal and brainstem metastases, screening is not allowed regardless of treatment.
- 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;
- 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 requiring intravenous anti-infective therapy or fever of unknown origin \> 38.5℃ occurred within 2 weeks prior to the first study administration (as determined by the investigators, subjects with fever due to tumors could be enrolled);
- 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 bleeding caused by tumor, manifested as hemoptysis, hematemesis, bloody stool, etc., and the blood loss reaching 50 ml/ day or more) within 1 month before the first medication, Or accompanied by anemia, hypotension, shock and other symptoms);
- 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 significant supratrioventricular or ventricular arrhythmia requiring pharmacological intervention, aortic aneurysm requiring surgical repair, any arterial thromboembolism/embolism event, grade 3 or higher (CTCAE) within 6 months prior to administration v5.0) Venous thrombosis/embolism events, transient ischemic attacks, cerebrovascular accidents; Left ventricular ejection fraction (LVEF) by color Doppler ultrasound \< 50%. Corrected QTc\> 480ms (using the Fridericia method, if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is calculated);
- 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 erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, only thyroid, adrenal, or hypopituitarism, type 1 diabetes that can be controlled with hormone replacement therapy, psoriasis or vitiligo that does not require systemic treatment, and childhood asthma/allergies that have resolved are eligible for screening;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471099, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042, China
The First Hospital of China Medical University
Shenyang, Liaoning, 400042, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200032, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 21, 2025
Study Start
February 21, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share