Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid TumorPhase 1NCT06839105

A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

A Phase 1 study testing Taxol, Cisplatin or Carboplatin and Pemetrexed in people with Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor, run by Shanghai Junshi Bioscience Co., Ltd. at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor
What is being tested?: Taxol, Cisplatin or Carboplatin and Pemetrexed
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 214 participants
Where: 13 sitesChina
Study dates: 21 Feb 2025to 30 Apr 2028
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

Both male and female subjects 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 (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.

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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 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study).
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.
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); In patients with MSI-H/dMMR, previous treatment with PD-(L)1 inhibitors is permitted. PD-L1 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study).
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;
Have at least one measurable lesion according to RECIST 1.1 evaluation criteria;
Good organ function;
Fertile female or male subjects 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 test for WOCBP must be negative within 7 days prior to the first dose and must be non-lactation (specific contraceptive methods and WOCBP definitions are set out in section 10.3);
Patients participate voluntarily, give full informed consent, sign written informed consent, and have good compliance.

Who cannot join

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.);

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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 judged by the investigator to be well controlled and does not affect the safety and compliance of patients using the investigational drugs can be screened after confirmation with the sponsor;
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);
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 lesions [may be considered in investigators' assessment of ulcer stability], persistent positive stool occult blood, etc.) within 6 months before randomization; For patients with persistent positive stool occult blood, if they are patients with colorectal cancer or gastric cancer, and the positive occult blood test is believed to be related to tumor after detailed evaluation (such as local bleeding, ulcers, etc.), gastrointestinal bleeding is stable and does not cause clinical symptoms (such as anemia, hypotension, etc.) under tumor treatment or disease control, they can be considered for inclusion;
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;
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 carcinoma in situ;
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, patients who are judged by the investigator to be unsuitable for participation in the study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohong Ding, Master contact

13602465823

xiaohong_ding@junshipharma.com

City, postcode or hospital

Sites recruiting now only

13 sites in 1 country

China13 sites, 13 recruiting

The First Hospital of Jilin University
Changchun, Jilin
Di Wu, M.D, +86 13944888991, wudi888991@163.com
Di Wu, M.D
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Lin Wu, M.D, 021-22200000, shun_lu@hotmail.com
Lin Wu, M.D
Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin, M.D, +86 13705919382, linrongbo@fjzlhospital.com
Rongbo Lin, M.D
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Xiaoshi Zhang, M.D, +86 15915733209, zhangxsh@sysucc.org.cn
Xiaoshi Zhang, M.D
Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Meiyu Fang, M.D, +86 13750851650, fangmy@zjcc.org.cn
Meiyu Fang, M.D
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu, M.D, +86 13904505825, lfn540@126.com
Yan Yu, M.D
Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang, M.D, 13888876721, 13888876721@163.com
Runxiang Yang, M.D
Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471099
Zhiye Zhang, M.D, 13888876721, 13783100985@163.com
Zhiye Zhang, M.D
Not yet recruiting
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Longhua Sun, M.D, +86 18279110112, sunlonghua012024@163.com
Longhua Sun, M.D
Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200032
Shun Lu, M.D, 021-22200000, shun_lu@hotmail.com
Shun Lu, M.D
Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Yuan Liang, M.D, +86 18900917786, lnszl_ly@163.com
Yuan Liang, M.D
Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 400042
Funan Liu, M.D, +86 13609877906, lfn540@126.com
Funan Liu, M.D
Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, M.D, +86 13995607152, doctorlxj@163.com
Xinjun Liang, M.D
Recruiting

Other trials in China

About this study

Official title: 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

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

Conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor
Being tested: Taxol, Cisplatin or Carboplatin, Pemetrexed, Oxaliplatin, Capecitabine
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Renal Cell, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TaxolDrug
135~175 mg/m2, Q3W
Cisplatin or CarboplatinDrug
Cisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5~6, Q3W)
PemetrexedDrug
500 mg/m2, Q3W
OxaliplatinDrug
130 mg/m2, Q3W
CapecitabineDrug
1000 mg/m2, BID, day1-14, oral, q3w
BevacizumabDrug
7.5 mg/kg, Q3W
RenvastinibDrug
8mg or 20mg, QD
AWT020Drug
q3w or q2w, i.v.

Study groups in NCT06839105
Study group	Role	What they receive
AWT020	Experimental	If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. Receives: Drug: AWT020
AWT020 combination with taxol and cisplatin or carboplatin	Experimental	Not described Receives: Drug: Taxol; Drug: Cisplatin or Carboplatin; Drug: AWT020
AWT020 combination with Pemetrexed and cisplatin or carboplatin	Experimental	Not described Receives: Drug: Cisplatin or Carboplatin; Drug: Pemetrexed; Drug: AWT020
AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab	Experimental	Not described Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab; Drug: AWT020
AWT020 combination with Renvastinib	Experimental	Not described Receives: Drug: Renvastinib; Drug: AWT020

What is being measured

The primary outcome is the main question the study is designed to answer.

DLT rate
DLT rate
Measured: 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
Measured: 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
Measured: Up to approximately 12 months from first patient in
MTD
Determine maximum tolerated dose
Measured: Up to approximately 12 months from first patient in
RP2D
Recommended phase II dose (RP2D) for AWT020 monotherapy and combination therapy
Measured: Up to approximately 32 months from first patient in

Secondary outcomes (7)

Drug concentrations
Drug concentrations in individual subjects at different time points after dosing
Measured: Up to approximately 24 months from first patient in
Immunogenicity
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (Nab), titer of ADA positive samples
Measured: Up to approximately 24 months from first patient in
ORR
Efficacy endpoint: Objective response rate(ORR) per RECIST v1.1
Measured: Up to approximately 32 months from first patient in
DOR
Efficacy endpoint: Duration of response (DOR) per RECISIT v1.1
Measured: Up to approximately 32 months from first patient in
DCR
Efficacy endpoint: Disease control rate (DCR) per RECISIT v1.1
Measured: Up to approximately 32 months from first patient in
PFS
Efficacy endpoint: Progress -free survival (PFS) per RECISIT v1.1
Measured: Up to approximately 32 months from first patient in
OS
Efficacy endpoint: Overall survival (OS)
Measured: Up to approximately 32 months from first patient in

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202530 Apr 2028

First posted21 Feb 2025
Study start21 Feb 2025
Primary completion30 Apr 2028 (estimated)
Study completion30 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid TumorStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 214 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06839105
Sponsor's protocol ID: AWT020-001-I
Status last verified: Jul 2026
First submitted: 18 Feb 2025
Last updated: 2 Jul 2026
Results posted: 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06839105
Acronym / sponsor ID: AWT020-001-I
Conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 214 participants (estimated)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Study start: 21 Feb 2025 (actual)
Primary completion: 30 Apr 2028 (estimated)
Study completion: 30 Apr 2028 (estimated)
First posted: 21 Feb 2025 (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.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
AWT020	Experimental	Drug: AWT020If 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	Experimental	Drug: Taxol, Drug: Cisplatin or Carboplatin, Drug: AWT020
AWT020 combination with Pemetrexed and cisplatin or carboplatin	Experimental	Drug: Cisplatin or Carboplatin, Drug: Pemetrexed, Drug: AWT020
AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab	Experimental	Drug: Oxaliplatin, Drug: Capecitabine, Drug: Bevacizumab, Drug: AWT020
AWT020 combination with Renvastinib	Experimental	Drug: Renvastinib, Drug: AWT020

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Both male and female subjects 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:
ECOG score is 0 or 1;
Expected survival ≥12 weeks;
Have at least one measurable lesion according to RECIST 1.1 evaluation criteria;

Key exclusion criteria (21 listed)

Received the following drugs or treatments before the first dose:
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;

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
Taxol135~175 mg/m2, Q3W	Drug	AWT020 combination with taxol and cisplatin or carboplatin
Cisplatin or CarboplatinCisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5~6, Q3W)	Drug	AWT020 combination with Pemetrexed and cisplatin or carboplatin, AWT020 combination with taxol and cisplatin or carboplatin
Pemetrexed500 mg/m2, Q3W	Drug	AWT020 combination with Pemetrexed and cisplatin or carboplatin
Oxaliplatin130 mg/m2, Q3W	Drug	AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab
Capecitabine1000 mg/m2, BID, day1-14, oral, q3w	Drug	AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab
Bevacizumab7.5 mg/kg, Q3W	Drug	AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab
Renvastinib8mg or 20mg, QD	Drug	AWT020 combination with Renvastinib
AWT020q3w or q2w, i.v.	Drug	AWT020, AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab, AWT020 combination with Pemetrexed and cisplatin or carboplatin, AWT020 combination with Renvastinib, AWT020 combination with taxol and cisplatin or carboplatin

Primary outcome

DLT rate
Time frame: Up to approximately 12 months from first patient in
DLT rate
AE
Time frame: Up to approximately 12 months from first patient in
Safety endpoint: incidence and severity of AE, abnormal changes in clinically significant laboratory and other tests
SAE
Time frame: Up to approximately 12 months from first patient in
Safety endpoint: incidence and severity of SAE, abnormal changes in clinically significant laboratory and other tests
MTD
Time frame: Up to approximately 12 months from first patient in
Determine maximum tolerated dose
RP2D
Time frame: Up to approximately 32 months from first patient in
Recommended phase II dose (RP2D) for AWT020 monotherapy and combination therapy

7 secondary outcomes

Drug concentrations
Time frame: Up to approximately 24 months from first patient in
Immunogenicity
Time frame: Up to approximately 24 months from first patient in
ORR
Time frame: Up to approximately 32 months from first patient in
DOR
Time frame: Up to approximately 32 months from first patient in
DCR
Time frame: Up to approximately 32 months from first patient in
PFS
Time frame: Up to approximately 32 months from first patient in
OS
Time frame: Up to approximately 32 months from first patient in

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 2 Jul 2026.
Individual participant dataSharing planned: No

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.

Xiaohong Ding, Master contact

13602465823

xiaohong_ding@junshipharma.com

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 inclusion and 21 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 Xiaohong Ding, Master (13602465823, xiaohong_ding@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT rate (time frame: Up to approximately 12 months from first patient in). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06839105.

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 2 Jul 2026.