Advanced Cancers (Solid Tumors)Phase 1NCT07822919
A Study of AWT020 in Participants With Advanced Solid Tumors
A Phase 1 study testing AWT020 in people with Advanced Cancers (Solid Tumors), run by Anwita Biosciences at 2 sites in United States.
Trial summary
This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers (Solid Tumors)
- What is being tested?
- AWT020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2026to Feb 2029
- 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
- Age 18 years or older; able to provide written informed consent and comply with study visits and procedures.
- Pathologically confirmed, unresectable advanced solid tumor.
- Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts.
- At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months.
- Adequate bone marrow, renal, hepatic, coagulation, and cardiac function as defined in the protocol.
- Meets protocol requirements for reproductive safety and tumor tissue availability.
Who cannot join
- Relevant hypersensitivity or intolerance to prior immunotherapy, interleukin-2 based therapy, monoclonal antibodies, or the study treatment; or prior immunotherapy discontinued because of an immune-related adverse event.
- Untreated or unstable central nervous system metastases, leptomeningeal disease, or brainstem metastases.
- Clinically significant autoimmune or skin disease requiring systemic treatment; Stevens-Johnson syndrome or toxic epidermal necrolysis; or current, suspected, or steroid-treated interstitial lung disease/pneumonitis.
- Unresolved toxicity from prior therapy, or recent anticancer treatment, major surgery, live vaccine, or other restricted therapy within protocol-defined washout periods.
- Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition.
- Active or recent severe infection.
- Prior allogeneic transplantation or adoptive cellular immunotherapy; concurrent investigational therapeutic trial; or pregnancy or breastfeeding.
- Another malignancy within 5 years, except permitted low-risk or in situ cancers; or any condition that increases risk, prevents consent or compliance, or could interfere with study interpretation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Alexander Spira, MD
- Recruiting
Florida Clinical Trials Group
Plantation, Florida, 33322
Spencer Herard, 772-297-3057, herards@floridactg.com
Harshad Amin, MD
About this study
Official title: A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors
This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.
Read the detailed description
This study will enroll participants who have undergone at least one systemic therapy and have progressive disease during or after most recent line of therapy, and for whom no further standard therapy (that is known to confer clinical benefit) is available, or who are intolerant of standard therapy. The study design consists of two parts: dose escalation (BOIN design) and dose optimization. Participants enrolled into this study will be assigned to one of 4 dose levels and will receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.
- Conditions
- Advanced Cancers (Solid Tumors)
- Being tested
- AWT020
- Keywords
- AWT020, anti-PD1, Interleukine-2, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWT020Biological
Participants receiving AWT020 once every three weeks at designated dose levels
| Study group | Role | What they receive |
|---|---|---|
| AWT020 | Experimental | Participants receiving intravenous infusion of AWT020 Receives: Biological: AWT020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) [Safety]
Type, incidence, and severity of Adverse Events (AEs)
Measured: Throughout the study up to 30 months
Serious Adverse Events (SAEs) [Safety]
Type, incidence, and severity of Serious Adverse Events (SAEs)
Measured: Throughout the study up to 30 months
Treatment-emergent Adverse Events (TEAEs) [Safety]
Type, incidence, and severity of treatment-emergent adverse events (TEAEs)
Measured: Throughout the study up to 30 months
Adverse Events of Special Interest (AESIs) [Safety]
Type, incidence, and severity of adverse events of special interest (AESIs)
Measured: Throughout the study up to 30 months
Dose-limiting Toxicities (DLTs) [Tolerability]
Incidence of dose-limiting toxicity (DLT)
Measured: Throughout the study up to 30 months
Secondary outcomes (16)
Maximum Observed Serum Concentration (Cmax)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout the study up to 30 months
Time to Cmax (Tmax)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout study up to 30 months
Area Under the Curve (AUC)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout the study up to 30 months
Clearance (CL)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout the study up to 30 months
Volume of Distribution (Vss)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout the study up to 30 months
Half-life (t1/2)
Blood samples will be collected to characterize the pharmacokinetics (PK) of AWT020
Measured: Throughout the study up to 30 months
Overall Response Rate (ORR)
Overall response rate (ORR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Throughout study up to 30 months
Disease Control Rate (DCR)
Disease control rate (DCR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Throughout the study up to 30 months
Progression-free Survival (PFS)
Time to response and duration of response assessed by the Investigator according to RECIST version 1.1
Measured: Throughout the study up to 30 months
Immune-related ORR (iORR)
Immune-related overall response rate (iORR) assessed by the Investigator according to immune RECIST (iRECIST)
Measured: Throughout the study up to 30 months
Immune-related DCR (iDCR)
Immune-related disease control rate (iDCR) assessed by the Investigator according to immune RECIST (iRECIST)
Measured: Throughout the study up to 30 months
Immune-related PFS (iPFS)
Immune-related progression-free survival (iPFS) assessed by the Investigator according to iRECIST
Measured: Throughout the study up to 30 months
Immune-related TTR (iTTR)
Immune-related time to response (iTTR) assessed by the Investigator according to iRECIST
Measured: Throughout the study up to 30 months
Immune-related DOR (iDOR)
Immune-related duration of response (iDOR) assessed by the Investigator according to iRECIST
Measured: Throughout the study up to 30 months
Overall Survival
The time from first dose of study treatment to death from any cause
Measured: Throughout study up to 30 months
Immunogenicity of AWT020
Incidence of anti-drug antibodies (ADAs)
Measured: Throughout study up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start11 Sep 2026 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cancers (Solid Tumors)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anwita Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harshad Amin, MD, Principal investigator, Florida Clinical Trials Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822919
- Sponsor's protocol ID
- AWT020-002
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07822919
- Acronym / sponsor ID
- AWT020-002
- Conditions
- Advanced Cancers (Solid Tumors)
- Keywords
- AWT020, anti-PD1, Interleukine-2, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Anwita BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2026 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Sep 2026 (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 is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.
Detailed description
This study will enroll participants who have undergone at least one systemic therapy and have progressive disease during or after most recent line of therapy, and for whom no further standard therapy (that is known to confer clinical benefit) is available, or who are intolerant of standard therapy. The study design consists of two parts: dose escalation (BOIN design) and dose optimization. Participants enrolled into this study will be assigned to one of 4 dose levels and will receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AWT020 | Experimental | Biological: AWT020Participants receiving intravenous infusion of AWT020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older; able to provide written informed consent and comply with study visits and procedures.
- Pathologically confirmed, unresectable advanced solid tumor.
- Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts.
- At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months.
- Adequate bone marrow, renal, hepatic, coagulation, and cardiac function as defined in the protocol.
Key exclusion criteria (8 listed)
- Relevant hypersensitivity or intolerance to prior immunotherapy, interleukin-2 based therapy, monoclonal antibodies, or the study treatment; or prior immunotherapy discontinued because of an immune-related adverse event.
- Untreated or unstable central nervous system metastases, leptomeningeal disease, or brainstem metastases.
- Clinically significant autoimmune or skin disease requiring systemic treatment; Stevens-Johnson syndrome or toxic epidermal necrolysis; or current, suspected, or steroid-treated interstitial lung disease/pneumonitis.
- Unresolved toxicity from prior therapy, or recent anticancer treatment, major surgery, live vaccine, or other restricted therapy within protocol-defined washout periods.
- Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition.
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 |
|---|---|---|
| AWT020Participants receiving AWT020 once every three weeks at designated dose levels | Biological | AWT020 |
Primary outcome
Adverse Events (AEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of Adverse Events (AEs)
Serious Adverse Events (SAEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of Serious Adverse Events (SAEs)
Treatment-emergent Adverse Events (TEAEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of treatment-emergent adverse events (TEAEs)
Adverse Events of Special Interest (AESIs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of adverse events of special interest (AESIs)
Dose-limiting Toxicities (DLTs) [Tolerability]
Time frame: Throughout the study up to 30 months
Incidence of dose-limiting toxicity (DLT)
16 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: Throughout the study up to 30 months
Time to Cmax (Tmax)
Time frame: Throughout study up to 30 months
Area Under the Curve (AUC)
Time frame: Throughout the study up to 30 months
Clearance (CL)
Time frame: Throughout the study up to 30 months
Volume of Distribution (Vss)
Time frame: Throughout the study up to 30 months
Half-life (t1/2)
Time frame: Throughout the study up to 30 months
Overall Response Rate (ORR)
Time frame: Throughout study up to 30 months
Disease Control Rate (DCR)
Time frame: Throughout the study up to 30 months
Progression-free Survival (PFS)
Time frame: Throughout the study up to 30 months
Immune-related ORR (iORR)
Time frame: Throughout the study up to 30 months
Immune-related DCR (iDCR)
Time frame: Throughout the study up to 30 months
Immune-related PFS (iPFS)
Time frame: Throughout the study up to 30 months
Immune-related TTR (iTTR)
Time frame: Throughout the study up to 30 months
Immune-related DOR (iDOR)
Time frame: Throughout the study up to 30 months
Overall Survival
Time frame: Throughout study up to 30 months
Immunogenicity of AWT020
Time frame: Throughout study up to 30 months
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Harshad Amin, MD principal investigator
Florida Clinical Trials Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AWT020 in people with Advanced Cancers (Solid Tumors), run by Anwita Biosciences at 2 sites in United States.
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 6 inclusion and 8 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Laksmi Wilson (650-600-9828, lwilson@anwitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) [Safety] (time frame: Throughout the study up to 30 months). 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?
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 23 Sep 2026.