Vulvar AdenocarcinomaPhase 1FOCUS-01NCT07454642
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
A Phase 1 study testing AVA6103 in people with Vulvar Adenocarcinoma and PDAC - Pancreatic Ductal Adenocarcinoma, run by Avacta Life Sciences Ltd at 7 sites in United States.
Trial summary
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma
- What is being tested?
- AVA6103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2026to Jun 2030
- 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
- The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
- Male or female subjects, ≥18 years of age.
- Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments
- Cervical/vulvar cancer
- SCLC
- Gastric/GEJ cancer
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- PDAC
- CRC
- HR+ breast cancer
- Has a life expectancy of ≥3 months, in the opinion of the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).
- Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):
- Absolute neutrophil count of ≥1.5 × 109 cells/L. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells/L
- Hemoglobin ≥9.0 g/dL.
- Platelet count of ≥100,000/µL.
- International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.
- Has adequate liver function:
- Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin <3 × ULN).
- AST and ALT ≤2.5 × ULN (in subjects with liver metastases, <5 × ULN is allowed).
- Has adequate renal function as defined by creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault equation.
- Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.
- Contraception requirements:
- Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate < 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.
- Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate <1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.
- Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.
- The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.
- For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional, except for patients assigned to backfill slots, where biopsies are mandatory.
- -
Who cannot join
- Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg/day or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.
- Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.
- Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
- History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
- History of known infection is defined as:
- HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load >400 copies/mL prior to study Day 1.
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- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).
- Subjects with active disease who are not on/have not initiated anti-retroviral treatment prior to study Day 1.
- Subjects with untreated HCV infection or have not completed treatment for HCV infection.
- Subjects with treated HCV infection but with an HCV viral load above the level of quantification.
- Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.
- Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.
- Is a pregnant or breastfeeding woman.
- Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.
- Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.
- Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:
- Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.
- Subjects who have received a monoclonal antibody.
- Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.
- Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.
- Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and/or where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.
- Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.
- Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.
- Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done >96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.
- QT interval corrected through use of Fridericia's formula (QTcF) > 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Giana Alzein, 773-702-7871, Giana.Alzein@bsd.uchicago.edu
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Maybelle De La Rosa, (703) 783-4518, mdelarosa@nextoncology.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Ronan Pleass, ronan.pleass@startresearch.com
- Recruiting
NEXT Oncology
Irving, Texas, 75039
Mofopefoluwa Akinwale, (972) 893-8800, fakinwale@nextoncology.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Elaha Marwa Khwaja, 646-888-4331, khwajae2@mskcc.org
- Recruiting
Florida Cancer Specialists and Research Institute
Sarasota, Florida, 34232
Pacia Eckert, BSN, RN, (941) 377-9993 ext. 1651, Pacia.Eckert@flcancer.com
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
Mia Carlson, BSN, RN, (480) 583-7209, micarlson@honorhealth.com
About this study
Official title: A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Read the detailed description
Phase 1a (Dose Escalation): The dose-escalation portion is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6103, administered as monotherapy in two schedules: Day 1 of a 21-day cycle (Q3W schedule) and Day 1 of a 14-day cycle (Q2W schedule).
Phase 1b (Dose Expansion): The dose-expansion arm is based on review of data in the dose escalation phase, with AVA6103 administered at the RP2D.
- Conditions
- Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
- Being tested
- AVA6103
- Medical subject headings
- Small Cell Lung Carcinoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVA6103Drug
AVA6103 is a FAP-activated Exatecan
| Study group | Role | What they receive |
|---|---|---|
| AVA6103 Phase 1a Dose Escalation Q3W | Experimental | Patients in this arm will receive escalating doses of AVA6103 Q3W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. Receives: Drug: AVA6103 |
| AVA6103 Phase 1a Dose Escalation Q2W | Experimental | Patients in this arm will receive escalating doses of AVA6103 Q2W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. Receives: Drug: AVA6103 |
| AVA6103 Phase 1b Dose Expansion | Experimental | Patients in this arm will receive AVA6103 at the recommended phase 2 dose, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. Receives: Drug: AVA6103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).
Measured: From Day 1 until up to 30 days after last dose of study drug.
Dose-limiting toxicities (DLTs)
Incidence and nature of DLTs
Measured: 21 days from the first dose for the every 3 week dosing schedule and 28 days from the first dose for the every 2 week schedule
Secondary outcomes (8)
Objective response rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Measured: From Day 1 until up to 30 days after last dose of study drug.
Duration of Response (DoR)
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Measured: From Day 1 until up to 30 days after last dose of study drug.
Progression-free-survival (PFS)
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Measured: From Day 1 until up to 30 days after last dose of study drug.
Overall survival (OS)
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause
Measured: Up to one year after last dose of study drug.
Maximum plasma concentration
Cmax (maximum plasma concentration) of AVA6103, AVA10344, and exatecan following single and multiple dosing.
Measured: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC) of AVA6103, AVA10344, and exatecan following single and multiple dosing.
Measured: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Elimination half-life (t½)
Elimination half-life (t½) of AVA6103, AVA10344, and exatecan following single and multiple dosing.
Measured: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Apparent clearance (CL)
Apparent clearance (CL) of AVA6103, AVA10344, and exatecan following single and multiple dosing.
Measured: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start31 Mar 2026
- Primary completionJan 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AdenocarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avacta Life Sciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454642
- Sponsor's protocol ID
- ALS-6103-101
- Acronym
- FOCUS-01
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
- ClinicalTrials.gov ID
- NCT07454642
- Acronym / sponsor ID
- FOCUS-01 / ALS-6103-101
- Conditions
- Vulvar Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Gastric Adenocarcinoma, GEJ Adenocarcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Avacta Life Sciences LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 6 Mar 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 is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Detailed description
Phase 1a (Dose Escalation): The dose-escalation portion is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6103, administered as monotherapy in two schedules: Day 1 of a 21-day cycle (Q3W schedule) and Day 1 of a 14-day cycle (Q2W schedule).
Phase 1b (Dose Expansion): The dose-expansion arm is based on review of data in the dose escalation phase, with AVA6103 administered at the RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVA6103 Phase 1a Dose Escalation Q3W | Experimental | Drug: AVA6103Patients in this arm will receive escalating doses of AVA6103 Q3W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. |
| AVA6103 Phase 1a Dose Escalation Q2W | Experimental | Drug: AVA6103Patients in this arm will receive escalating doses of AVA6103 Q2W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. |
| AVA6103 Phase 1b Dose Expansion | Experimental | Drug: AVA6103Patients in this arm will receive AVA6103 at the recommended phase 2 dose, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, or death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
- Male or female subjects, ≥18 years of age.
- Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments
- Has a life expectancy of ≥3 months, in the opinion of the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (27 listed)
- Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg/day or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.
- Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.
- Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
- History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
- History of known infection is defined as:
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 |
|---|---|---|
| AVA6103AVA6103 is a FAP-activated Exatecan | Drug | AVA6103 Phase 1a Dose Escalation Q2W, AVA6103 Phase 1a Dose Escalation Q3W, AVA6103 Phase 1b Dose Expansion |
Primary outcome
Adverse events (AEs)
Time frame: From Day 1 until up to 30 days after last dose of study drug.
Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).
Dose-limiting toxicities (DLTs)
Time frame: 21 days from the first dose for the every 3 week dosing schedule and 28 days from the first dose for the every 2 week schedule
Incidence and nature of DLTs
8 secondary outcomes
Objective response rate (ORR)
Time frame: From Day 1 until up to 30 days after last dose of study drug.
Duration of Response (DoR)
Time frame: From Day 1 until up to 30 days after last dose of study drug.
Progression-free-survival (PFS)
Time frame: From Day 1 until up to 30 days after last dose of study drug.
Overall survival (OS)
Time frame: Up to one year after last dose of study drug.
Maximum plasma concentration
Time frame: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Area under the plasma concentration-time curve (AUC)
Time frame: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Elimination half-life (t½)
Time frame: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
Apparent clearance (CL)
Time frame: Timepoints are collected from pre-dose on Day 1 through 48 hours post-dose (Day 3) of the first cycle as well as from pre-dose on Day 1 through 24 hours post-dose (Day 2) in each subsequent cycle.
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 5 Oct 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.
7 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 AVA6103 in people with Vulvar Adenocarcinoma and PDAC - Pancreatic Ductal Adenocarcinoma, run by Avacta Life Sciences Ltd at 7 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 29 inclusion and 27 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Avacta Clinical Team (+44 (0)20 3911 0353, clinicaltrials@avacta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From Day 1 until up to 30 days after last dose of study drug.). The study lists 2 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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.