AzTrials
AzTrials

Recurrent High Grade Uterine CancerPhase 1NCT05826015

AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

A Phase 1 study testing Paclitaxel and Batiraxcept in people with Recurrent High Grade Uterine Cancer, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to determine safety and tolerability of AVB-500 when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent High Grade Uterine Cancer
What is being tested?
Paclitaxel and Batiraxcept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Oct 2024to 4 Jun 2034
Phase
Phase 1
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of recurrent, FIGO grade 3 endometrioid, serous, or mixed high grade uterine or endometrial cancer. Patients must have experienced either prior progression on a platinum-based therapy or intolerance to platinum. Patients with dMMR or MSI-H tumors or targetable HER2 alterations are required to have received prior therapy with appropriate targeted agents.
  • Patients must have disease that cannot be managed by local therapy.
  • Measurable disease by RECIST 1.1
  • Women or transgender men with a uterus who are at least 18 years of age.
  • ECOG performance status ≤ 2
  • Normal bone marrow and organ function as defined below:
Show all 17Show fewer
  • Absolute neutrophil count ≥ 1.5 K/cumm
  • Platelets ≥ 100 K/cumm
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (unless liver metastases are present in which case AST/ALT must be ≤ 5.0 x IULN)
  • Serum creatinine < 2.0 mg/dL or < 177 µmol/L OR calculated or measured creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault equation)
  • INR ≤ 1.5 x IULN
  • aPTT ≤ 1.5 x IULN
  • The effects of AVB-500 on the developing human fetus are unknown. For this reason and because chemotherapeutic agents are known to be teratogenic, patients of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a patient become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately.
  • Subjects who have received prior treatment with trastuzumab, pembrolizumab, or dostarlimab can enroll in the study.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Any prior treatment with AVB-500
  • A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
  • Currently receiving any other (non-study) cytotoxic chemotherapy, radiation, targeted treatment, or immunotherapy within 4 weeks prior of start of study treatment.
  • Currently receiving any other investigational agents or has received an investigational agent within 4 weeks of start of study treatment.
  • Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to AVB-500 or other agents used in the study.
Show all 19Show fewer
  • Abnormal gastrointestinal function, defined as Grade >2 diarrhea, constipation, nausea, vomiting, or abdominal pain. This includes GI obstruction or bleeding or signs/symptoms thereof within 3 months of study enrollment. Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula.
  • Significant cardiac disease history including:
  • Clinically significant atrial or ventricular arrhythmias requiring treatment
  • Medically controlled congestive heart failure
  • Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
  • Clinically significant valvular disease
  • Non-healing wound, ulcer, or bone fracture.
  • Known active hepatitis; ongoing systemic bacterial, fungal, or viral infection.
  • History or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, or history of CVA, TIA, or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • History of major surgical procedure within 14 days prior to start of study treatment.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).

About this study

Official title: Phase I/IB of AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

The purpose of this study is to determine safety and tolerability of AVB-500 when given in combination with paclitaxel in patients with recurrent high-grade uterine cancer.

Being tested
Paclitaxel, Batiraxcept
Keywords
Batiraxcept, AVB-500, uterine serous, high-grade endometrioid, paclitaxel

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    IV over 3 hours

  • BatiraxceptDrug

    Also called AVB-500

    IV over 60 minutes

Study groups in NCT05826015
Study groupRoleWhat they receive
Paclitaxel + AVB-500ExperimentalPatients will receive up to 9 21-day cycles of paclitaxel + AVB-500. Patients will receive AVB-500 via intravenous (IV) infusion at the assigned dose level on days 1, 8, and 15 of each cycle. Patients will receive IV paclitaxel at a dose of 175 mg/m^2 on day 1 of each cycle. After 3 cycles, patients will be assessed for disease response. Patients who have progression will not continue on treatment. Patients who have a partial response or stable disease will continue on treatment for another 3 cycles of paclitaxel + AVB-500 at the assigned dose. Patients will be assessed for response again at the end of 6 cycles and may continue on treatment if they have partial response (PR) or stable disease (SD). Up to 9 cycles of treatment with paclitaxel + AVB-500 may be given. At the end of the 9 cycles, patients with a SD or PR can continue on maintenance AVB-500 until progression. Patients with complete response will continue single agent AVB-500 as maintenance therapy until progression.
Receives: Drug: Paclitaxel; Drug: Batiraxcept

What is being measured

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

  1. Frequency and severity of treatment-emergent adverse events

    -Graded by CTCAE v.5.

    Measured: From start of treatment though 30 days after the last dose of AVB-500 (estimated to be 31 weeks)

Secondary outcomes (9)

  1. Serum sAXL and GAS6 ratio

    Measured: At baseline

  2. Pharmacokinetic (PK) parameters (including Cmax) as determined from AVB-500 serum levels

    Measured: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)

  3. Pharmacokinetic (PK) parameters (including Tmax) as determined from AVB-500 serum levels

    Measured: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)

  4. Pharmacodynamic effects as determined by changes from baseline in serum GAS6 levels

    Measured: Cycle 1 Day 1 pre-infusion, Cycle 1 Day 1 post-infusion, Cycle 1 Day 15 pre-infusion, and subsequent cycles day 1 pre-infusions (each cycle is 21 days)

  5. Overall response rate (ORR)

    -Defined as the proportion of subjects who have a partial or complete response to therapy

    Measured: Through completion of treatment (estimated to be 27 weeks)

  6. Progression-free survival (PFS)

    -Defined as the time from start of treatment to the first radiologically documented disease progression, or death, whichever comes first. The alive patients without radiologically documented disease progression are censored at the last follow-up.

    Measured: Through completion of follow-up (estimated to be 5 years and 27 weeks)

  7. Recommended Phase 2 dose (RP2D) of AVB-500 in combination with paclitaxel

    Measured: Through completion of cycle 1 (cycle=21 days) for all patients (estimated to be 48 months and 3 weeks)

  8. Incidence of anti-drug antibodies (ADA)

    Measured: Day 1 of each cycle (cycle-21 days) and end of treatment (estimated to be 27 weeks)

  9. Overall survival (OS)

    -Defined as the time from start of treatment to death. The alive patients are censored at the last follow-up.

    Measured: Through completion of follow-up (estimated to be 5 years and 27 weeks)

Timeline

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

  1. First posted24 Apr 2023
  2. Study start31 Oct 2024 (estimated)
  3. Primary completion3 Jun 2029 (estimated)
  4. Study completion4 Jun 2034 (estimated)

Why it stopped: Trial did not go forward

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826015
Sponsor's protocol ID
202306082
Status last verified
Sep 2024
First submitted
11 Apr 2023
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel and Batiraxcept in people with Recurrent High Grade Uterine Cancer, run by Washington University School of Medicine.

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 17 inclusion and 19 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: withdrawn, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of treatment-emergent adverse events (time frame: From start of treatment though 30 days after the last dose of AVB-500 (estimated to be 31 weeks)). 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 NCT05826015.

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 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in