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Endometrial NeoplasmsPhase 1/2NCT07811232

A Study of AL58805 in Advanced, Metastatic GYN, STS or Breast Cancers

A Phase 1/2 study testing AL58805, AL8326 and Eribulin in people with Endometrial Neoplasms and Soft Tissue Sarcoma (STS), run by Advenchen Pharmaceuticals, LLC. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This phase 1b/2a study evaluates AL58805, an oral investigational drug that blocks PI3K and mTOR signaling, in combination with one of three anticancer treatments: AL8326 (veonetinib), eribulin, or fulvestrant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AL58805, AL8326 and Eribulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteUnited States
Study dates
1 Sep 2026to 1 Sep 2031
Phase
Phase 1/2
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

  • Subjects must meet all of the following inclusion criteria to be eligible for this study:
  • Age ≥ 18 years.
  • Histologically proven diagnosis of:
  • Pathologically confirmed recurrent or metastatic solid tumors such as Endometrial cancer, Cervical cancer, STS and Breast cancer;
  • Failure of at least 1 prior line of standard therapy (disease progression after treatment or intolerable treatment toxicities);
  • Patients with mismatch repair deficient/microsatellite-instability high tumors must have received a prior anti-PD-1/PD-L1 therapeutic agent.
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  • No standard and effective treatment available.
  • Have measurable disease defined by RECIST 1.1 confirmed by CT or MRI scan within 28 days of enrollment.
  • Life expectancy of ≥ 3 months at the time of enrollment.
  • Able to take orally administered study medication.
  • Have adequate baseline function and performance status within 28 days of enrollment:
  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥75,000/mm3 and Hemoglobin ≥ 9g/dl.
  • Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN) or if creatinine is > 1.5 x ULN, creatinine clearance must be > 50 mL/min.
  • Hepatic function: bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; No liver metastasis, AST and ALT ≤ 2.5 × ULN; When liver metastasis occurs, AST and ALT ≤ 5.0 × ULN.
  • Coagulation profile: international normalized ratio (INR) is ≤ 1.5 and an aPTT or PTT < 1.2 x ULN.
  • ECOG performance ≤ 2
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • No gastrointestinal diseases that affect drug absorption, such as malabsorption.
  • Women of child-bearing potential must agree to use contraceptive measures starting 1 week before C1D1 until 4 weeks after the last dose of study treatment and have a negative serum pregnancy test within 28 days of enrollment. The patient must be non-lactating; if a female patient has not yet reached menopause (menopause is defined as the cessation of menstruation for at least 12 consecutive months, with no other causes), and has not undergone sterilization (removal of the ovaries and/or uterus), she is considered to be fertile. Her sexual partner should use medically approved contraception during the treatment period and for 4 weeks after the treatment ends;
  • Provide written informed consent and authorization permitting release of Protected Health Information.
  • Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Treatment with an investigational agent within 28 days of enrollment.
  • Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.
  • Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life- threatening medical condition that required it.
  • Known allergy or intolerance to investigational drugs (e.g.AL58805, AL8326, eriblin, fulvestrant, etc.) and excipients. (For example, who have had intolerable adverse reactions such as local injection site pain or systemic discomfort after application of fulvestrant should be excluded.)
  • Other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer presents within the last 5 years prior to enrollment or whose previous cancer treatment contraindicates this protocol therapy.
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  • Myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease.
  • Pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least five minutes apart, defined as systolic BP >150 mm Hg or diastolic BP>90 mm Hg pressure.
  • QTc≥ 480 msec on screening ECG per Fridericia's formula.
  • History of or existing risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  • Concurrent use of concomitant medications that prolong the QT/QTc interval.
  • History of significant vascular disease (e.g. aortic aneurysm, aortic dissection, peripheral vascular disease).
  • Patients with severe chronic obstructive pulmonary disease (COPD) in acute exacerbation, severe pulmonary fibrosis (such as idiopathic pulmonary fibrosis with rapid disease progression), etc.
  • History or evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor; seizures not controlled with standard medical therapy; and history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of enrollment.
  • Subjects with metastatic CNS tumors may participate in this study if the subject is > 28 days from therapy completion (including radiation and/or surgery), is clinically stable at the time of study enrollment, and is not receiving corticosteroid therapy.
  • History of neurological or psychiatric disorder, such as dementia, which in the investigator's assessment may prevent protocol compliance.
  • Serious, non-healing wound, ulcer or bone fracture.
  • Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to C1D1 (a major surgical procedure is defined as requiring general anesthesia).
  • Diabetes with poor blood sugar control. (If a patient with diabetes requires long-term use of insulin or hypoglycemic drugs, with no history of hypoglycemic drug dose adjustment in the past 1 month, they may be considered for inclusion after investigator assessment, even if their HbA1c is between 7.5% and 8.0%.)
  • History of pancreatitis; history of renal disease that includes histologically confirmed glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy or other renal insufficiencies.
  • Proteinuria on urinalysis within 28 days of enrollment. Subjects discovered to have a urine protein of 1+ on dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection and demonstrate < 1000 mg protein per 24 hours or spot urine protein (mg/dL) to creatinine (mg/dL) ratio must be <1.0 to allow participation in the study.
  • Clinically significant, uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
  • Hemoptysis within 3 months prior to enrollment.
  • Acute or chronic liver disease, active hepatitis A, B, or C with known cirrhosis or liver dysfunction.
  • Active bacterial infections requiring IV antibiotics (excluding uncomplicated urinary tract infection).
  • Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
  • History of non-malignant gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months prior to enrollment that in the opinion of the investigator may place the subject at risk of side effects on an anti-angiogenesis product.
  • Intra-abdominal abscess within the last 3 months of enrollment.
  • Ascites or pleural effusion (CTCAE5.0 ≥2)
  • History of difficulty swallowing, malabsorption, active partial or complete bowel obstruction, or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption.
  • Anticoagulation therapy with warfarin. Subjects treated with heparin, low molecular weight heparin, or any other anticoagulant may be included provided the subject has been on a stable therapeutic dose of the anticoagulant for at least 14 days prior to enrollment.
  • Known history of human immunodeficiency virus infection (HIV) with viral load is detectable.
  • HBsAg-positive patients with HBV DNA ≥ 104 copies or ≥ 2000IU/mL, antiviral and liver protection treatment should be performed first, and they can be enrolled only when HBV-DNA ≤ 104 copies/mL (2000IU/mL), and continue to take antiviral drugs, monitor liver function and hepatitis B virus load; HCV antibody positive and HCV-RNA positive.
  • The investigator deems that the subject is not suitable to participate in this study.

Trial locations and contacts

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

Queenie Yang, PhD contact

8055301550

queeniey@advenchen.com

Judy Chen contact

judc@advenchen.com

United States1 site

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Marium Kaukab, MBBS, CCRP, 713-792-9868, surgery_regstartup@mdanderson.org

    Jeffrey Andrew How, MD, MPH, MS

Other trials in United States

About this study

Official title: Phase 1b/2a Clinical Study of AL58805 Combining With Other Anti-tumor Agents in Advanced, Metastatic GYN, STS or Breast Cancers

This phase 1b/2a study evaluates AL58805, an oral investigational drug that blocks PI3K and mTOR signaling, in combination with one of three anticancer treatments: AL8326 (veonetinib), eribulin, or fulvestrant. Adults with recurrent, advanced, or metastatic endometrial cancer, cervical cancer, soft tissue sarcoma, or breast cancer may be eligible after at least one prior standard treatment has failed or could not be tolerated and no effective standard treatment option remains.

In phase 1b, small groups of participants will receive different doses of AL58805 with a fixed dose of the partner treatment to identify a recommended combination dose based on dose-limiting side effects. In phase 2a, disease-specific groups will receive the selected combination dose to estimate the objective response rate and further evaluate duration of response, progression-free survival, overall survival, safety, pharmacokinetics, and exploratory tumor biomarkers. Protocol treatment may continue for up to 12 months, with continued treatment beyond 12 months possible for participants who remain clinically benefiting and receive investigator and sponsor approval.

Read the detailed description

AL-GB-805 is a global, multicenter, open-label, nonrandomized phase 1b/2a study of oral AL58805, a dual PI3K/mTOR inhibitor, combined with AL8326 (veonetinib), eribulin, or fulvestrant in adults with recurrent, advanced, or metastatic endometrial cancer, cervical cancer, soft tissue sarcoma (STS), or breast cancer for whom at least one prior standard treatment has failed or was not tolerated and no standard effective option remains.

Phase 1b uses a standard 3+3 dose-escalation/de-escalation design to select a regimen-specific recommended combination dose (RCD). AL58805 begins at 10 mg and may be increased to 20 mg or reduced to 5 mg based on dose-limiting toxicities (DLTs). Cohort A combines AL58805 with AL8326 40 mg in 28-day cycles; Cohort B combines AL58805 with eribulin 1.4 mg/m² intravenously on Days 1 and 8 of each 21-day cycle; and Cohort C combines AL58805 with fulvestrant 500 mg intramuscularly on Days 1, 15, and 29 and monthly thereafter in 28-day cycles. The RCD is the highest evaluated AL58805 dose at which fewer than 33% of evaluable participants experience a DLT during the first treatment cycle.

Phase 2a evaluates each regimen at its RCD. Cohort D includes separate endometrial cancer, cervical cancer, and STS groups receiving AL58805 plus AL8326. Cohort E includes separate STS and breast cancer groups receiving AL58805 plus eribulin. Cohort F includes an HR-positive or other eligible breast cancer group receiving AL58805 plus fulvestrant. Each disease-specific group initially enrolls 17 participants. Under the protocol-specified Simon two-stage design, a group with no objective responses stops for futility; a group with one or more objective responses may enroll 18 additional participants for a total of 35.

Tumor response is assessed by the investigator or local radiologist according to RECIST 1.1 at baseline and approximately every 8 weeks beginning on Cycle 3 Day 1. A complete response or partial response is confirmed by repeat imaging 4 to 6 weeks later. Treatment continues until disease progression, unacceptable toxicity, intercurrent illness that prevents safe treatment, withdrawal, sponsor discontinuation, or completion of 12 months of protocol treatment, whichever occurs first. Treatment beyond progression may be allowed when the investigator and sponsor determine that clinical benefit continues and urgent alternative intervention is not being delayed.

Participants who remain without progression and continue to benefit may receive study treatment beyond 12 months with investigator and sponsor approval under the protocol continued-access provisions or may later transition to a separate post-trial access protocol. Safety is monitored through the final study visit 4 to 5 weeks after the last study dose, and unresolved related adverse events and serious adverse events are followed until resolution or stabilization. Long-term follow-up includes vital status and subsequent anticancer therapy every 3 to 6 months.

Being tested
AL58805, AL8326, Eribulin, Fulvestrant
Medical subject headings
Endometrial Neoplasms, Sarcoma, Breast Neoplasms

What participants receive

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

  • AL58805Drug

    AL58805 is a novel chemical-structure antitumor drug with independent intellectual property rights. It functions as a novel dual-target PI3K/mTOR kinase inhibitor, exhibiting effects such as inhibiting tumor cell growth and proliferation, suppressing tumor nutrient metabolism, and exerting anti-angiogenic activity. By simultaneously inhibiting both PI3K and mTOR, it completely blocks the entire PI3K/AKT/mTOR signaling pathway at relatively low safe doses, thereby enhancing antitumor efficacy.

  • AL8326Drug

    AL8326 is a novel small molecule multi-receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr1, FGFr2, FGFr3), vascular endothelial growth factor receptor (VEGFr1, VEGFr2, VEGFr3) and Aurora-B.

  • EribulinDrug

    Eribulin Mesylate is a microtubule dynamics inhibitor used in the treatment of certain advanced solid tumors. It works by binding to tubulin, inhibiting the dynamic assembly and disassembly of microtubules, blocking mitosis in cancer cells, and inducing apoptosis.

  • FulvestrantDrug

    Fulvestrant is a class of estrogen receptor antagonist, estrogen receptor downregulation agents for anti-breast cancer treatment.

Study groups in NCT07811232
Study groupRoleWhat they receive
P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS cancer, RCD-A)ExperimentalThis cohort evaluates the safety and tolerability of AL8326 (40 mg) in combination with AL58805 (10 mg) in a 3+3 DLT evaluation design. If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg, it will be escalated to 20 mg.
Receives: Drug: AL58805; Drug: AL8326
P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Breast Cancer, RCD-B)ExperimentalThis cohort evaluates the safety and tolerability of Eribulin (1.4 mg/m²IV; 21 day-cycles of local standard) in combination with AL58805(10 mg). If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg bid, it will be escalated to 20 mg.
Receives: Drug: AL58805; Drug: Eribulin
P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Cancer, RCD-C)ExperimentalThis cohort evaluates the safety and tolerability of Fulvestrant (500 mg IM) in combination with AL58805 (10 mg). If DLT occurs, AL58805 will be reduced to 5 mg; If no DLT occurs at 10 mg, it will be escalated to 20 mg.
Receives: Drug: AL58805; Drug: Fulvestrant
P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical/STS cancer)ExperimentalThis cohort evaluates the safety and efficacy of AL8326 + AL58805 at RCD-A (determined from Cohort A) in patients with advanced Endometrial (n=17), Cervical (n=17) and STS cancer (n=17) (≥2nd line, age ≥18). Treatment continues until PD or intolerability.
Receives: Drug: AL58805; Drug: AL8326
P2a-Cohort E: (AL58805 + Eribulin, Breast cancer/Soft Tissue Sarcoma)ExperimentalThis cohort evaluates the safety and efficacy of Eribulin + AL58805 at RCD-B (determined from Cohort B) in patients with STS (n=17) and Breast cancer (n=17) (≥2nd-line, age ≥18). Treatment continues until PD or intolerability.
Receives: Drug: AL58805; Drug: Eribulin
P2a-Cohort F: (AL58805 + Fulvestrant, HR+/other Breast Cancer)ExperimentalThis cohort evaluates the safety and efficacy of Fulvestrant + AL58805 at RCD-C(determined from Cohort C) in patients with HR+/other Breast cancer (≥2nd-line, age ≥18). Treatment continues until PD or intolerability (n=17). Other breast cancer in phase 1b/2a: HER2-, PIK3CA mutant and PIK3CA Wild-Type etc.
Receives: Drug: AL58805; Drug: Fulvestrant

What is being measured

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

  1. Recommended Combination Dose (RCD)

    Determine the recommended combination dose (RCD) of AL58805 in combination with AL8326, Eribulin, or Fulvestrant based on the incidence of dose-limiting toxicities (DLTs) during Phase 1b. The RCD is defined as the highest evaluated dose level at which fewer than 33% of participants experience a DLT.

    Measured: 36 months

  2. Objective Tumor Response Rate (ORR)

    Percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) as the best overall tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: 36 months

Secondary outcomes (6)

  1. Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)

    Time from study drug administration to the observed maximum plasma concentration (Tmax) of AL58805, and of AL8326 where applicable, determined from protocol-specified pharmacokinetic sampling.

    Measured: 36 months

  2. Pharmacokinetic endpoint: Maximum Observed Plasma Concentration (Cmax)

    Maximum observed plasma concentration (Cmax) of AL58805, and of AL8326 where applicable, determined from plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Measured: 36 months

  3. Pharmacokinetic endpoint: Area Under the Plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of AL58805, and of AL8326 where applicable, calculated from plasma concentration-time data collected at protocol-specified pharmacokinetic sampling time points.

    Measured: 36 months

  4. Duration of Response (DOR)

    Time from the date of the first documented objective response, defined as Complete Response (CR) or Partial Response (PR), to the date of documented disease progression or death from any cause, whichever occurs first, according to RECIST version 1.1.

    Measured: 36 months

  5. Progression-Free Survival (PFS)

    Time from Cycle 1 Day 1 (C1D1) to the first documented disease progression or death from any cause, whichever occurs first.

    Measured: 36 months

  6. Overall Survival (OS)

    Time from Cycle 1 Day 1 (C1D1) to death from any cause.

    Measured: 36 months

Timeline

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

  1. First posted10 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Sep 2031 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811232
Sponsor's protocol ID
AL-GB-805
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wen W, Marcinkowski E, Luyimbazi D, Luu T, Xing Q, Yan J, Wang Y, Wu J, Guo Y, Tully D, Han ES, Yost SE, Yuan Y, Yim JH. Eribulin Synergistically Increases Anti-Tumor Activity of an mTOR Inhibitor by Inhibiting pAKT/pS6K/pS6 in Triple Negative Breast Cancer. Cells. 2019 Aug 30;8(9):1010. doi: 10.3390/cells8091010.

    PubMed 31480338

  • Gris-Oliver A, Ibrahim YH, Rivas MA, Garcia-Garcia C, Sanchez-Guixe M, Ruiz-Pace F, Viaplana C, Perez-Garcia JM, Llombart-Cussac A, Grueso J, Pares M, Guzman M, Rodriguez O, Anton P, Cozar P, Calvo MT, Bruna A, Arribas J, Caldas C, Dienstmann R, Nuciforo P, Oliveira M, Cortes J, Serra V. PI3K activation promotes resistance to eribulin in HER2-negative breast cancer. Br J Cancer. 2021 Apr;124(9):1581-1591. doi: 10.1038/s41416-021-01293-1. Epub 2021 Mar 15.

    PubMed 33723394

  • Lan C, Shen J, Wang Y, Li J, Liu Z, He M, Cao X, Ling J, Huang J, Zheng M, Zou G, Yan H, Liu Q, Yang F, Wei W, Deng Y, Xiong Y, Huang X. Camrelizumab Plus Apatinib in Patients With Advanced Cervical Cancer (CLAP): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2020 Dec 1;38(34):4095-4106. doi: 10.1200/JCO.20.01920. Epub 2020 Oct 14.

    PubMed 33052760

  • Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.

    PubMed 30943124

  • Tinker AV, Ellard S, Welch S, Moens F, Allo G, Tsao MS, Squire J, Tu D, Eisenhauer EA, MacKay H. Phase II study of temsirolimus (CCI-779) in women with recurrent, unresectable, locally advanced or metastatic carcinoma of the cervix. A trial of the NCIC Clinical Trials Group (NCIC CTG IND 199). Gynecol Oncol. 2013 Aug;130(2):269-74. doi: 10.1016/j.ygyno.2013.05.008. Epub 2013 May 11.

    PubMed 23672928

  • Zhang L, Wu J, Ling MT, Zhao L, Zhao KN. The role of the PI3K/Akt/mTOR signalling pathway in human cancers induced by infection with human papillomaviruses. Mol Cancer. 2015 Apr 17;14:87. doi: 10.1186/s12943-015-0361-x.

    PubMed 26022660

  • Tewari KS. Cervical Cancer. N Engl J Med. 2025 Jan 2;392(1):56-71. doi: 10.1056/NEJMra2404457. No abstract available.

    PubMed 39752299

  • Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.

    PubMed 37910822

  • Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

    PubMed 34534429

  • Motzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, Jassem J, Zolnierek J, Maroto JP, Mellado B, Melichar B, Tomasek J, Kremer A, Kim HJ, Wood K, Dutcus C, Larkin J. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov;16(15):1473-1482. doi: 10.1016/S1470-2045(15)00290-9. Epub 2015 Oct 22.

    PubMed 26482279

  • Matsuki M, Adachi Y, Ozawa Y, Kimura T, Hoshi T, Okamoto K, Tohyama O, Mitsuhashi K, Yamaguchi A, Matsui J, Funahashi Y. Targeting of tumor growth and angiogenesis underlies the enhanced antitumor activity of lenvatinib in combination with everolimus. Cancer Sci. 2017 Apr;108(4):763-771. doi: 10.1111/cas.13169. Epub 2017 Apr 20.

    PubMed 28107584

  • Vergote I, Powell MA, Teneriello MG, Miller DS, Garcia AA, Mikheeva ON, Bidzinski M, Cebotaru CL, Dutcus CE, Ren M, Kadowaki T, Funahashi Y, Penson RT. Second-line lenvatinib in patients with recurrent endometrial cancer. Gynecol Oncol. 2020 Mar;156(3):575-582. doi: 10.1016/j.ygyno.2019.12.039. Epub 2020 Jan 17.

    PubMed 31955859

  • Makker V, Taylor MH, Aghajanian C, Oaknin A, Mier J, Cohn AL, Romeo M, Bratos R, Brose MS, DiSimone C, Messing M, Stepan DE, Dutcus CE, Wu J, Schmidt EV, Orlowski R, Sachdev P, Shumaker R, Casado Herraez A. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer. J Clin Oncol. 2020 Sep 10;38(26):2981-2992. doi: 10.1200/JCO.19.02627. Epub 2020 Mar 13.

    PubMed 32167863

  • Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.

    PubMed 35045221

  • Dutt A, Salvesen HB, Chen TH, Ramos AH, Onofrio RC, Hatton C, Nicoletti R, Winckler W, Grewal R, Hanna M, Wyhs N, Ziaugra L, Richter DJ, Trovik J, Engelsen IB, Stefansson IM, Fennell T, Cibulskis K, Zody MC, Akslen LA, Gabriel S, Wong KK, Sellers WR, Meyerson M, Greulich H. Drug-sensitive FGFR2 mutations in endometrial carcinoma. Proc Natl Acad Sci U S A. 2008 Jun 24;105(25):8713-7. doi: 10.1073/pnas.0803379105. Epub 2008 Jun 13.

    PubMed 18552176

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AL58805, AL8326 and Eribulin in people with Endometrial Neoplasms and Soft Tissue Sarcoma (STS), run by Advenchen Pharmaceuticals, LLC. at 1 site 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 21 inclusion and 34 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: opening soon, as of the sponsor's last update on 10 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 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Queenie Yang, PhD (8055301550, queeniey@advenchen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Combination Dose (RCD) (time frame: 36 months). 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?

On the ClinicalTrials.gov record for NCT07811232, which also lists 22 linked publications.

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 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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