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

NCT07811232 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AL-GB-805
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial Neoplasms; Soft Tissue Sarcoma (STS); Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

  36 months

• 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.

  36 months

Secondary Outcomes (6)

• Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)

  36 months

• Pharmacokinetic endpoint: Maximum Observed Plasma Concentration (Cmax)

  36 months

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

  36 months

• Duration of Response (DOR)

  36 months

• Progression-Free Survival (PFS)

  36 months

Study Arms (6)

P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS cancer, RCD-A)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: AL8326

P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Breast Cancer, RCD-B)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: Eribulin

P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Cancer, RCD-C)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: Fulvestrant

P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical/STS cancer)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: AL8326

P2a-Cohort E: (AL58805 + Eribulin, Breast cancer/Soft Tissue Sarcoma)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: Eribulin

P2a-Cohort F: (AL58805 + Fulvestrant, HR+/other Breast Cancer)

EXPERIMENTAL

This 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.

Drug: AL58805; Drug: Fulvestrant

Interventions

AL58805 DRUG

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.

P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS cancer, RCD-A); P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Breast Cancer, RCD-B); P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Cancer, RCD-C); P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical/STS cancer); P2a-Cohort E: (AL58805 + Eribulin, Breast cancer/Soft Tissue Sarcoma); P2a-Cohort F: (AL58805 + Fulvestrant, HR+/other Breast Cancer)

AL8326 DRUG

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.

P1b-Cohort A: (AL58805 + AL8326 Endometrial/Cervical/STS cancer, RCD-A); P2a-Cohort D: (AL58805 + AL8326, Endometrial/Cervical/STS cancer)

Eribulin DRUG

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.

P1b-Cohort B: (AL58805 + Eribulin, Soft Tissue Sarcoma/Breast Cancer, RCD-B); P2a-Cohort E: (AL58805 + Eribulin, Breast cancer/Soft Tissue Sarcoma)

Fulvestrant DRUG

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

P1b-Cohort C: (AL58805 + Fulvestrant, HR+/other Breast Cancer, RCD-C); P2a-Cohort F: (AL58805 + Fulvestrant, HR+/other Breast Cancer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.
• a. 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.

Sponsors & Collaborators

• Advenchen Pharmaceuticals, LLC.: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Endometrial Neoplasms; Sarcoma; Breast Neoplasms

Interventions

eribulin; Fulvestrant

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Judy Chen

  Advenchen Pharmaceuticals, LLC.

  STUDY DIRECTOR

• Jeffrey A How, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Queenie Yang, PhD

CONTACT

8055301550; queeniey@advenchen.com

Judy Chen

CONTACT

judc@advenchen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)