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

Part of paid clinical trials in Houston, Texas.

Sponsor
Advenchen Pharmaceuticals, LLC.
Study ID
NCT07811232
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Sep 10, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
138 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Recommended Combination Dose (RCD) [ Time Frame: 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Marium Kaukab, MBBS, CCRP
[email protected]
713-792-9868
Jeffrey Andrew How, MD, MPH, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials
By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies