NCT07811297
A Study of Catequentinib Hydrochloride (AL3818) in Endometrial, LGSOC, STS or GBM Cancers
Not Yet Recruiting · Phase 1, Phase 2 · Advenchen Pharmaceuticals, LLC. · registry updated 2026-09-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase 1b/2a study evaluates the investigational oral drug catequentinib hydrochloride (AL3818), given alone or with AL58805, temozolomide, or lomustine (CCNU), in adults with advanced or metastatic solid tumors. The phase 1b part will identify doses that can be given safely based on side effects during the first treatment cycle. The phase 2a part will estimate whether the treatments shrink non-brain tumors or keep glioblastoma from worsening for at least 6 months. The study is open label, which means participants and study investigators will know which treatment is given. Tumor response will be assessed with RECIST version 1.1. The study will also evaluate how the investigational drugs move through the body, the duration of tumor response, progression-free survival, overall survival, and treatment safety.
Inclusion
- 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 NSCLC, SCLC, STS, Thyroid, Endometrial, LGSOC, GBM and breast cancer (Phase 2a: STS, Endometrial, LGSOC and GBM ); GBM can only have histological confirmation of diagnosis;
- Failure of at least 1 prior line of standard therapy (disease progression after treatment or intolerable treatment toxicities); concurrent chemoradiation therapy and adjuvant chemotherapy such as containing temozolomide will be considered as 1 line of prior therapy
- no standard or effective treatment available.
Exclusion
- 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, targeted therapies, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment. Prior bevacizumab or other antiangiogenic therapies for phase 2 part of the GBM cohort (however, use of bevacizumab for radiation necrosis or toxicity is allowed unless it is within 28 days 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., AL3818, AL58805, temozolomide, CCNU, etc.) and excipients. (For example, patients who have had severe allergic reactions such as rash or anaphylactic shock after previous use of temozolomide.)
- 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.