Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid… (NCT05653661) | Clinical Trial Compass
WithdrawnPhase 1
Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors
Stopped: Sponsor business considerations
United States0Started 2024-07-30
Plain-language summary
This phase I trial tests the safety, side effects, and best dose of a new drug called nab-paclitaxel/STI-3031 complex (AP160-complex) in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other distant parts of the body (metastatic). AP160-complex is a combination of the chemotherapy drug nab-paclitaxel, and the immunotherapy drug STI-3031. Nab-paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. AP160-complex may work better than standard therapies in treating advanced or metastatic solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provide written informed consent
* PRE-REGISTRATION
* Age \>= 18 years
* Willingness to provide mandatory pre-registration tissue specimen for research
* At least one prior systemic therapy in the metastatic setting (adjuvant or neoadjuvant therapy not included).
* NOTE: There is no upper limit to the number of prior treatment regimens
* Dose Escalation Cohort Only
* Patients with histologically or cytologically confirmed advanced or metastatic non-neurological solid tumors, who have no curative or life prolonging therapeutic options
* Melanoma Dose Expansion Cohort Only
* Histologic proof of surgically unresectable stage IV malignant melanoma
* Disease progression on or after anti-PD1/PDL1 antibody-based therapy in the metastatic setting (adjuvant or neoadjuvant therapy with anti-PD1/PDL1 antibody do not count)
* REGISTRATION
* Tissue submitted for testing at pre-registration shows minimal level of tumor staining for PDL1 (clinical test using 22c3 immunohistochemistry) demonstrating tumor staining in \>= 1% of tumor cells
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
* Hemoglobin \>= 9.0 g/dL (patients may be transfused to meet hemoglobin \[Hgb\] requirement) (obtained =\< 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
* Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
* Total bilirubin =\< 1.5 x upper li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.