Health Trials

Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments

ConditionsAdvanced Solid TumorsPancreatic CarcinomaOvarian CancerCervical Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvopoint Biosciences Inc.

About this trial

This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies or are intolerant to such therapies. The study consists of two parts: a dose escalation part and a dose expansion part.

Eligibility criteria

Qualifiers

For the dose escalation part: subjects with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have failed the established standard anti-cancer therapies for a given tumor type or have been intolerant to such therapies.

For the dose expansion part: subjects must have a histological or cytological diagnosis of progressive, locally advanced, and/or metastatic ovarian cancer, cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed the following anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer, Colorectal cancer.

Age ≥ 18 years old at the time of consent.

Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).

Disqualifiers

A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs) or allergic reactions to any components of XNW28012.

Any anti-tumor therapy within 28 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs.

Any active malignancy, with the exception of the specific types of cancers under investigation in this study and any locally recurring cancer that has been treated curatively .

Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines.

Trial design

Treatments tested in this trial

  • XNW28012

Treatment groups

350 Participants
are divided into 1 treatment group

Sponsors and collaborators

Evopoint Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov