Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
XNW28012
DrugEligible subjects will receive XNW28012 every 3 weeks (Q3W) until intolerant toxicity, progression of disease with no clinical benefit, or withdrawal of informed consent.
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Bayesian Optimal Interval (BOIN) method will be used for the dose escalation part.Other 1 intervention
Trial outcomes
Primary outcomes
1
Ph 1: Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability].
Incidence and severity of adverse events that are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame
through study completion, an average of 1 year2
Ph 2: To evaluate the antitumor efficacy of XNW28012 at the recommended Part 2 dose.
ORR per RECIST1.1 assessed by Investigators.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Ph 1:Maximum tolerated dose (MTD) and/or the recommended Part 2 dose.
To determine the maximum tolerated dose (MTD) and the recommended Part 2 dose with XNW28012;
Time frame
The first 21-day cycle of therapy2
Ph 1/II: Maximum (peak) observed concentration (Cmax) of XNW28012.
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame
through study completion, an average of 1 year3
Ph 1/II: Maximum (peak) observed concentration (Cmax) of total antibody of XNW28012..
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame
through study completion, an average of 1 year4
Ph 1/II: Maximum (peak) observed concentration (Cmax) of YL0010014
Blood samples were collected at specified intervals for the determination of Cmax.
Time frame
through study completion, an average of 1 yearOther outcomes
1
Ph 1/2: Tissue factor expression
Correlation between tissue factor expression and the antitumor efficacy of XNW28012.
Time frame
At screeningSponsors and contacts
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Source ClinicalTrials.gov