Antineoplastic Agents

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Tretinoin

XT-0528

Sherry L Plantholt, BS

Lynne Kelley, MD

This study is an open-label, Phase 1, multicenter, continuous dose escalation study of XT-0528 in adult subjects with Advanced or Metastatic Solid Tumor Malignancies.

The study will consist of 4 periods:

Screening Period (up to 28 days prior to Cycle 1 Day 1) Safety Run-in Period (Cycle 1; continuous dosing on Days 1-21 of 28-day cycle) Continuous Dosing Period (Cycle 2 and beyond; continuous dosing on Days 1-28 of 28-day cycle) Safety Follow-up Period (30 days post-last dose).

Primary Objective

* To determine the dose recommended for future Phase 2 studies (RP2D) that maximally suppresses T helper 17 (TH17) cell activities with an absence of dose limiting toxicity (DLT) and without exceeding the maximum tolerable dose (MTD).

Secondary Objective

* To establish the pharmacokinetics (PK) of orally administered XT-0528.
* To observe subjects for evidence of the antitumor activity of XT-0528.

Subjects With Advanced or Metastatic Solid Tumor Malignancies

A Phase 1, Multicenter Tolerability and Pharmacokinetic Study of Ascending Continuous Oral Doses of XT-0528 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

There are no plans to share information at this time.

Determination of Th17 cell suppression by measuring serum levels of Th17 cytokines before and during continuous dosing of XT-0528

Determination of MTD, in the continuous dosing setting, as assessed by collection of adverse event/serious adverse event (AE/SAE) information, if MTD is reached during dose escalation.

maximum plasma concentration at steady state (Cmax,ss)

area under the concentration-time curve calculated using linear trapezoidal rule from time zero to 24 hours, the dosing interval, after first dose (AUC0-t)

area under the concentration-time curve calculated using linear trapezoidal rule from time zero to 24 hours, the dosing interval, after first dose at Steady State (AUC0-tau)

To determine the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. \* Overall response rate (ORR) is defined as the proportion of participants whose best observed response is either a complete response (CR) or partial response (PR) per RECIST in the population of interest

To determine the median progression-free survival (PFS). Progression free survival (PFS) for a participant is defined as the time from first dosing date to the date of the first objectively documented disease progression per RECIST in the population of interest, or death due to any cause, whichever occurs first

Neutralizing antibody assessments will be performed in samples positive for ADA and will be analyzed to determine impact on rate and severity treatment-emergent adverse event(s) (TEAE).

To determine the median overall survival (OS). Overall survival (OS) is defined as the time from enrollment to the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Subjects With Advanced or Metastatic Solid Tumor Malignancies	NCT05474859	Metastatic Soli... Advanced Solid ...	XT-0528	18 Years -	Xenthera, Inc.
Subjects With Advanced or Metastatic Solid Tumor Malignancies	NCT05474859	Metastatic Soli... Advanced Solid ...	XT-0528	18 Years -	Xenthera, Inc.

Spots Global Cancer Trial Database for interleukin 17 (il17)