Health TrialsbyHealthPanel

XTX301 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXilio Development, Inc.

About this trial

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status of 0-2 for Phase 1

ECOG performance status of 0 or 1 for Phase 2

Adequate organ function

Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment

Disqualifiers

Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)

Known liver metastasis based on imaging

Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture

Active primary central nervous system (CNS) malignancy, CNS metastases, and/or carcinomatous meningitis

Trial design

Design model

Sequential

Treatments tested in this trial

  • XTX301

    Drug

    XTX301 monotherapy

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: Phase 1 - XTX301 Monotherapy Dose Escalation and Pharmacodynamics ExpansionExperimental treatment 1 intervention
Group B: Phase 2 - XTX301 Monotherapy Dose Expansion in Disease-Specific CohortsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose Limiting Toxicities (DLTs) (Part 1A only)

Time frame
From the first dose of the study drug at Cycle 1 Day 1 up to next applicable cycle visit (Cycle 2 Day 1 or Cycle 3 Day 1). Approximately 21 to 42 days. Each cycle is 21 days.
2

Incidence of treatment-emergent adverse events (TEAEs) and changes in clinical laboratory values

Time frame
Up to 24 months
3

Investigator-assessed objective response rate (ORR) per RECIST 1.1 (for all Phase 2 disease specific cohorts except CRPC/APMR-PC)

Time frame
up to 24 months
4

PSA50 response rate and Investigator-assessed ORR per RECIST 1.1 by CT/MRI for patients with measurable disease (for Phase 2 CRPC/APMR-PC cohort only)

Time frame
up to 24 months

Secondary outcomes

1

Plasma concentrations of XTX301

Time frame
Up to 24 months
2

Maximum observed plasma concentration (Cmax)

Time frame
Up to 24 months
3

Time of maximum observed concentration (Tmax)

Time frame
Up to 24 months
4

Trough concentration (Ctrough)

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xilio Development, Inc.

Lead sponsor

Source ClinicalTrials.gov
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