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Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination With 2X-121 in Patients With Advanced Solid Tumors

NCT05571969 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-07

No results posted yet for this study

Summary

This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.

Conditions

Interventions

DRUG

2X-121 and dovitinib

The dose levels to be evaluated in Part 1 are: Cohort 1 600 mg (morning dose: 200 mg + evening dose: 400 mg); Cohort 2 800 mg (morning dose: 400 mg + evening dose: 400 mg); Cohort 3 1000 mg (morning dose: 400 mg + evening dose: 600 mg); The dose levels to be evaluated in Part 2 are: Cohort 1 2X-121 (MTD) + 300 mg dovitinib; Cohort 2 2X-121 (MTD) + 400 mg dovitinib; Cohort 3 2X-121 (MTD) + 500 mg dovitinib;

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Allarity Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-10-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571969 on ClinicalTrials.gov