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Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors

NCT05571969 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-06-01

Study results available
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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-121 600 mg

Part 1 Cohort 1 receives 600 mg 2X-121 BID (200 mg morning + 400 mg evening)

DRUG

2X-121 800 mg

Part 1 Cohort 2 receives 800 mg 2X-121 BID (400 mg morning + 400 mg evening)

DRUG

2X-121 1000 mg

Part 1 Cohort 3 receives 1000 mg 2X-121 BID (400 mg morning + 600 mg evening)

COMBINATION_PRODUCT

2X-121 + 300 mg dovitinib

Part 2 Cohort 1 planned to receive 2X-121 at the MTD determined in Part 1, plus 300 mg dovitinib.

COMBINATION_PRODUCT

2X-121 + 400 mg dovitinib

Part 2 Cohort 2 was planned to receive 2X-121 at the MTD determined in Part 1, plus 400 mg dovitinib.

COMBINATION_PRODUCT

2X-121 + 500 mg dovitinib

Part 2 Cohort 3 was planned to received 2X-121 at the MTD determined in Part 1, plus 500 mg dovitinib.

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Allarity Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jeremy Graff · Allarity Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2024-02-19
Completion
2024-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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