Clinical Trials in the USA / NCT07767474
Recruiting
Phase 1/2
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
NCT07767474 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Advanced Solid Tumors
Investigational drug(s) / intervention(s)
ATX-898ATX-898ATX-898ATX-898ATX-898ATX-898, fulvestrant, ribociclibATX-898, fulvestrant, ribociclibATX-898, fulvestrant, ribociclib
ATX-898: Doses defined per protocol
ATX-898: RDE
ATX-898: RDE
ATX-898: RDE
ATX-898: Doses defined per protocol
ATX-898, fulvestrant, ribociclib: ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
ATX-898, fulvestrant, ribociclib: ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
ATX-898, fulvestrant, ribociclib: Doses defined per protocol
Study summary
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors. This study consists of 2 parts. Part 1 evaluates ATX-898 as monotherapy and Part 2 evaluates ATX-898 in combination with anti-neoplastic agents of interest. Both parts will consists of a dose escalation portion and a dose expansion portion.
Eligibility
Inclusion Criteria:
* Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable
* Is ≥18 years of age at the time of signing the informed consent form
* ECOG performance status score of 0 or 1
* Adequate organ function
* Must consent to a pre-treatment tumor biopsy (collected during screening or have available archival tumor tissue in the past 5 years.
For Part 1a (monotherapy dose escalation)
* Has received one or more standard systemic therapies and additional standard therapies are either not available, or participant ineligible for available standard therapies For Part 1b (monotherapy dose expansion)
* b1: Has platinum-resistant or refractory metastatic ovarian cancer
* b2: Has recurrent or metastatic gynecologic cancer excluding the cancers eligible for b1
* b3: Has recurrent advanced or metastatic solid tumor excluding the cancers eligible for b1 or b2
* Has at least 1 measurable lesion per RECIST 1.1
For Part 2a (combination dose escalation)
* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status
* Has received prior therapy in the metastatic For Part 2b (combination dose expansion)
* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status
* Treatment-naïve or has received prior therapy in the metastatic setting
Exclusion Criteria:
* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancer being studied
* Has symptomatic CNS metastases at screening or asymptomatic CNS metastases requiring corticosteroids to control symptoms within 28 days prior to the first dose of ATX-898.
* Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, with the exception of alopecia any grade and Grade ≤2 peripheral neuropathy
* Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or would prevent, limit, or confound the protocol-specified assessments
Cohort Specific:
* For abemaciclib cohorts only: has a history of any events of cardiac etiology that would contraindicate dosing with abemaciclib
* For ribocicilib only: has history of pneumonitis or interstitial lung disease
Primary outcome measure(s)
- Part 1a monotherapy dose escalation - Occurrence of Dose limiting toxicities (DLTs) — 12 months
Toxicities occurring within the first treatment cycle (28 days). DLTs will be assessed in severity by the investigators per CTCAE v 6.0 - Part 1a monotherapy dose escalation - Maximally tolerated/tested dose (MTD) — 12 months
Maximum dose deemed safe and well tolerated during dose escalation - Part 1a monotherapy dose escalation - Recommended dose for expansion (RDE) — 12 months
Monotherapy dose recommended to test during dose expansion - Part 1a monotherapy dose escalation - Treatment emergent adverse events (TEAEs) — 12 months
Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. - Part 1b monotherapy dose expansion - Objective Response Rate (ORR) — 24 months
Percentage of participants with confirmed CR or PR per RECIST 1.1 - Part 2a combination dose escalation - Occurrence of Dose limiting toxicities (DLTs) — 18 months
Toxicities occurring within the first treatment cycle of combination therapy (28 days). DLTs will be assessed in severity by the investigators per CTCAE v 6.0 - Part 2a combination dose escalation - Maximally tolerated/tested dose (MTD) — 18 months
Maximum dose deemed safe and well tolerated during dose escalation of with combination treatment - Part 2a combination dose escalation - Recommended dose for expansion (RDE) — 18 months
Recommended dose for expansion (RDE) Monotherapy dose recommended to test during dose expansion of combination treatment 18 months - Part 2a combination dose escalation - Treatment emergent adverse events (TEAEs) — 18 months
Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. 18 months - Part 2b combination dose expansion - Objective Response Rate (ORR) — 36 months
Percentage of participants with confirmed CR or PR per RECIST 1.1
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| START Dallas Fort Worth Cancer Center | Fort Worth | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| START San Antonio Cancer Center | San Antonio | Texas | Recruiting |
| START Mountain Region Cancer Center | West Valley City | Utah | Recruiting |
| NEXT Virginia Cancer Center- Merrifield Tech Center | Fairfax | Virginia | Recruiting |
| Linear Clinical Research | Perth | Western Australia | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07767474 on ClinicalTrials.gov ↗ ← All trials in the USA