First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors
Study Identifier:
ATX-898-101
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Ovarian
Solid Tumor
Soft Tissue Sarcoma
Endometrial
Cervical cancer
Fallopian Tube
Vulvar
Primary Peritoneal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1a: Monotherapy Dose Escalation
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Drug: ATX-898 will be given at a protocol defined starting dose for the treatment of participants with selected advanced or metastatic solid tumors.
Drug: Subsequent dose regimen will be determined during study execution
Drug: Drug: ATX-898
Drug: Doses defined per protocol
Drug: EXPERIMENTAL: Part 1b1: Monotherapy Dose Expansion Cohort Disease Group 1
Drug: ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic ovarian cancer
Drug: RDE
Drug: EXPERIMENTAL: Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 2
Drug: ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic gynecologic cancers other than ovarian cancers
Drug: EXPERIMENTAL: Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 3
Drug: ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic solid tumors other than gynecologic cancers
Drug: EXPERIMENTAL: Part 2a 1: Combination Dose Escalation
Drug: ATX-898 will be given at a recommended starting dose in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer. Subsequent dose regimen of ATX-898 will be determined during study execution
Drug: EXPERIMENTAL: Part 2a 2: Combination Dose Escalation
Drug: ATX-898 will be given at a recommended starting dose in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer Subsequent dose regimen of ATX-898 will be determined during study execution
Drug: Drug: ATX-898, fulvestrant, ribociclib
Drug: EXPERIMENTAL: Part 2b 1: Combination Dose Expansion
Drug: ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer
Drug: ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
Drug: EXPERIMENTAL: Part 2b 2: Combination Dose Expansion
Drug: ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Ovarian
Solid Tumor
Soft Tissue Sarcoma
Endometrial
Cervical cancer
Fallopian Tube
Vulvar
Primary Peritoneal
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Ovarian
Solid Tumor
Soft Tissue Sarcoma
Endometrial
Cervical cancer
Fallopian Tube
Vulvar
Primary Peritoneal
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Ovarian
Solid Tumor
Soft Tissue Sarcoma
Endometrial
Cervical cancer
Fallopian Tube
Vulvar
Primary Peritoneal