> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-atx-898-in-participants-with-advanced-898c7da3-5af1-4054-a022-f60b3e744bd3 > Record changed: 2026-10-13 # A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors NCT07767474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) Participants 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) Lead sponsor Antares Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) Start date 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Short title** A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Official title** First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Dates **Completion date** 2030-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **First posted** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Primary completion date** 2028-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Start date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Size and sites **Participants** 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Planned participants** 343 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Lead sponsor** Antares Therapeutics, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Identifiers **Registry ID** NCT07767474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **ClinicalTrials.gov ID** NCT07767474 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Outcomes ### Primary outcomes 1. Part 1a monotherapy dose escalation - Occurrence of Dose limiting toxicities (DLTs) Timeframe: 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 2. Part 1a monotherapy dose escalation - Maximally tolerated/tested dose (MTD) Timeframe: 12 months Maximum dose deemed safe and well tolerated during dose escalation 3. Part 1a monotherapy dose escalation - Recommended dose for expansion (RDE) Timeframe: 12 months Monotherapy dose recommended to test during dose expansion 4. Part 1a monotherapy dose escalation - Treatment emergent adverse events (TEAEs) Timeframe: 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. 5. Part 1b monotherapy dose expansion - Objective Response Rate (ORR) Timeframe: 24 months Percentage of participants with confirmed CR or PR per RECIST 1.1 6. Part 2a combination dose escalation - Occurrence of Dose limiting toxicities (DLTs) Timeframe: 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 7. Part 2a combination dose escalation - Maximally tolerated/tested dose (MTD) Timeframe: 18 months Maximum dose deemed safe and well tolerated during dose escalation of with combination treatment 8. Part 2a combination dose escalation - Recommended dose for expansion (RDE) Timeframe: 18 months Recommended dose for expansion (RDE) Monotherapy dose recommended to test during dose expansion of combination treatment 18 months 9. Part 2a combination dose escalation - Treatment emergent adverse events (TEAEs) Timeframe: 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 10. Part 2b combination dose expansion - Objective Response Rate (ORR) Timeframe: 36 months Percentage of participants with confirmed CR or PR per RECIST 1.1 ### Secondary outcomes 1. Part 1a monotherapy dose escalation - Pharmacokinetic assessment Cmax Timeframe: 12 months Cmax of ATX-898 following treatment 2. Part 1a monotherapy dose escalation - Pharmacokinetic assessment Tmax Timeframe: 12 Months Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment 3. Part 1a monotherapy dose escalation - Pharmacokinetic assessment AUC Timeframe: 12 Months Area under the conc-time curve exposure of the study drug following treatment 4. Part 1a monotherapy dose escalation - Pharmacokinetic assessment T 1/2 Timeframe: 12 Months Time required for the concentration of study drug in the body to reduce by half following treatment 5. Part 1a monotherapy dose escalation - Pharmacokinetic assessment Ctrough Timeframe: 12 Months Lowest measured concentration of study drug in the blood right before the next scheduled dose 6. Part 1a monotherapy dose escalation - Objective Response Rate (ORR) Timeframe: 12 months Percentage of participants with confirmed CR or PR per RECIST 1.1 7. Part 1b monotherapy dose expansion - Treatment emergent adverse events (TEAEs) Timeframe: 24 Months Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug 8. Part 1b monotherapy dose expansion - Pharmacokinetic assessment Cmax Timeframe: 12 months Cmax of ATX-898 following treatment at RDE 9. Part 1b monotherapy dose escalation - Pharmacokinetic assessment Tmax Timeframe: 12 Months Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment at RDE 10. Part 1b monotherapy dose escalation - Pharmacokinetic assessment AUC Timeframe: 12 Months Area under the conc-time curve exposure of the study drug following treatment at RDE 11. Part 1b monotherapy dose escalation - Pharmacokinetic assessment T 1/2 Timeframe: 12 Months Time required for the concentration of study drug in the body to reduce by half following treatment at RDE 12. Part 1b monotherapy dose escalation - Pharmacokinetic assessment Ctrough Timeframe: 12 Months Lowest measured concentration of study drug in the blood right before the next scheduled dose at RDE 13. Part 2a combination dose escalation - Objective Response Rate (ORR) Timeframe: 18 months Percentage of participants with confirmed CR or PR per RECIST 1.1 14. Part 2a monotherapy dose expansion - Pharmacokinetic assessment Cmax Timeframe: 12 months Cmax of ATX-898 following treatment 15. Part 2a monotherapy dose escalation - Pharmacokinetic assessment Tmax Timeframe: 12 Months Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment 16. Part 2a monotherapy dose escalation - Pharmacokinetic assessment AUC Timeframe: 12 Months Area under the conc-time curve exposure of the study drug following treatment 17. Part 2a monotherapy dose escalation - Pharmacokinetic assessment T 1/2 Timeframe: 12 Months Time required for the concentration of study drug in the body to reduce by half following treatment 18. Part 2a monotherapy dose escalation - Pharmacokinetic assessment Ctrough Timeframe: 12 Months Lowest measured concentration of study drug in the blood right before the next scheduled dose 19. Part 2b combination dose expansion - Treatment emergent adverse events (TEAEs) Timeframe: 36 months Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug when given in combination 20. Part 2b monotherapy dose expansion - Pharmacokinetic assessment Cmax Timeframe: 12 months Cmax of ATX-898 following treatment at RDE when given in combination 21. Part 2b monotherapy dose escalation - Pharmacokinetic assessment Tmax Timeframe: 12 Months Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment at RDE when given in combination 22. Part 2b monotherapy dose escalation - Pharmacokinetic assessment AUC Timeframe: 12 Months Area under the conc-time curve exposure of the study drug following treatment at RDE when given in combination 23. Part 2b monotherapy dose escalation - Pharmacokinetic assessment T 1/2 Timeframe: 12 Months Time required for the concentration of study drug in the body to reduce by half following treatment at RDE when given in combination 24. Part 2b monotherapy dose escalation - Pharmacokinetic assessment Ctrough Timeframe: 12 Months Lowest measured concentration of study drug in the blood right before the next scheduled dose at RDE when given in combination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07767474) ## Related records ### Drugs (2) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Ribociclib](https://trialight.com/data/asset/ribociclib-e1583670-a6ef-48c5-8d6a-4d83f85a626d.md) ### Lead sponsors (1) - [Antares Therapeutics, Inc](https://trialight.com/data/company/antares-therapeutics-inc-ab799c6f-d9a3-4508-85a3-d8d11d710b15.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (3) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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