A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors

Phase 2Not Yet RecruitingNCT07767474

Antares Therapeutics, Inc343 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

343

Conditions

Advanced Solid Tumors

Interventions

ATX-898DRUG

Doses defined per protocol

ATX-898DRUG

RDE

ATX-898DRUG

RDE

ATX-898DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Part 1a monotherapy dose escalation - Occurrence of Dose limiting toxicities (DLTs)

Toxicities occurring within the first treatment cycle (28 days). DLTs will be assessed in severity by the investigators per CTCAE v 6.0

Time frame: 12 months

Part 1a monotherapy dose escalation - Maximally tolerated/tested dose (MTD)

Maximum dose deemed safe and well tolerated during dose escalation

Time frame: 12 months

Part 1a monotherapy dose escalation - Recommended dose for expansion (RDE)

Monotherapy dose recommended to test during dose expansion

Time frame: 12 months

Part 1a monotherapy dose escalation - Treatment emergent adverse events (TEAEs)

Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Time frame: 12 months

Part 1b monotherapy dose expansion - Objective Response Rate (ORR)

Percentage of participants with confirmed CR or PR per RECIST 1.1

Time frame: 24 months

Part 2a combination dose escalation - Occurrence of Dose limiting toxicities (DLTs)

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

Time frame: 18 months

Part 2a combination dose escalation - Maximally tolerated/tested dose (MTD)

Maximum dose deemed safe and well tolerated during dose escalation of with combination treatment

Time frame: 18 months

Central Contacts

For questions concerning enrollment

CONTACT

000-000-0000 clinicaltrials@antaresrx.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Part 1a monotherapy dose escalation - Pharmacokinetic assessment Cmax

Cmax of ATX-898 following treatment

Time frame: 12 months

Part 1a monotherapy dose escalation - Pharmacokinetic assessment Tmax

Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment

Time frame: 12 Months

Part 1a monotherapy dose escalation - Pharmacokinetic assessment AUC

Area under the conc-time curve exposure of the study drug following treatment

Time frame: 12 Months

Part 1a monotherapy dose escalation - Pharmacokinetic assessment T 1/2

Time required for the concentration of study drug in the body to reduce by half following treatment

Time frame: 12 Months

Part 1a monotherapy dose escalation - Pharmacokinetic assessment Ctrough

Lowest measured concentration of study drug in the blood right before the next scheduled dose

Time frame: 12 Months

Part 1a monotherapy dose escalation - Objective Response Rate (ORR)

Percentage of participants with confirmed CR or PR per RECIST 1.1

Time frame: 12 months

Part 1b monotherapy dose expansion - Treatment emergent adverse events (TEAEs)

Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug

Time frame: 24 Months

Part 1b monotherapy dose expansion - Pharmacokinetic assessment Cmax

Cmax of ATX-898 following treatment at RDE

Time frame: 12 months

Part 1b monotherapy dose escalation - Pharmacokinetic assessment Tmax

Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment at RDE

Time frame: 12 Months

Part 1b monotherapy dose escalation - Pharmacokinetic assessment AUC

Area under the conc-time curve exposure of the study drug following treatment at RDE

Time frame: 12 Months

Part 1b monotherapy dose escalation - Pharmacokinetic assessment T 1/2

Time required for the concentration of study drug in the body to reduce by half following treatment at RDE

Time frame: 12 Months

Part 1b monotherapy dose escalation - Pharmacokinetic assessment Ctrough

Lowest measured concentration of study drug in the blood right before the next scheduled dose at RDE

Time frame: 12 Months

Part 2a combination dose escalation - Objective Response Rate (ORR)

Percentage of participants with confirmed CR or PR per RECIST 1.1

Time frame: 18 months

Part 2a monotherapy dose expansion - Pharmacokinetic assessment Cmax

Cmax of ATX-898 following treatment

Time frame: 12 months

Part 2a monotherapy dose escalation - Pharmacokinetic assessment Tmax

Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment

Time frame: 12 Months

Part 2a monotherapy dose escalation - Pharmacokinetic assessment AUC

Area under the conc-time curve exposure of the study drug following treatment

Time frame: 12 Months

Part 2a monotherapy dose escalation - Pharmacokinetic assessment T 1/2

Time required for the concentration of study drug in the body to reduce by half following treatment

Time frame: 12 Months

Part 2a monotherapy dose escalation - Pharmacokinetic assessment Ctrough

Lowest measured concentration of study drug in the blood right before the next scheduled dose

Time frame: 12 Months

Part 2b combination dose expansion - Treatment emergent adverse events (TEAEs)

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

Time frame: 36 months

Part 2b monotherapy dose expansion - Pharmacokinetic assessment Cmax

Cmax of ATX-898 following treatment at RDE when given in combination

Time frame: 12 months

Part 2b monotherapy dose escalation - Pharmacokinetic assessment Tmax

Time it takes for the study drug to reach peak concentration (Cmax) in the blood following treatment at RDE when given in combination

Time frame: 12 Months

Part 2b monotherapy dose escalation - Pharmacokinetic assessment AUC

Area under the conc-time curve exposure of the study drug following treatment at RDE when given in combination

Time frame: 12 Months

Part 2b monotherapy dose escalation - Pharmacokinetic assessment T 1/2

Time required for the concentration of study drug in the body to reduce by half following treatment at RDE when given in combination

Time frame: 12 Months

Part 2b monotherapy dose escalation - Pharmacokinetic assessment Ctrough

Lowest measured concentration of study drug in the blood right before the next scheduled dose at RDE when given in combination

Time frame: 12 Months