Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (NCT05891171) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
United States40 participantsStarted 2023-10-13
Plain-language summary
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.
* Monotherapy-specific criteria for dose escalation and PD cohorts:
* Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
* Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
* Dose Expansion cohort criteria:
* Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
* No prior systemic treatment for locally advanced unresectable or metastatic disease.
* Cannot have progressed within 6 months of prior platinum-based chemo…
What they're measuring
1
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 2 years
2
Dose Escalation Cohorts: Number of Participants with Dose-Limiting Toxicities (DLTs)