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Recruiting Phase 1, Phase 2 NCT07158918

ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors

Trial Parameters

Condition Solid Tumors
Sponsor ABL Bio, Inc.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-06
Completion 2027-12-02
Interventions
ABL103KEYTRUDA® (pembrolizumab)Taxane

Brief Summary

This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria: * Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions. * Subjects must be ≥18 years of age on the day of signing the informed consent form (ICF). * Subject must have a histologically or cytologically confirmed locally advanced unresectable, or metastatic solid tumor. * Subject must be relapsed or be refractory to available standard therapy or they must be intolerant of available standard therapy. * Subject must meet Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 assessed 7 days before the first administration of the study drug. * Subjects must be recovered from AEs from prior therapy to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug, except alopecia or Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) * Subjects who have AEs due to previous anticancer therapies must have recove

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