ABL103 plus pembrolizumab, with or without taxane, for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 study combines ABL103, an investigational agent, with pembrolizumab (Keytruda), and in some participants adds a taxane chemotherapy to determine tolerability and preliminary effectiveness in advanced or metastatic solid tumors. Phase 1 will focus on safety and identifying appropriate dose(s) and schedules, while Phase 2 will expand selected cohorts to measure anti-tumor activity and response rates. Eligible adults must have histologically or cytologically confirmed unresectable or metastatic solid tumors that are relapsed, refractory, or intolerant to standard therapies and meet ECOG performance status 0 or 1. The trial is sponsored by ABL Bio with collaboration from Merck and is being conducted at sites in the United States, Australia, and South Korea with regular on-site treatment and monitoring visits.

Why it matters

Who can join: the full rules

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 recovered to ≤Grade 1 or baseline. Subject with endocrine-related AEs who are adequately treated with hormone replacement or subjects who have ≤Grade 2 neuropathy are eligible.
* Subjects must have adequate hematologic, renal, hepatic, and thyroid function at screening and within 7 days prior to the first administration of study drug.
* Female subjects who are not surgically sterile or postmenopausal must agree to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of ABL103/pembrolizumab.
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and within 7 days prior to Cycle 1 Day 1 (C1D1).
* Male subjects with female partner(s) of childbearing potential must agree to use contraception and and must not donate sperm during the treatment period with ABL103 and taxane and for at least 6 months after the final administration of ABL103 and taxane.
* Male subjects with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period, and for at least 6 months after the final administration of ABL103 and taxane, and during the partner's pregnancy or breastfeeding period. When using a male condom, the partner must also use an additional method of contraception acceptable for female subjects.

Exclusion Criteria:

* Subject has received prior anticancer monoclonal antibody treatment or investigational therapy (agent or device) for which the pharmacologic or toxicity profile is not expected to have resolved prior to the first administration of the study drug. A minimum of 28 days is generally recommended for agents with known delayed toxicities or prolonged biological activity, unless otherwise justified.
* Subject has received prior radiotherapy within 2 weeks of the first administration of study drug, or has radiation-related toxicities, requiring corticosteroids.
* Subject has received any prior immunotherapy and was discontinued from the treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
* Subject has received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study treatment.
* Subject has risk factors for bowel obstruction or bowel perforation, including, but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis. Subjects with ovarian cancer with a history of abdominal carcinomatosis can be enrolled.

Where it's running

• Seoul National University Bundang Hospital
  Seongnam, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• UH Cleveland Medical Center
  Cleveland, Ohio, United States Not yet recruiting
• PASO Medical
  Frankston, Victoria, Australia Not yet recruiting
• Asan Medical Center
  Seoul, South Korea Not yet recruiting
• Samsung Medical Center
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Dayoung Ok
• Email: dayoung.ok@ablbio.com
• Phone: +82-2-3456-7300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.