ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Not Applicable
Recruiting
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT07158918
- Lead Sponsor
- ABL Bio, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ABL103 (DL1) + pembrolizumab ABL103 Safety Lead-in Part 1 ABL103 (DL1) + pembrolizumab KEYTRUDA® (pembrolizumab) Safety Lead-in Part 1 ABL103 (DL2-1) + pembrolizumab + taxane KEYTRUDA® (pembrolizumab) Safety Lead-in Part 2 ABL103 (DL2-1) + pembrolizumab + taxane ABL103 Safety Lead-in Part 2 ABL103 (DL2-1) + pembrolizumab + taxane Taxane Safety Lead-in Part 2 Group 1) ABL103 + pembrolizumab + taxane ABL103 Dose-expansion Part Group 1) ABL103 + pembrolizumab + taxane KEYTRUDA® (pembrolizumab) Dose-expansion Part Group 1) ABL103 + pembrolizumab + taxane Taxane Dose-expansion Part ABL103 (DL2) + pembrolizumab + taxane ABL103 Safety Lead-in Part 2 ABL103 (DL2) + pembrolizumab + taxane KEYTRUDA® (pembrolizumab) Safety Lead-in Part 2 ABL103 (DL2) + pembrolizumab + taxane Taxane Safety Lead-in Part 2 Group 2) ABL103 + pembrolizumab + taxane ABL103 Dose-expansion Part Group 2) ABL103 + pembrolizumab + taxane KEYTRUDA® (pembrolizumab) Dose-expansion Part Group 2) ABL103 + pembrolizumab + taxane Taxane Dose-expansion Part
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs) From baseline through study completion, an average of 12 months Recommended Dose for Expansion (RDE) Determination From baseline through study completion, an average of 12 months Objective Response Rate (ORR) Up to approximately 30 months Disease Control Rate (DCR) Up to approximately 30 months Incidence of Dose-Limiting Toxicities (DLTs) Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
- Secondary Outcome Measures
Name Time Method Preliminary Objective Response Rate (ORR) Up to approximately 30 months Preliminary Disease Control Rate (DCR) Up to approximately 30 months Incidence of Anti-Drug Antibodies (ADA) From baseline through study completion, an average of 12 months
Trial Locations
- Locations (6)
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
PASO Medical
🇦🇺Frankston, Victoria, Australia
Seoul National University Bundang Hospital
🇰🇷Seongnam, South Korea
Seoul National University Hospital
🇰🇷Seoul, South Korea
Asan Medical Center
🇰🇷Seoul, South Korea
Samsung Medical Center
🇰🇷Seoul, South Korea
UH Cleveland Medical Center🇺🇸Cleveland, Ohio, United States