ABL103 and Pembrolizumab for Advanced Solid Tumors
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Recruiting
Phase 1Phase 2Interventional Study
Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
65 (estimated)
Sponsor
ABL Bio, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors who have not responded to standard treatments. Participants will receive a combination of medications and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a confirmed diagnosis of an advanced solid tumor.
I have not responded to standard therapy or cannot tolerate it.
I am able to follow the study procedures.
I have recovered from past treatment side effects.
I have acceptable blood and organ function tests.
I understand the study and agree to participate.
I am willing to take precautions to prevent pregnancy.
You may not be able to join if
I have had recent anticancer therapy that is still affecting me.
I have received radiotherapy in the last 2 weeks.
I have had serious side effects from past immunotherapy.
I have received significant radiation to my lungs recently.
I have risk factors for bowel issues like blockages.
I have had a major health issue that requires current treatment.
I have a history of issues that could complicate my condition.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
Trial Locations
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Status
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…
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.
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