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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07158918




Registration number
NCT07158918
Ethics application status
Date submitted
8/08/2025
Date registered
8/09/2025
Date last updated
8/09/2025

Titles & IDs
Public title
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Scientific title
A Multicenter, Open-label, Phase 1b/2 Trial of ABL103, a Bispecific Antibody of B7-H4 and 4-1BB, in Combination With Pembrolizumab With/Without Taxane in Subjects With Selected, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
Secondary ID [1] 0 0
KEYNOTE-G16
Secondary ID [2] 0 0
ABL103-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABL103
Treatment: Drugs - KEYTRUDA® (pembrolizumab)
Treatment: Drugs - Taxane

Experimental: ABL103 (DL1) + pembrolizumab - Safety Lead-in Part 1

Experimental: ABL103 (DL2-1) + pembrolizumab + taxane - Safety Lead-in Part 2

Experimental: ABL103 (DL2) + pembrolizumab + taxane - Safety Lead-in Part 2

Experimental: Group 1) ABL103 + pembrolizumab + taxane - Dose-expansion Part

Experimental: Group 2) ABL103 + pembrolizumab + taxane - Dose-expansion Part


Treatment: Drugs: ABL103
IV infusion

Treatment: Drugs: KEYTRUDA® (pembrolizumab)
IV infusion

Treatment: Drugs: Taxane
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs)
Timepoint [2] 0 0
From baseline through study completion, an average of 12 months
Primary outcome [3] 0 0
Recommended Dose for Expansion (RDE) Determination
Timepoint [3] 0 0
From baseline through study completion, an average of 12 months
Primary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 30 months
Primary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
Up to approximately 30 months
Secondary outcome [1] 0 0
Preliminary Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 30 months
Secondary outcome [2] 0 0
Preliminary Disease Control Rate (DCR)
Timepoint [2] 0 0
Up to approximately 30 months
Secondary outcome [3] 0 0
Incidence of Anti-Drug Antibodies (ADA)
Timepoint [3] 0 0
From baseline through study completion, an average of 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2027
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
PASO Medical - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
South Korea
State/province [2] 0 0
Seongnam
Country [3] 0 0
South Korea
State/province [3] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ABL Bio, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sangmi Lee
Address 0 0
ABL Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dayoung Ok
Address 0 0
Country 0 0
Phone 0 0
+82-2-3456-7300
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07158918