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

NCT07158918 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: ABL103-1002KEYNOTE-G16MK-3475-G16
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 6

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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)

• 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

Secondary Outcomes (3)

• 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

Study Arms (5)

ABL103 (DL1) + pembrolizumab

EXPERIMENTAL

Safety Lead-in Part 1

Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab)

ABL103 (DL2-1) + pembrolizumab + taxane

EXPERIMENTAL

Safety Lead-in Part 2

Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane

ABL103 (DL2) + pembrolizumab + taxane

EXPERIMENTAL

Safety Lead-in Part 2

Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane

Group 1) ABL103 + pembrolizumab + taxane

EXPERIMENTAL

Dose-expansion Part

Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane

Group 2) ABL103 + pembrolizumab + taxane

EXPERIMENTAL

Dose-expansion Part

Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane

Interventions

ABL103 DRUG

IV infusion

ABL103 (DL1) + pembrolizumab; ABL103 (DL2) + pembrolizumab + taxane; ABL103 (DL2-1) + pembrolizumab + taxane; Group 1) ABL103 + pembrolizumab + taxane; Group 2) ABL103 + pembrolizumab + taxane

KEYTRUDA® (pembrolizumab) DRUG

IV infusion

ABL103 (DL1) + pembrolizumab; ABL103 (DL2) + pembrolizumab + taxane; ABL103 (DL2-1) + pembrolizumab + taxane; Group 1) ABL103 + pembrolizumab + taxane; Group 2) ABL103 + pembrolizumab + taxane

Taxane DRUG

IV infusion

ABL103 (DL2) + pembrolizumab + taxane; ABL103 (DL2-1) + pembrolizumab + taxane; Group 1) ABL103 + pembrolizumab + taxane; Group 2) ABL103 + pembrolizumab + taxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABL Bio, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

PASO Medical

Frankston, Victoria, 3199, Australia

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

MeSH Terms

Interventions

pembrolizumab; taxane

Study Officials

• Sangmi Lee

  ABL Bio

  STUDY DIRECTOR

Central Study Contacts

Dayoung Ok

CONTACT

+82-2-3456-7300; dayoung.ok@ablbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and Dose expansion

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 8, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): December 2, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

AU (1); KR (4); US (1)