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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
ABL Bio, Inc.
Study ID
NCT07158918
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABL103 — DRUG
    IV infusion
  • KEYTRUDA® (pembrolizumab) — DRUG
    IV infusion
  • Taxane — DRUG
    IV infusion

Study Details

This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.

Key Dates

Start date
Aug 6, 2025
Status verified
Aug 2025
Primary completion
Dec 2, 2027
Completion
Dec 2, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UH Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By research site
UH Cleveland Medical Center· Cleveland, OH

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